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Open-label Study of CS-1008 for Subjects With Untreated and Unresectable Pancreatic Cancer
NCT00521404 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00521404
The ClinicalTrials.gov registry entry for NCT00521404 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00521404 reports 12 study locations spanning 10 distinct geographic areas — top geographies include Georgia, Tennessee, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00521404?
The interventions under investigation include: gemcitabine (DRUG), CS-1008 (humanized anti-DR5 antibody) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00521404?
This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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