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NCT00868595 · ClinicalTrials.gov registry record · Phase 1
MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer
A Phase 1 study, sponsored by Bellicum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT00868595: Completed Phase 1 study, sponsored by Bellicum Pharmaceuticals.
NCT00868595 is a Phase 1 study that has completed, run by Bellicum Pharmaceuticals. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00868595, a Phase 1 study, has completed, sponsored by Bellicum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in patients with castrate resistant prostate cancer.
Primary Outcome
To determine the maximum tolerated dose (MTD) of BPX-101 and AP1903 when administered 24 hours apart
Interventions
- DRUG AP1903
- BIOLOGICAL BPX-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-04 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT00868595 record still lists
NCT00868595 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which AP1903 is the first listed.
NCT00868595 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00868595 about?
NCT00868595 is a clinical study titled "MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer". This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1), plus activating agent, AP1903, in patients with castrate resistant prost...
What is the current status of trial NCT00868595?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2009-04. Estimated completion is 2012-03.
What interventions are being tested in trial NCT00868595?
The interventions under investigation include: AP1903 (DRUG), BPX-101 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00868595?
This trial is sponsored by Bellicum Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00868595's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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