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NCT01498978 · ClinicalTrials.gov registry record · Phase 2
Ipilimumab in Combination With Androgen Suppression Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
A Phase 2 study, sponsored by OHSU Knight Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT01498978: Completed Phase 2 study, sponsored by OHSU Knight Cancer Institute.
NCT01498978 is a Phase 2 study that has completed, run by OHSU Knight Cancer Institute. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01498978, a Phase 2 study, has completed, sponsored by OHSU Knight Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase II trial studies how well ipilimumab works when given together with androgen suppression therapy in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some block the ability of tumors to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Androgen can cause the growth of prostate cancer. Androgen deprivation therapy may stop the adrenal glands from making androgen. Giving ipilimumab together with androgen suppression therapy may kill more tumor cells.
Primary Outcome
Undetectable PSA (prostate-specific antigen) defined as PSA ≤ 0.2 ng/mg after initiation of ipilimumab therapy. Provided with the exact 95% confidence interval. PSA response as recommended by the Prostate Cancer Clinical Trials Working Group (PCWG2) definitions. Percentage can take on values between 0% and 100%.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2012-02-06 |
| Est. Completion | 2019-01-19 |
| Phase | Phase 2 |
What the finished NCT01498978 record still lists
NCT01498978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which laboratory biomarker analysis is the first listed.
NCT01498978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01498978 about?
NCT01498978 is a clinical study titled "Ipilimumab in Combination With Androgen Suppression Therapy in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer". This phase II trial studies how well ipilimumab works when given together with androgen suppression therapy in treating patients with hormone-resistant prostate cancer that has spread to other parts of the body. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Som...
What is the current status of trial NCT01498978?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2012-02-06. Estimated completion is 2019-01-19.
What interventions are being tested in trial NCT01498978?
The interventions under investigation include: laboratory biomarker analysis (OTHER), ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01498978?
This trial is sponsored by OHSU Knight Cancer Institute, which has 211 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01498978's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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