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Clinical Trials

Research scientists and physicians are constantly trying to learn more about disease conditions. They try to understand the causes, how to prevent or delay development, or how to treat symptoms. When this research leads to a new treatment that could benefit patients, researchers first conduct tests in the laboratory. This research helps focus in on methods most likely to help patients and offers valuable information about how to use these methods safely and effectively. However, laboratory research cannot predict all of the benefits, risks or effects that may emerge in actual patients.

A cancer treatment clinical trial is a study conducted with patients in order to evaluate a new therapy, diagnostic test or prevention method. Each study is designed to answer scientific questions that enable the medical community to find better ways to help patients. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more and more information is gained about a new treatment, its risks and how well it may or may not work.

The standard treatments being used in hospitals today are the result of clinical trials done in the past. They are also often used as building blocks for new and better treatments in the future. Some new treatments are designed based on what has worked in the past while others are based on new advances in science and technology.

Participation in cancer treatment clinical trials is always voluntary. If you are interested in a clinical trial or asked to participate in one, learn as much as you can before you make up your mind. Only patients who want to participate will take part and all participants can change their minds at any time without losing any benefits. Always remember that you are in control of your medical treatment.

Advantages of Participating In a Trial

Cancer Treatment Clinical Trials

Medical science continues to advance the frontiers of understanding and develop new and effective treatments for many medical conditions. In many cases, life-saving treatments that define the current standard of care today were unheard of a decade ago. Similarly, work taking place right now in research laboratories will make some of our current treatments obsolete, offering hope to patients who currently have few effective options.

Cancer treatment clinical trials give patients the opportunity to play a role in developing promising new therapies and in ensuring that these therapies become available to all patients in need. Without the benefit of the valuable information gained through clinical trials, medical research could not move forward as it does.

Participating in a clinical trial can aid you directly by giving you access to potentially helpful treatments before they are available to the general public. Your participation may mean that you are among the first to benefit from the latest cutting-edge research as it moves out of the laboratory and into doctors' hands.

Who can participate in a cancer treatment clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What happens during a cancer treatment clinical trial?

The clinical trial process depends on the kind of trial being conducted (See Different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

The benefits and risks of participating in a clinical trial?

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

  • Play an active role in their health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks

There are risks to clinical trials.

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Side effects and Adverse Reactions

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Different types of cancer treatment clinical trials?

  • Treatment. These trials test the effectiveness of new treatments or new ways of using current treatments in people who have cancer. The treatments tested may include new drugs or new combinations of currently used drugs, new surgery or radiation therapy techniques, and vaccines or other treatments that stimulate a person’s immune system to fight cancer. Combinations of different treatment types may also be tested in these trials.

  • Prevention. These trials test new interventions that may lower the risk of developing certain types of cancer. Most cancer prevention trials involve healthy people who have not had cancer; however, they often only include people who have a higher than average risk of developing a specific type of cancer. Some cancer prevention trials involve people who have had cancer in the past; these trials test interventions that may help prevent the return (recurrence) of the original cancer or reduce the chance of developing a new type of cancer

  • Screening. These trials test new ways of finding cancer early. When cancer is found early, it may be easier to treat and there may be a better chance of long-term survival. Cancer screening trials usually involve people who do not have any signs or symptoms of cancer. However, participation in these trials is often limited to people who have a higher than average risk of developing a certain type of cancer because they have a family history of that type of cancer or they have a history of exposure to cancer-causing substances (e.g., cigarette smoke).

  • Diagnostic. These trials study new tests or procedures that may help identify, or diagnose, cancer more accurately. Diagnostic trials usually involve people who have some signs or symptoms of cancer.

  • Quality of life or supportive care. These trials focus on the comfort and quality of life of cancer patients and cancer survivors. New ways to decrease the number or severity of side effects of cancer or its treatment are often studied in these trials. How a specific type of cancer or its treatment affects a person’s everyday life may also be studied.


Clinical Trial Phases

Cancer Treatment Clinical Trial Phases

The testing of new treatments in clinical trials is divided into four phases:

Phase I trials help researchers determine the most appropriate dosage and to identify any side effects that may be associated with the new treatment. This phase also helps determine the best way to deliver the new treatment – for example if a drug should be given by injection or by mouth. Phase I trials typically involve fewer than 100 participants.

Phase II trials test the treatment in patients who have the targeted medical condition in order to begin determining its effectiveness. Researchers continue to track the drug's safety and side effects. Phase II trials involve more patients, but are still very limited in size.

