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NCT01885949 · ClinicalTrials.gov registry record · Phase 2
Tivozanib + Enzalutamide in Adv Prostate Cancer
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT01885949: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01885949 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01885949, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
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
Primary Outcome
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.
Interventions
- DRUG Enzalutamide
- DRUG Tivozanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-09-03 |
| Est. Completion | 2024-05-23 |
| Phase | Phase 2 |
Why NCT01885949 stopped before completion
NCT01885949 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Enzalutamide is the first listed.
NCT01885949 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01885949 about?
NCT01885949 is a clinical study titled "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 t...
What is the current status of trial NCT01885949?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2013-09-03. Estimated completion is 2024-05-23.
What interventions are being tested in trial NCT01885949?
The interventions under investigation include: Enzalutamide (DRUG), Tivozanib (DRUG).
Who is sponsoring clinical trial NCT01885949?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01885949's enrollment target sits among peer trials
5 2000th of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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