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NCT00521404 · ClinicalTrials.gov registry record · Phase 2
Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
A Phase 2 study of Pancreatic Cancer, sponsored by Daiichi Sankyo.
- Completed
- Registry status
- Phase 2
- Development phase
- 65
- Enrollment target
- 12
- Study locations
NCT00521404: Completed Phase 2 study of Pancreatic Cancer, sponsored by Daiichi Sankyo.
NCT00521404 is a Phase 2 study of Pancreatic Cancer that has completed, run by Daiichi Sankyo. The registered enrollment target is 65 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (83% lower). The trial reports 12 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00521404, a Phase 2 study of Pancreatic Cancer, has completed, sponsored by Daiichi Sankyo.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 65 participants
- Enrollment target
- 12
- Study locations
Study Summary
Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
Primary Outcome
Progression-free survival rate (PFS) was defined as the time from the date of the first administration of the study drug (Day 1) to the date of the first objective documentation of disease progression or death resulting from any cause, whichever came first at 16 weeks post-treatment with CS-1008.
Conditions Studied
Interventions
- DRUG gemcitabine
- DRUG CS-1008 (humanized anti-DR5 antibody)
Study Locations (12)
Georgia
- - Atlanta
- Georgia Cancer Specialists - Tucker
Tennessee
- - Chattanooga
- - Nashville
Alabama
- - Birmingham
District of Columbia
- - Washington D.C.
Florida
- - Fort Myers
Illinois
- - Decatur
Minnesota
- - Minneapolis
Ohio
- - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2007-08-15 |
| Est. Completion | 2010-08-20 |
| Phase | Phase 2 |
What the finished NCT00521404 record still lists
NCT00521404 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (83% 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.
NCT00521404 lists 12 locations in 10 states (Georgia, Tennessee, Alabama).
Frequently Asked Questions
What is clinical trial NCT00521404 about?
NCT00521404 is a clinical study titled "Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer". Phase 2 study to determine the efficacy and safety of CS-1008 when given with gemcitabine to subjects with previously untreated and unresectable (unable to be surgically removed) or metastatic (spread to other areas beyond the pancreas) pancreatic cancer.
What is the current status of trial NCT00521404?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2007-08-15. Estimated completion is 2010-08-20.
What conditions does trial NCT00521404 study?
This clinical trial studies the following conditions: Pancreatic Cancer.
What interventions are being tested in trial NCT00521404?
The interventions under investigation include: gemcitabine (DRUG), CS-1008 (humanized anti-DR5 antibody) (DRUG).
Who is sponsoring clinical trial NCT00521404?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00521404 being conducted?
This trial has 12 study locations across Alabama, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00521404's enrollment target sits among peer trials
65 135th of 278 higher than 143 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.
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