Phase III trials compare the new treatment to one or more standard therapies currently in use among patients. The new treatment is sometimes combined with established therapies to determine if the combination is more effective than standard therapy alone. Safety and side effects continue to be tracked as the study expands to include hundreds or even thousands of patients.

Phase IV trials can begin once the treatment is approved for general use to continue to monitor its safety and effectiveness and to give researchers and physicians additional information about how best to employ the new treatment.


The Role of the FDA

The Role of the FDA

The Food and Drug Administration (FDA) is the federal agency responsible for making sure that new drugs and medical devices are safe and effective. No treatment is risk-free, but it is the FDA's role to judge whether a new treatment's benefits to the patient outweigh its risks. They oversee every phase of a clinical trial and decide if the evidence supports continued testing and, eventually, approval for doctors to prescribe the new treatment in this country.


Informed Consent

Informed Consent

The informed consent process provides patients the information they need in order to make an educated decision to begin or continue to participate in a clinical trial. The research team will discuss with you the trial's purpose, procedures, risks and potential benefits, and your rights as a participant. The team will also provide a document that includes all this information for your reference throughout the study and will continue to provide information to you during your participation in the trial. Your signature on the informed consent document gives your official consent to participate in the study, but you always retain the right to leave the study at any time for any reason.


Who Sponsors Clinical Trials

Who Sponsors Clinical Trials?

The sponsor can be the pharmaceutical company, research institution, or health organization that funds a clinical trial. This funding source can be a commercial enterprise, a governmental agency, or a philanthropic organization.


Cost of Participation

Cost of Participation

The research costs associated with a clinical trial, including data collection and analysis, health care professionals who work on the research project, and tests performed for research purposes are paid by the research sponsor.

Other costs for medical goods and services, including doctors' professional fees, hospital stays, laboratory tests, and medical imaging made necessary by your medical condition independent of your participation in the clinical trial, are often not covered by the research sponsor. Third-party health insurance may pay for some or all of these costs, but their obligation to do so varies among insurance plans. Be aware that health care delivered in the context of a clinical trial will most often be considered "investigational." Investigational therapies are often excluded from coverage under medical plans. You should discuss the financial aspects of your participation in a clinical trial with both your physician and with a representative of your insurance plan.


Questions to Ask Your Doctor

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

What is the purpose of the study?
How long will I be in the study?
How many people will participate in the study?
In which phase of the study will I participate?
How often will I need to go to the hospital or clinic?
What tests will I need?
Will my medical records remain confidential?
Is there a chance that I will receive a placebo in the study?
Will I continue to see my own personal doctor?
Will there be any cost to me?
Will participating in the study affect my daily life?
What kind of long-term follow-up care is included in the study?
Will I learn the results of the study? If so, when?
What are the potential benefits and possible risks?


Clinical Trials

AML (Acute Myloid Leukemia):

  • Phase III  Evaluating Azacitidine: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Compare Efficacy and Safety of Oral Azacitidine Plus Best Supportive Care Versus Best Supportive Care as Maintenance Therapy in Subjects with Acute Myloid Leukemia in Complete Remission.

Biomarker Expression:

  • *Biomarker Registry Trial:  A Registry of Caris Target Now Test Results (Biomarker Expression Patterns) and Hematopoietic Diagnostics for Evaluation of Correlation with Clinical Outcomes for Cancer and Other Patients.

Breast:

