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NCT00540579 · ClinicalTrials.gov registry record · Phase 1
CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas
A Phase 1 study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT00540579: Completed Phase 1 study, sponsored by SCRI Development Innovations.
NCT00540579 is a Phase 1 study that has completed, run by SCRI Development Innovations. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00540579, a Phase 1 study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study Summary
Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer is designed to determine the appropriate CC-4047 dose and regimen in combination with gemcitabine.
Primary Outcome
Unacceptable side effects or dose-limiting toxicities (DLTs) were defined as follows: * Inability to Complete cycle 1 of therapy due to drug-related toxicity. * \> Grade 3 non-hematological drug-related toxicity (excluding alopecia) despite optimal supportive care * Febrile neutropenia (absolute neutrophil count \[ANC\] \<1,000/μL and fever \>101° F (38.5° C)) * Grade 4 neutropenia that occurs prior to day 21. (Grade 4 neutropenia that occurs after day 21 but resolves within 7 days of the sched
Interventions
- DRUG Gemcitabine
- DRUG Pomalidomide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-01 |
| Phase | Phase 1 |
What the finished NCT00540579 record still lists
NCT00540579 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT00540579 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00540579 about?
NCT00540579 is a clinical study titled "CC-4047 With Gemcitabine for Untreated Advanced Carcinoma of the Pancreas". Because the activity of CC-4047 addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - CC-4047 has been selected for development as part of induction chemotherapy regimens for solid tumors. This study in pancreatic cancer is designed to deter...
What is the current status of trial NCT00540579?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2007-11. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00540579?
The interventions under investigation include: Gemcitabine (DRUG), Pomalidomide (DRUG).
Who is sponsoring clinical trial NCT00540579?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00540579's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 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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