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NCT00398086 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT00398086: Completed Phase 1 study, sponsored by Celgene.
NCT00398086 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00398086, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as one or more of the following toxicities related to study drug during Cycle 1, according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), Version 3: * Grade 4 neutropenia lasting \>3 days in the absence of growth factor support; * Grade 4 neutropenia associated with fever \>38.5°C; * Any other Grade 4 hematological toxicity; * Grade 3 thrombocytopenia with hemorrhage; * Grade 3 or 4 nausea, vomiting or diarrh
Interventions
- DRUG Gemcitabine
- DRUG Albumin-bound paclitaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2006-11-01 |
| Est. Completion | 2010-12-01 |
| Phase | Phase 1 |
What the finished NCT00398086 record still lists
NCT00398086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT00398086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00398086 about?
NCT00398086 is a clinical study titled "Gemcitabine Plus Albumin-bound Paclitaxel In Patients With Advanced Metastatic Pancreatic Cancer". To determine the maximum tolerated dose and dose-limiting toxicity of Gemcitabine plus Albumin-bound paclitaxel (ABI-007) in patients with advanced metastatic pancreatic cancer.
What is the current status of trial NCT00398086?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2006-11-01. Estimated completion is 2010-12-01.
What interventions are being tested in trial NCT00398086?
The interventions under investigation include: Gemcitabine (DRUG), Albumin-bound paclitaxel (DRUG).
Who is sponsoring clinical trial NCT00398086?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00398086's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 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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