Tivozanib + Enzalutamide in Adv Prostate Cancer
This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether they work in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it, such as the safest dose to use and the side effects they may cause. It also means that the FDA has not yet approved the combination.
The two drugs being tested in this study are tivozanib and enzalutamide. Enzalutamide has been approved by the FDA for treatment of prostate cancer. On the other hand, tivozanib is still investigational, and has not been tested in a combination with enzalutamide before.
Enzalutamide is an androgen receptor antagonist (it blocks the activity of the male sex hormones). Prostate cancers are initially dependent on the male hormone testosterone for growth. Hormonal therapies that lower testosterone or block the ability of testosterone to act at the level of the prostate cancer are currently among the most effective treatments for prostate cancers taht have spread to other body organs (metastasized). The effectiveness of hormonal treatments, however, is not permanent, and over time many prostate cancers progress in spite of these treatments. Enzalutamide is a drug that has been proven to help delay the progression of advanced prostate cancer on average for about 8 months.
Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it needs to grow. The main goal of this study is to determine whether the combination of tivozanib and enzalutamide is more effective in delaying the progression of disease than when enzalutamide is given alone. This study will also determine whether treatment with the combination of the tivozanib and enzalutamide will have more side effects then treatment with enzalutamide alone.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase 2 Combination Trial of Tivozanib and Enzalutamide in Men With Advanced Prostate Cancer|
- Progression Free Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]The primary objective of this study will be to demonstrate an improvement in progression free survival in men with metastatic castration resistant prostate cancer (mCRPC) treated with tivozanib and enzalutamide.
- Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Safety and tolerability of tivozanib and enzalutamide will be assessed. The number of patients having grades 1-4 adverse events by NCI CTC version 4.0 will be recorded.
- Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]To estimate overall survival in patients treated with tivozanib and enzalutamide
- PSA Response rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]To evaluate PSA response rate
- Time to PSA Progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]The time to PSA progression (in months) will be evaluated in patients treated with enzalutamide and tivozanib
|Study Start Date:||June 2013|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: Experimental Treatment Arm
Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days
Other Name: AV-951Drug: Enzalutamide
Other Name: MDV-3100
Patients will be treated in treatment cycles of 28 days (4 weeks), during which time they will take tivozanib once a day for 21 days (3 weeks) followed by a one week break from treatment. The other medication, enzalutamide, will be taken every day throughout each cycle.
Patients will be given a Study Drug Administration Diary to keep a brief record of medication administration, and to record any side effects or symptoms.
Patients will be seen in the clinic at the beginning of each cycle (every 4 weeks). During each visit they will have the following procedures: medical history, vital sign measurements, complete physical examination, performance status, routine blood tests, urine sample, prostate specific antigen (PSA) test, assessment of tumor, review of study drug administration diary, and review of current medications.
About four weeks after stopping the study drug patients will be asked to return to the research clinic for a final study visit. The following procedures will be done: medical history, vital sign measurements, brief physical examination, electrocardiogram, review of other medications used since the last visit, routine blood tests, urine sample and a review of any changes in health.
|Contact: M. Dror Michaelson, MD, PhDfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Carol Gurski, RN 617-643-1770 email@example.com|
|Principal Investigator: M. Dror Michaelson, MD, PhD|
|Principal Investigator:||M. Dror Michaelson, MD, PhD||Massachusetts General Hospital|