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Clinical Trials

Clinical Trials
Today, we have better and more effective cancer drugs and therapies because of research. As a result of these newer treatments, survival rates have increased, quality of life has been improved and treatment side effects are fewer for thousands of people with cancer. Many of these drugs and therapies would not be available today if it were not for cancer research programs and cancer patients willing to participate in clinical trials. Some people feel that participating in a clinical trial gives them an opportunity to help other people with cancer through the knowledge gained from the study.


What is a clinical trial?
A clinical trial is a research study designed to answer one or more questions about how a certain drug, treatment or medical device affects a disease such as cancer. There are potential benefits to participating in a clinical trial, as well as potential risks. These benefits and risks are different for each clinical trial. You should discuss them with your own doctor, as well as with the clinical trial's research team.
 
Is participating in a clinical trial right for me?
The treatment you receive during a clinical trial may help you. Clinical trial participants receive either the most effective known treatment available or the new drug or treatment being considered. Newer therapies may lead to better results. On the other hand, they may not be any better, or even as good as, the standard treatment already available.
 
How do we enroll people in clinical trials?

Clinical trials usually evaluate very specific new treatments for very specific conditions. Therefore, they have very strict criteria about who is and who is not a candidate for each study. To ensure you have the broadest possible range of treatment options available, our research nurse will review your case during the diagnosis stage to see if you may match any of the criteria for the clinical trials in which Beaver Medical Group is participating.

If you are eligible for a current study, a research nurse will provide the details of the study to your oncologist, who will then ask you if you would be interested in learning more about participating in the clinical trial. Participating in a clinical trial will require some extra time on your part. The research team will want to monitor you closely during the trial and collect follow-up information. This care is in addition to the care you will continue to receive from your oncologist and medical team.

Contact the Clinical Research Coordinator at Beaver Medical Group, Oncology at (909) 425-3372 for information.


If you are interested in a clinical trial, here are the steps you will need to take to enroll in the study:


1. Receive a 15- to 20-page form on the study from your oncologist to take home and review. Informed consent is critical for a good clinical trial, so even if you are sure that you would like to do the study, you must take the information home and review it before you can sign up. The form, which is called an informed consent form, will include answers to the following questions:

a. What is the purpose of the clinical trial?
b. How long will the trial last?
c. What is required of you to participate in this study?
d. What treatments or drugs will you receive during the trial?
e. What treatments, tests and/or procedures will be required during the study? How many and how often?
f. Which treatments, tests, medications and/or procedures will be paid for?
g. What are the risks and benefits of participating in the study?
h. What treatment would be recommended for you if you do not participate in the trial?


2. Meet with the research nurse who will review the contents of the form with you again and show you the areas on the form  that you need to sign.


3. After the research nurse registers you with the study, you will be randomly selected for either a "control" group that receives the standard treatment or a "trial" group that receives the new treatment. Cancer patients are never given no treatment, like in the sugar-pill "placebo" groups in old science text books. Instead, the tested treatment is compared to current treatments. In some instances you will not know which group you are in, and neither will your doctors or the researchers, until the study is over.  In other instances you along with your doctors and the researchers will know exactly what you are receiving.


Participation in clinical trials is always voluntary.
You will never be enrolled in a clinical trial without your permission, and you can change your mind about participating in the clinical trial at any time after signing the informed consent forms. To stop participation in a study, simply talk to your research team.  Results can vary for individuals involved in a clinical trial.  Participants enrolled in clinical trials must have clear and realistic expectations based on their individual health status and diagnosis.

Current Trials – Oncology: Open to Enrollment

 1- HER2+ Adjuvant: PUMA-NER-6201- 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 https://clinicaltrials.gov/ct2/show/NCT02400476?term=PUMA-NER-6201&rank=1

2- HER2+ METASTATIC: PUMA-NER-1301- A 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). https://clinicaltrials.gov/ct2/show/NCT01808573?term=PUMA-NER-1301&rank=1

3- Triple Negative: IMpassion 130 (W029522)- A Phase III, Multicenter, Randomized, placebo-controlled study of MPDL3280A (anti?pd-l1 antibody) in combination with nab-paclitaxel compared with placebo with nab-paclitaxel for patients with previously untreated Metastatic Triple-Negative Breast Cancer. https://clinicaltrials.gov/ct2/show/NCT02425891?term=WO29522&rank=1

http://www.antipdl1clinicaltrials.com 


4- NSCLC Post Resection:  BR 31 ( Phase III NSCLC anti -pdL1)-  A Phase III Prospective Double Blind Placebo Controlled Randomized Study of adjuvant MEDI4736 in completely resected Non-Small Cell Lung Cancer.
 https://clinicaltrials.gov/ct2/show/NCT02273375?term=A+PHASE+III+PROSPECTIVE+DOUBLE+BLIND+PLACEBO+CONTROLLED+RANDOMIZED+STUDY+OF+ADJUVANT+MEDI4736+IN+COMPLETELY+RESECTED+NON-SMALL+CELL+LUNG+CANCER&rank=1

https://www.ctg.queensu.ca/public/lung/lung-disease-site

 

