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NCT00379639 · ClinicalTrials.gov registry record · Phase 1
A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors
A Phase 1 study of Pancreatic Cancer, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT00379639: Completed Phase 1 study of Pancreatic Cancer, sponsored by Celgene.
NCT00379639 is a Phase 1 study of Pancreatic Cancer that has completed, run by Celgene. The registered enrollment target is 36 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00379639, a Phase 1 study of Pancreatic Cancer, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.
Primary Outcome
Toxicities were assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), V 3.0. A DLT was one of the following, if considered at least possibly related to study treatment: Grade 4 neutropenia for ≥5 days or febrile neutropenia; Grade 4 thrombocytopenia or need for a platelet transfusion; ≥ Grade 3 nausea and/or emesis despite using optimal antiemetic therapy; ≥ Grade 3 diarrhea despite using maximal supportive therapy; Any clinically signif
Conditions Studied
Interventions
- DRUG Gemcitabine
- DRUG Romidepsin
Study Locations (1)
Tennessee
- Sarah Cannon Research Institute - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2006-07-01 |
| Est. Completion | 2008-07-01 |
| Phase | Phase 1 |
What the finished NCT00379639 record still lists
NCT00379639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Pancreatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which Gemcitabine is the first listed.
NCT00379639 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT00379639 about?
NCT00379639 is a clinical study titled "A Study of Romidepsin (Depsipeptide) in Combination With Gemcitabine in Patients With Pancreatic and Other Advanced Solid Tumors". This was a phase I dose escalation trial designed to determine the maximum tolerated dose (MTD) for the combination of romidepsin (depsipeptide) and gemcitabine. The study was originally planned as a Phase I/II; however only Phase I of the study was conducted.
What is the current status of trial NCT00379639?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2006-07-01. Estimated completion is 2008-07-01.
What conditions does trial NCT00379639 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT00379639?
The interventions under investigation include: Gemcitabine (DRUG), Romidepsin (DRUG).
Who is sponsoring clinical trial NCT00379639?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00379639 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pancreatic Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00379639's enrollment target sits among peer trials
36 179th of 278 higher than 98 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer 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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