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NCT00796991 · ClinicalTrials.gov registry record · Phase 1
Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 72
- Enrollment target
NCT00796991: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT00796991 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 72 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00796991, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 72 participants
- Enrollment target
Study Summary
The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine
Primary Outcome
Cmax=micrograms per milliliter (µg/mL): drug concentration versus time for ipilimumab (Day 43) and paclitaxel, dacarbazine, and AIC (Days 1, 43). Ipilimumab determined from plasma by Enzyme-linked Immunosorbent Assay (ELISA); lower level of quantitation (LLOQ)=0.8 µg/mL; upper limit of quantitation (ULOQ)=25.6 µg/mL; Day 43=0 hour (h) predose, 1.5, 4.0, 24, 72, 168, 336, 504 h post dose; from Day 162 on every 12 weeks (Day 1 and 22= 0 h). Paclitaxel determined using liquid chromatography tandem
Interventions
- DRUG Carboplatin
- DRUG Ipilimumab
- DRUG Paclitaxel
- DRUG Dacarbazine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2009-02 |
| Est. Completion | 2012-10 |
| Phase | Phase 1 |
What the finished NCT00796991 record still lists
NCT00796991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 4 interventions - of which Carboplatin is the first listed.
NCT00796991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00796991 about?
NCT00796991 is a clinical study titled "Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine". The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine
What is the current status of trial NCT00796991?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 72 participants. The study started on 2009-02. Estimated completion is 2012-10.
What interventions are being tested in trial NCT00796991?
The interventions under investigation include: Carboplatin (DRUG), Ipilimumab (DRUG), Paclitaxel (DRUG), Dacarbazine (DRUG).
Who is sponsoring clinical trial NCT00796991?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00796991's enrollment target sits among peer trials
72 736th of 2000 higher than 1,254 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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