  • Phase II Study Evaluating Herceptin: randomized phase II neoadjuvant trastuzumab and / or lapatinib plus chemotherapy (sequential FEC75 and paclitaxel) in women with ErbB2 (HER2) overexpressinginvasive breast cancer trial
  • Phase III study Neratinib Evaluation: A Phase III, randomized, open-label Versus Neratinib lapatinib plus capecitabine for the treatment of ErbB-2 positive metastatic or locally advanced breast cancer
  • Phase III trial evaluating pertuzumab: A phase III randomized, double-blind, controlled trial with placebo to evaluate the efficacy and safety of pertuzumab plus trastuzumab + docetaxel vs. Placebo + trastuzumab + docetaxel in HER2-positive breast cancer previously untreated metastatic
  • Bevacizumab Trial Assessment: a multicenter, international study open - label, two-arm, Phase III trial of Avastin in adjuvant "triple negative" breast cancer
  • Trial Evaluation Sunitinib: randomized phase III study of sunitinib in combination with capecitabine compared with capecitabine in breast cancer patients previously treated Or metastatic An international, randomized, double-blind, placebo-controlled, Phase II AMG 479 with exemestane or fulvestrant in postmenopausal women with hormone receptor positive breast cancer locally advanced: • randomized studies evaluating AMG 479
  • Observational Study of Treatment Patterns: An observational study of treatment patterns of the results of safety metastatic or locally advanced breast cancer
  • Phase III study evaluating trastuzumab: a randomized, multicenter, phase III open-label study of the efficacy and safety of trastuzumab-MCC-DM1 VS. Lapatinib and capecitabine in patients with HER2-positive breast cancer locally advanced or metastatic who have received prior trastuzumab-based therapy
  • Trial Evaluation Zometa: a prospective, randomized, double-blind, stratified, multi-Trial 2 arms of the continued efficacy and safety of Zometa ® (every 4 weeks versus every 12 weeks) in patients with documented bone metastases from breast cancer
  • Trial bosutinib assessment letrozole versus letrozole alone: A phase II, randomized, open-label bosutinib administered in combination with letrozole versus letrozole alone as first-line therapy in postmenopausal women with locally advanced or metastatic ER + / PGR + / erbB2- Breast Cancer
  • Observational evaluate treatment patterns: An observational study of treatment patterns and safety outcomes for metastatic breast cancer or locally recurrent
  • ACE-011 Evaluation Trial: A phase II, double-blind, randomized, placebo-controlled study of ACE-011 for the treatment of chemotherapy-induced anemia in patients with metastatic breast cancer
  • Evaluation YM155 Trial: A Phase II, multicenter, open-label, randomized study of YM155 and docetaxel as first-line treatment in patients with HER2-negative metastatic breast cancer protocol for the Phase II of YM155
  • Lapatinib or Trastuzumab Trial Assessment: A, open, randomized, phase III taxane based chemotherapy with lapatinib and trastuzumab as first-line treatment for women with metastatic breast cancer HER2 / neu positive
  • Trial Evaluating T-DM1: A, 3 randomized, multicenter, phase III study to evaluate the efficacy and safety of T-DM1 combined with pertuzumab and T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab) arm, versus Herceptin plus-taxane combination as first-line therapy in progressive or recurrent breast cancer locally advanced or metastatic HER2-positive (MBC)
  • KW-2450 Evaluation Trial: A Phase 1/2 study to evaluate the safety, tolerability and preliminary efficacy of KW-2450 in combination with letrozole and lapatinib in patients with advanced or metastatic breast cancer whose tumors overexpress HER2
  • Observational study to evaluate treatment outcomes: observational cohort study of treatment patterns and outcomes in patients with HER2 positive (HER2 +) metastatic breast cancer
  • Assessment Test vs Neratinib lapatinib: A study of more Neratinib capecitabine versus lapatinib plus capecitabine in patients with HER2 + HER2 + metastatic cancer who have received two or more HER2-Directed regimes earlier in metastatic disease (NALA)
  • *Study Evaluating Neratinib Plus Capecitabine: Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients with HER2+ Metastatic Breast Cancer who have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting (NALA)
  • *Phase II Study of Enzalutamide with Trastuzumab: A Phase 2, Multicenter, open-label study to Assess the Efficacy and Safety of Enzalutamide with Trastuzumab in Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer
  • *Phase III Study of A Phase 3 Placebo-Controlled Trial of Carboplatin and Paclitaxel: Randomized, Placebo-Controlled Trial of Carboplatin and Paclitaxel With or Without the PARP Inhibitor Veliparib (ABT-888) in HER2-Negative Metastatic or Locally Advanced Unresectable BRCA-Associated Breast Cancer
  • *Phase II Study of Severity of Diarrhea in HER2+ Breast Cancer: A Phase II, An Open-Label Study to Characterize the Incidence and Severity of Diarrhea in Patients with Early-Stage HER2+ Breast Cancer Treated with Neratinib and Intensive Loperamide Prophylaxis

CLL:

  • Phase III study evaluating Revlimid vs Chlorambucil: A Phase III, multicenter, randomized, open, parallel-group study of the efficacy and safety of lenalidomide (Revlimid ®) versus chlorambucil as first-line treatment for elderly patients treated Mobile B- previously with chronic lymphocytic leukemia
  • *Phase II of Idelalisib and Rituximab:  A Phase 2, Single Arm Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Rituximab in Patients with Previously Untreated Chronic Lymphocytic Leukemia with 17p Deletion
  • *Phase III Study of Idelalisib:  A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Idelalisib in Combination with Obinutuzumab Compared to Chlorambucil in Combination with Obinutuzumab for Previously Untreated Chronic Lymphocytic Leukemia
  • *Phase II Study of Ublituximab: A Phase III Randomized, Study to Assess the Efficacy and Safety of Ublituximab in Combination with Ibrutinib Compared to Ibrutinib Alone, in Patients with Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

