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NCT01377389 · ClinicalTrials.gov registry record · Phase 2
Ipilimumab + Androgen Depravation Therapy in Prostate Cancer
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01377389: Clinical Trial Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01377389 is a Phase 2 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01377389, a Phase 2 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if ipilimumab in combination with either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also want to learn if these drug combinations affect the body's immune system. The safety of these drug combinations will also be studied.
Primary Outcome
Anti-tumor activity assessed through serial PSA measurements (blood tests) at 7 months on treatment. Progression defined as two consecutive PSA values increasing by at least 20% or more from the lowest PSA value for each patient.
Interventions
- DRUG Ipilimumab
- DRUG Goserelin
- DRUG Degarelix
- DRUG Leuprolide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-06-17 |
| Est. Completion | 2017-04-07 |
| Phase | Phase 2 |
Why NCT01377389 stopped before completion
NCT01377389 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Ipilimumab is the first listed.
NCT01377389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01377389 about?
NCT01377389 is a clinical study titled "Ipilimumab + Androgen Depravation Therapy in Prostate Cancer". The goal of this clinical research study is to learn if ipilimumab in combination with either Lupron® (leuprolide), Zoladex® (goserelin), or Firmagon® (degarelix) can affect prostate-specific antigen (PSA) levels in patients with prostate cancer. Researchers also want to learn if these drug combinat...
What is the current status of trial NCT01377389?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-06-17. Estimated completion is 2017-04-07.
What interventions are being tested in trial NCT01377389?
The interventions under investigation include: Ipilimumab (DRUG), Goserelin (DRUG), Degarelix (DRUG), Leuprolide (DRUG).
Who is sponsoring clinical trial NCT01377389?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01377389's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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