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NCT00551096 · ClinicalTrials.gov registry record · Phase 1
Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors
A Phase 1 study of Pancreatic Cancer and Biliary Cancer, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT00551096: Completed Phase 1 study of Pancreatic Cancer and Biliary Cancer, sponsored by University of Colorado, Denver.
NCT00551096 is a Phase 1 study of Pancreatic Cancer and Biliary Cancer that has completed, run by University of Colorado, Denver. The registered enrollment target is 23 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00551096, a Phase 1 study of Pancreatic Cancer and Biliary Cancer, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Zactima will be used in this study to determine the highest dose that can be given safely as well as the side effects of Zactima when in combination with two FDA approved drugs; gemcitabine and capecitabine. This combination will be given to patients with advanced solid tumors. Once the highest dose of the combination has been determined, additional patients with biliary cancers (cholangiocarcinomas and gallbladder cancer) and locally advanced or metastatic pancreatic cancer will be treated at the highest determined dose for further studies.
Primary Outcome
To evaluate the safety profile and determine the MTD dose of ZACTIMA in combination with Gemcitabine and Capecitabine in patients with advanced malignancies. Toxicity will be graded per Common Toxicity Criteria for Adverse Effects (CTCAE) Version 3.0 and adverse event reporting for this study will be performed via Adverse Event Expedited Reporting System (AdEERS). All patients who receive any amount of the study drug will be evaluable for toxicity.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Gemcitabine
- DRUG ZD6474
Study Locations (1)
Colorado
- University of Colorado Denver - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2007-10 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT00551096 record still lists
NCT00551096 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 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.
NCT00551096 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT00551096 about?
NCT00551096 is a clinical study titled "Gemcitabine/Capecitabine/ZD6474 in Advanced Solid Tumors". Zactima will be used in this study to determine the highest dose that can be given safely as well as the side effects of Zactima when in combination with two FDA approved drugs; gemcitabine and capecitabine. This combination will be given to patients with advanced solid tumors. Once the highest dose...
What is the current status of trial NCT00551096?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2007-10. Estimated completion is 2013-05.
What conditions does trial NCT00551096 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Biliary Cancer, Malignant Solid Tumour.
What interventions are being tested in trial NCT00551096?
The interventions under investigation include: Capecitabine (DRUG), Gemcitabine (DRUG), ZD6474 (DRUG).
Who is sponsoring clinical trial NCT00551096?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00551096 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00551096's enrollment target sits among peer trials
23 220th of 278 higher than 57 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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