CML:

  • *Phase IIB Study of Dasatinib vs Imatinib: An open label, randomized (2:1) Phase 2B study of Dasatinib vs Imatinib in patients with chronic phase chronic myeloid leukemia who have not achieved an optimal response to 3 months of therapy with 400 mg imatinib

Colorectal:

  • Phase II study evaluating NKTR-102: a multicenter, open-label, randomized, phase II study to evaluate the efficacy and safety of NKTR-102 (PEG-irinotecan) versus irinotecan in patients with second line, irinotecan- Naïve, -mutante KRAS metastatic colorectal cancer (mCRC)
  • AMG 655 Trial Evaluation: Phase 1b / 2 Study of AMG 655 in combination with modified FOLFOX6 and bevacizumab for the first-line treatment of patients with metastatic colorectal cancer.
  • Observational Assessment Avastin plus chemotherapy: locally advanced observational study of Bevacizumab (Avastin) in combination with chemotherapy for the treatment of metastatic colorectal cancer or locally advanced unresectable or metastatic non-small cell lung metastatic (except predominant histology squamous) cells. Locally advanced or metastatic CRC unresectable locally advanced or metastatic NSCLC
  • Evaluation Bevacizumab Capecitabine Trial: A Randomized Phase 2 Study 7 on / 7 capecitabine in combination with irinotecan or oxaliplatin short duration and bevacizumab either short-lived as first-line treatment for patients with metastatic colorectal cancer
  • Trial Evaluation Epi proColon: Comparison of the performance of the Epi proColon test and fecal immunochemical Post colonoscopy in patients with colorectal cancer and colonoscopy in subjects Pre-Eligible Population Screening Guidance
  • Phase III study evaluating Print PGG and Erbitux: A Phase 3 open-label, randomized, multicenter Print PGG ® in combination with cetuximab (Erbitux ®) in patients with recurrent or progressive type KRAS colorectal cancer Wild
  • Phase III study evaluating MABp1:  A Phase III, multicenter, open, randomized, pivotal trial of Vera MABp1 ™ human monoclonal antibody in patients with metastatic colorectal cancer who are refractory to standard therapy

HCC:

  • Phase Ib/II Study of MSC2156119J: A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK of MSC2156119J as Monotherapy in Subjects with MET+ Advanced Hepatocellular Carcinoma with Child Pugh Class A Liver Function Who Have Failed Sorafenib Treatment.

Gastrointestinal:

  • Trial evaluating bevacizumab and capecitabine: a double-blind, randomized, multicenter Phase III study of Avastin in combination with capecitabine and cisplatin versus placebo in combination with capecitabine and cisplatin as first-line treatment in patients with advanced gastric cancer
  • An observational study of patients with GIST: A database of observation to obtain data on variations in the current diagnostic and therapeutic management of patients with GIST in a variety of practice areas
  • Trastuzumab Assessment Test: a randomized, open-label, multicenter Phase IIIb Comparison study of two dosage regimens Trastuzumab, each in combination with cisplatin / capecitabine chemotherapy as first-line treatment in patients with HER2-positive metastatic gastric or Gastro Junction Adenocarcinoma -esofágico who have not received prior treatment for metastatic disease

Head and Neck:

  • Cetuximab Trial Evaluation: a randomized, double-blind, Phase 2 study of cetuximab safety, ImClone against Boehringer Ingelheim With manufacturing processes, in combination with cisplatin or carboplatin and 5-fluorouracil in the first-line treatment of patients with recurrent locoregional and / or metastatic squamous cell carcinoma of head and neck
  • *Phase II Study of MEDI4736 Monotherapy: A multi-center, single-arm, global, Phase II study to determine the efficacy and safety of MEDI4736 monotherapy in the treatment of patients with recurrent or metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) who have progressed during or after treatment with a platinum-containing regimen for recurrent or metastatic disease.
  • *Phase II Study of MEDI4736: A Phase II, Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy, Tremelimumab Monotherapy, and MEDI4736 in Combination with Tremelimumab in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN).
  • *Study Evaluating MEDI4736: A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 Monotherapy and MEDI4736 in combination with Tremelimumab vs Standard of Care Therapy in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. 