5- NON-SQUAMOUS NSCLC Metastatic 1st Line: Pfizer B7391003- A Phase III Randomized, Double-blind study of PF-06439535 plus paclitaxel-carboplatin and bevacizumab plus paclitaxel-carboplatin for the first-line treatment of patients with advanced Non-Squamous Non-Small Cell Lung Cancer. https://clinicaltrials.gov/ct2/show/NCT02364999?term=Pfizer+B7391003&rank=1

  

6- Maintanace Therapy After Initial Therapy: Millennium C1602_ Ixazomib- A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation https://clinicaltrials.gov/ct2/show/NCT02312258?term=A+Phase+3%2C+Randomized%2C+Placebo-Controlled%2C+Double-Blind+Study+of+Oral+Ixazomib+Maintenance+Therapy+After+Initial+Therapy+in+Patients+With+Newly+Diagnosed+Multiple+Myeloma+Not+Treated+With+Stem+Cell+Transplantation&rank=1

  

7- Observational any Patient with PV: Incyte-REVEAL-401- Prospective, non-interventional study of disease progression and treatment of patients with Polycythemia Vera in United States academic or community clinical practices. https://clinicaltrials.gov/ct2/show/NCT02252159?term=PROSPECTIVE%2C+NON-INTERVENTIONAL+STUDY+OF+DISEASE+PROGRESSION+AND+TREATMENT+OF+PATIENTS+WITH+POLYCYTHEMIA+VERA+IN+UNITED+STATES+ACADEMIC+OR+COMMUNITY+CLINICAL+PRACTICES&rank=1

http://www.revealpvstudy.com/

  

8- Observational  Study for Patients with Castration-Resistant Prostate Cancer: Astellas CRPC ONC- MA -1004- A Prospective Observational Cohort Study of Patients with Castration-Resistant Prostate Cancer (CRPC) in the United States https://clinicaltrials.gov/ct2/show/NCT02380274?term=ONC-MA-1004&rank=1

 

Current Trials - Oncology / Hematology: Closed to Enrollment

Observation patient after 6 months of Velcade therapy: Oncotherapeutics Vitamin D Study_X05392- Serum Vitamin D Levels and Peripheral Neuropathy among Multiple Myeloma Patients https://clinicaltrials.gov/ct2/show/NCT01697839?term=Oncotherapeutics+Vitamin+D+Study_X05392-&rank=1

NSCLC Adenocarcinoma Metastatic 2nd Line: BI1199.128_Lume Lung- Multicenter, Randomized, double-blind, phase iii trial to investigate the efficacy and safety of oral nintedanib plus docetaxel therapy compared to placebo plus therapy in patients with stage IIIb/Iv or recurrent, Adenocarcinoma Subtype Non-Small Cell Lung Cancer after failure of first line chemotherapy. https://clinicaltrials.gov/ct2/show/NCT02231164?term=Multicentre%2C+randomised%2C+double-blind%2C+Phase+III+trial+to+investigate+the+efficacy+and+safety+of+oral+nintedanib+plus+docetaxel+therapy+compared+to+placebo+plus+docetaxel+therapy+in+patients+with+stage+IIIB%2FIV+or+recurrent%2C+adenocarcinoma+subtype+non&rank=1

A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) (Shingles) and HZ-related Complications in Adult Participants With Solid Tumor or Hematologic Malignancy (V212-011) 

Symptom Burden and Quality of Life Outcomes in Advanced NSCLC Patients Treated in the Community Setting (Patients will complete questionnaires before each chemotherapy treatment and at each scheduled follow up for a year)

 Randomized Open-Label Study of INCB047986 in Subjects With Primary Myelodysplastic Syndrome (MDS) (Transfusion dependent, unlikely to respond to Erythropoiesis-Stimulating agents; ESA's)

 Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab in Subjects With Previously Untreated Chronic Lymphocytic Leukemia

 A Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer (Postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who have received nor prior therapy for advanced disease). Visit www.lee011.com for more information on this trial.