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NCT00702923 · ClinicalTrials.gov registry record · Phase 1
CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer
A Phase 1 study, sponsored by University of Wisconsin, Madison.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00702923 is a Phase 1 study that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 12 participants.
The verdict
NCT00702923, a Phase 1 study, was terminated before completion, sponsored by University of Wisconsin, Madison.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpoints will be to determine whether prostate associated immune responses are seen, and whether treatment is associated with an increase in PSA doubling time and PSA recurrence at one year, as markers of clinical activity. Cohorts of six patients will be treated in each dose level. The investigators hypothesize that short-term androgen deprivation therapy will elicit prostate cancer-associated T-cell mediated tissue destruction that can be augmented with a monoclonal antibody blocking CTLA-4, and that this will have therapeutic benefit in patients with recurrent prostate cancer.
Interventions
- DRUG Bicalutamide and CP-675,206 (Tremelimumab)
- DRUG Bicalutamide, CP-675,206 (tremelimumab)
- DRUG Bicalutamide, CP-675,206 (Tremelimumab)
- DRUG Bicalutamide, CP-675,206
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2008-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00702923
The ClinicalTrials.gov registry entry for NCT00702923 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Bicalutamide and CP-675,206 (Tremelimumab) is the first listed.
NCT00702923 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00702923 about?
NCT00702923 is a clinical study titled "CP-675,206 in Combination With Short Term Androgen Deprivation in Patients With Stage D0 Prostate Cancer". The current protocol will evaluate the safety of combining treatment with bicalutamide(Casodex) and CP-675,206 (anti-CTLA-4 monoclonal antibody) in patients with PSA-recurrent non-metastatic (stage D0) prostate cancer. This is a dose escalation study with safety the primary endpoint. Secondary endpo...
What is the current status of trial NCT00702923?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2008-07. Estimated completion is 2013-03.
What interventions are being tested in trial NCT00702923?
The interventions under investigation include: Bicalutamide and CP-675,206 (Tremelimumab) (DRUG), Bicalutamide, CP-675,206 (tremelimumab) (DRUG), Bicalutamide, CP-675,206 (Tremelimumab) (DRUG), Bicalutamide, CP-675,206 (DRUG).
Who is sponsoring clinical trial NCT00702923?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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