Hepatocellar:

  • A Multicenter, Single Arm, Phase Ib/II Study to Evaluate Efficacy, Safety, and PK of MSC2156119J as Monotherapy in Subjects with MET+ Advanced Hepatocellular Carcinoma with Child Pugh Class A Liver Function Who Have Failed Sorafenib Treatment.

Leukemia / Lymphoma:

  • Evaluation Nimotuzumab Trial: A Phase IIb, randomized, double-blind, placebo-controlled, low-dose cytarabine and Lintuzumab In comparison with the low-dose cytarabine and placebo in patients 60 years of age and older with previously untreated AML

Lung:

  • Eerlotinib Evaluation Trial: A Phase III, multicenter, double-blind, placebo-controlled, randomized trial to evaluate the efficacy of Avastin in combination with Tarceva (erlotinib) compared with Tarceva alone for the treatment of metastatic non-small cell lung Advanced ( NSCLC) after failure of standard first-line chemotherapy
  • An observational study evaluated pemetrexed: Observational study to evaluate the impact of ethnicity in patients being treated with ALIMTA in second-line non-small cell lung cancer
  • Trial evaluating the long-term safety of darbepoetin alfa: a randomized, double-blind, placebo-controlled study to evaluate the long-term safety and efficacy of darbepoetin alfa administered 500 mg every 3 weeks (Q3W) in anemic subjects with advanced stage non-small lung cancer treated with multiple chemotherapy cycle
  • Trial Assessment Paclitaxel poliglumex / carboplatin vs paclitaxel / carboplatin: Paclitaxel poliglumex (CT-2103) / carboplatin versus paclitaxel / carboplatin for the treatment of advanced non-small without prior chemotherapy (NSCLC) in women with estradiol> 30 pg lung cancer / ml
  • Phase II Study Evaluating PF-00299804: Phase II, open-label trial of PF-00299804 in treating advanced lung adenocarcinoma in never or light former smokers
  • Evaluation ARQ197 Trial: A Randomized Phase 2 Study with or without erlotinib in previously treated patients ARQ197 w / locally advanced or metastatic NSCLC
    Non-small cell lung cancer locally advanced or metastatic (excluding predominant squamous cell histology) an observational study of Bevacizumab (Avastin) in combination with chemotherapy for the treatment of metastatic colorectal cancer or locally advanced unresectable: • observational study of Avastin .
  • Evaluation Phase II Trial of Temozolomide maintenance: A small non-randomized phase II lung maintenance temozolomide versus observation in response stable or Stage IIIB / IV cell cancer patients
  • Phase III study evaluating BIBF: multicenter, randomized, double-blind, Phase III to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed treatment compared with placebo plus standard pemetrexed in patients with stage IIIB / IV or recurrent non-small cell lung cancer after failure of first-line chemotherapy
  • Trial Evaluation farletuzumab: a randomized, double-blind, placebo-controlled study of the safety and efficacy of farletuzumab in combination with carboplatin and paclitaxel or docetaxel followed pemetrexed in patients not previously treated with chemotherapy Stage IV lung adenocarcinoma wild-type EGFR
  • Phase II Study of Bevacisumab: a controlled, double-blind, multicenter, randomized, phase II study of bevacizumab in stage small cell lung cancer previously untreated
  • Phase II study of BMS-734016: a randomized, double-blind, parallel, three-arm, multicenter Phase II trial evaluating the efficacy and safety of ipilimumab (BMS-734016) in combination with Taxol / Paraplatin (paclitaxel / carboplatin) compared to Taxol / Paraplatin alone in previously untreated subjects with lung cancer
  • Phase III trial evaluating sunitinib: Phase III randomized, double-blind, controlled study of efficacy and safety of sunitinib in patients with non small cell lung cancer advanced / metastatic cells treated with erlotinib or SUTENT Trial
  • Test Phase III evaluation Stimuvax: Phase III, randomized, placebo-controlled, double-blind cancer vaccine "Stimuvax (L-BLP25 or BLP25 liposome vaccine) in patients with NSCLC with unresectable stage III disease" or START Trial
  • Trial Evaluation TLK199: 2 randomized phase Ezatiostat Hydrochloride (TELINTRA TLK199 tablets) for the treatment of chemotherapy-induced neutropenia in cancer patients with non-small study cell lung locally advanced or metastatic receiving first-line chemotherapy
  • Phase II trial of PF-00299804: A randomized phase 2 trial PF-00299804 Versus erlotinib for the treatment of metastatic non-small cell lung Advanced after failure of at least one prior chemotherapy regimen
  • Phase IIIb study of erlotinib: a randomized, double-blind, placebo-controlled, Phase IIIb trial comparing bevacizumab therapy with or without erlotinib After completion of chemotherapy with bevacizumab for the first-line treatment of Non-squamous non- small cell locally advanced or metastatic cell lung cancer
  • Trial Evaluation Bavituximab: A, open, randomized, phase 2 trial of paclitaxel / carboplatin with or without Bavituximab in patients previously untreated NSCLC no locally advanced or metastatic squamous
  • BIBW 2992 Evaluation Trial: Lung 3, A, open, randomized, phase III study of BIBW 2992 compared with chemotherapy as first-line treatment for patients with stage IIIB or IV lung adenocarcinoma Hosting an activating EGFR mutation
  • Trial Evaluation Darbepoetin Alfa: A randomized, double-blind, placebo-controlled study to evaluate the long-term safety and efficacy of darbepoetin alfa administered 500 mg every 3 weeks (Q3W) stadium in anemic patients with non-small lung cancer Advance cells that receive multiple chemotherapy cycle
  • Trial Evaluation Bavituximab and docetaxel: A random phase, double-blind, placebo-controlled 2 Trial Bavituximab plus docetaxel in previously treated patients with locally advanced or metastatic non-squamous
  • Trial Evaluation Bavituximab and docetaxel: Phase 2, double-blind, placebo-controlled IPI-504 and docetaxel in previously treated patients with non-small stage IIIB or IV lung cancer cells
  • Trial Evaluation HSP90: AT13387 HSP90 inhibitor alone and in combination with crizotinib in the treatment of non-small cell lung cancer (NSCLC)
  • Test Lenvatinib Evaluation: a multicenter, open-label Phase 2 study of the safety and activity of Lenvatinib (E7080) in patients with adenocarcinoma KIF5B-RET-positive lung
  • Test MO22097 Assessment: An open label, randomized, phase IIIb trial evaluation of the efficacy and safety of the Standard of Care + / - Avastin treatment continues beyond disease progression in patients with non-squamous non-small lung cancer advanced (NSCLC) After first-line treatment with Avastin plus chemotherapy has Douublet A Platinum (MO22097)
  • Test Evaluating BIBW 2992: A stamp expanded access program open afatinib (BIBW 2992) for patients with NSCLC locally advanced or metastatic (NSCLC) harboring the EGFR mutation (s)
  • Phase IB Study of Erlotinib and Momelotinib: A Phase 1b Study of Erlotinib and Momelotinib for the Treatment of Epidermal growth Factor Receptor (EGFR) Mutated EGFR Tyrosine Kinase Inhibitor (TKI) Naïve Metastatic Non-Small Cell Lung Cancer
  • *Phase II Study of CO-1686 or Erlotinib: A Randomized, Open-Label, Phase II Study of CO-1686 or Erlotinib as First-Line Treatment of Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer
  • Phase II Trial Comparing Veliparib and Standard Chemotherapy: A Randomized, Open-Label, Multicenter, Phase 2 Trial Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Subjects Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers 
  • *Phase II Sudy of Ruxolitinib or Placebo A Randomized, Double-Blind Phase 2 Study of Ruxolitinib or Placebo in Combination With Pemetrexed/Cisplatin and Pemetrexed Maintenance for Initial Treatment of Subjects With Nonsquamous Non-Small Cell Lung Cancer That Is Stage IIIB, Stage IV, or Recurrent.
  • *Phase III Study of Oral Rociletinib and Cytotoxic Chemotherapy A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients with Mutant EGFR Non-small Cell Lung Cancer (NSCLC) after Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy
  • *Phase III Trial of BI 695502: A multicenter, randomized, double-blind Phase III trial to evaluate efficacy and safety of BI 695502 plus chemotherapy versus Avastin® plus chemotherapy in patients with advanced nonsquamous Non-Small Cell Lung Cancer.
  • *Phase II Trial of MGCD265: A Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene.

MDS:

  • Trial Evaluation TLK 199: 2 randomized phase study comparing two doses lists Ezatiostat Hydrochloride (TELINTRA, TLK199 Tablets) in low to intermediate-1 risk myelodysplastic syndrome (MDS)

Multiple Myeloma:

  • Trial Evaluating Zoledronic Acid Role: Directed Bone Marker Dosage Zometa (zoledronic acid) for the prevention of bone complications in patients with advanced multiple myeloma
  • Trial Evaluating Overall Survival with Zoledronic Acid: Factors determining overall survival in patients with multiple myeloma treated with Zoledronic Acid
  • A Phase II DVD: A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethasone (DVD) for newly diagnosed patients and multiple myeloma
  • Study Evaluation Phase IIIb Velcade: Randomized Phase IIIb of three treatment regimens in patients with previously untreated multiple myeloma who are not considered candidates for high-dose chemotherapy and autologous stem cell transplantation: VELCADE (bortezomib), thalidomide dexamethasone (VTD) versus VELCADE and dexamethasone (VD) compared to VELCADE, melphalan and prednisone (VMP)
  • Observational Study: Prospective Evaluation of Research in Multiple Myeloma: an observational evaluation (Preamble)
  • *Prospective Reseach Assessment in Multiple Myeloma: An Observational Evaluation
  • *Phase II Study of Pomalidomide: A Phase 2, Multicenter, Single-Arm, Open-Label Study of Pomalidomide in Combination with Low-Dose Dexamethasone in Subjects with Relapsed or Refractory Multiple Myeloma Following Lenalidomide Plus Dexamethasone in the Second-Line Setting
  • *Phase III Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone: A Phase 3 Study Comparing Daratumumab, Lenalidomide, and Dexamethasone (DRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects with Previously Untreated Multiple Myeloma who are Ineligible for High Dose Therapy.
  • *Phase IB Study of Carfilzomib: Phase 1b Study of Carfilzomib Administered Once Weekly in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma. 

Nausea and Vomiting:

  • Phase III Study Evaluating Netupitant: Multicenter phase III, randomized, double-blind, double-dummy, parallel group active in the efficacy and safety of oral Netupitant control is given in combination with palonosetron and dexamethasone compared to palonosetron and oral dexamethasone for the prevention of nausea and vomiting in cancer patients with chemotherapy emetogenic Receivingmoderately
  • Test Evaluation Chemothearpy Rolapitant Highly Emetogenic: A phase 3, multicenter, randomized, double-blind, active-controlled safety and efficacy of Rolapitant for the Prevention of chemotherapy nausea and vomiting induced by chemotherapy (CINV) in patients receiving highly emetogenic chemotherapy (HEC)
  • Test Evaluation Chemothearpy Rolapitant Moderately Emetogenic: A phase 3, multicenter, randomized, double-blind, active-controlled safety and efficacy of Rolapitant for the Prevention of chemotherapy nausea and vomiting induced by chemotherapy (CINV) in patients receiving moderately emetogenic chemotherapy (MEC)

Non-Hodgkins Lymphoma:

  • *Phase II Trial of Intravenous PI3K: Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY 80-6946 in Patients with Relapsed, Indolent or Aggressive Non-Hodgkin’s Lymphomas
  • *Phase II Study of Rituximab and Bendamustine: A Randomized, Open Label, Phase 2 Study of Rituximab and Bendamustine with or without Brentuximab Vedotin for Relapsed or Refractory CD30-Positive Diffuse Large B-Cell Lymphoma.

Ovarian:

  • Trial Evaluating TXA127: Phase IIb study evaluate the safety and efficacy of TXA127 in reducing the incidence and severity of thrombocytopenia in patients receiving combination therapy of gemcitabine and platinum per ovary, fallopian tube or peritoneal carcinoma
  • Study Phase II Evaluating of Liposomal Doxorubicin: randomized phase II trial Investigate liposomal doxorubicin with or without anti-derived growth factor platelet receptor alpha (PDGFR) monoclonal antibody IMC-3G3
  • Evaluation Trial Doxorubicin Hydrochloride in Liposomes: An open-label randomized crossover bioequivalence study and safety of doxorubicin hydrochloride injection liposome formulations in patients with advanced ovarian carcinoma
  • HVAC Assessment Test: A double-blind, randomized, placebo-controlled HVAC (Augologous dendritic cells pulsed with recombinant human fusion protein [mucin 1-glutathione S-Transferqase] Along with rusty polymannose) as maintenance therapy in patients with epithelial ovarian Cancer (EOC) in complete remission after first-line chemotherapy
  • *Phase I and II Study of AL3818: A Phase 1/2a Evaluation of the Safety and Efficacy of AL3818 to Standard Platinum Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Cancer.  

Pancreatic:

  • Testing and evaluating gemcitabine Bavituximab: A, open, randomized, phase 2 trial of gemcitabine with or without Bavituximab in patients with pancreatic cancer in previously untreated stage IV
  • Phase II trial Ruxolitinib Evaluation: A Randomized Phase 2 Study of Efficacy and Safety Ruxolitinib in combination with capecitabine for patients with recurrent or refractory treatment of metastatic pancreatic cancer
  • KLT Test Evaluation: A randomized Security and exploratory efficacy study of Kanglaite injection Gemcitabine Plus (G + K) versus gemcitabine in patients with advanced pancreatic cancer
  • *Phase II Study of Glufosfamide: A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared with Fluorouracil (5-FU) in Patients with Metastatic Pancreatic Adenocarcinoma Previously Treated with Gemcitabine)
  • *Phase III Study of JAKI and II Inhibitor: Randomized, Double-Blind, Phase 3 Study of the JAK 1/2 Inhibitor, Ruxolitinib or Placebo in Combination with Capecitabine in Subjects with Advanced or Metastatic Adenocarcinoma of the Pancreas Who Have Failed or Are Intolerant to First-Line Chemotherapy (The JANUS 1 Study)
  • *Phase III Multicenter Study of PEGPH20: A Phase 2, Randomized, Multicenter Study of PEGPH20 (PEGylated Recombinant Human Hyaluronidase) Combined with nab-Paclitaxel Plus Gemcitabine Compared With nab-Paclitaxel Plus Gemcitabine in Subjects With Stage IV Previously Untreated Pancreatic Cancer
  • *Phase III Study of Maintenance Olaparib Monotherapy:  A Phase III, Randomized, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients with gBRCA Mutated Metastatic Pancreatic Cancer whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy 

Prostate:

  • Trial Evaluation ABR-215050: asymptomatic castration resistant prostate cancer (CRPC) metastatic - Phase II randomized, double-blind, placebo-controlled trial to determine the efficacy and safety of ABR-215050 in asymptomatic patients with metastatic prostate cancer resistant castration
  • Evaluation denosumab Trial: A Randomized, Double - Blind, Multicenter Study denosumab compared with zoledronic acid (Zometa) in the treatment of bone metastases in men with hormone-refractory prostate cancer
  • Observational study of docetaxel: Prospective observational study of Survival, treatment patterns, disease and economic outcomes in patients with refractory metastatic to cancer castration prostate (CRPC) with progression during or after first - line docetaxel - based regime
  • OGX-011-11 Test Evaluation: A randomized phase III study comparing standard first-line docetaxel / prednisone docetaxel / prednisone in combination with custirsen (OGX-011) in men with metastatic prostate cancer resistant to castration
  • Phase III Study to Evaluate DCVAC/PCa: Randomized, Double Blind, Multicenter, Parallel-Group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men with Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

Renal Cell Carcinoma:

  • Pazopanib Versus Sunitinib Trial Evaluation: A study of pazopanib versus sunitinib in the treatment of patients with renal cell carcinoma locally advanced and / or metastatic
  • Trial Evaluation Axitinib: Axitinib (AG-013736) as a second-line therapy for metastatic renal cell

Solid Tumors:

  • Trial Evaluation QT Corrected and Drugs: A phase Ib, single arm, open-label clinical trial to evaluate QTc and Drug - Interaction Drug Trastuzumab carboplatin in the presence of docetaxel in patients with HER2-positive metastatic or inoperable locally advanced cancer
  • Cetuximab Trial Evaluation: a study to assess the relationship between treatment with cetuximab and corrected QT (QTc) interval changes in patients with advanced solid tumors other than brain tumors A phase 1 study to evaluate the effect of NKTR-102 for injection (ETITRNOTECAN PEGOL) on the QT/QTC interval in patients with advanced OR metastatic solid tumors.
  • *Study Evaluating NKTR-102: An Open-label, multicenter, extension study of NKTR-102 in subjects previously enrolled in NKTR-102 Studies. 
  • A Phase I and II Study Evaluating MEDI4736: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors

Sarcoma:

  • Pivotal Trial Evaluating the Role of AP23573A: A pivotal trial to determine the efficacy and safety of AP23573 when given as maintenance treatment of patients with soft tissue or bone sarcomas metastatic

Specimen Collection: (Bone Marrow):

  • *An Observational Study to Collect Specimens for Future Scientific Research
  • *Specimen Collection from Individuals diagnosed with Late State (Stage III or IV) Non-Small Cell Lung Carcinoma 

 

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