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NCT00880334 · ClinicalTrials.gov registry record · Phase 2
Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 149
- Enrollment target
NCT00880334: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT00880334 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 149 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00880334, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 149 participants
- Enrollment target
Study Summary
In this research study the investigators are looking to see if the combination of docetaxel plus Vandetanib is effective in the treatment of metastatic transitional cell carcinoma (TCC). Docetaxel is a chemotherapy drug that kills cancer cells that are dividing. It is widely used in TCC. Vandetanib is a drug that is believed to stop new blood vessels from forming around cancer cells. The combination of docetaxel and Vandetanib has been studied in people with lung cancer and found to be helpful in killing cancer cells. Thus, this study is looking at people with TCC, to see if the combination of docetaxel plus Vandetanib is better or worse then docetaxel alone.
Primary Outcome
PFS based on the Kaplan-Meier method is defined as the time between randomization and documented disease progression (PD) per RECIST 1.0 criteria or death, or is censored at time of last disease assessment. Per RECIST 1.0 for target lesions, PD is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or appearance of new lesions. For non-target lesions, PD is the appearance of one or more new lesions and/or unequivocal p
Interventions
- DRUG Placebo
- DRUG Docetaxel
- DRUG vandetanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2006-09 |
| Est. Completion | 2015-05 |
| Phase | Phase 2 |
What the finished NCT00880334 record still lists
NCT00880334 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00880334 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00880334 about?
NCT00880334 is a clinical study titled "Randomized Study of Docetaxel +/- Vandetanib in Metastatic TCC". In this research study the investigators are looking to see if the combination of docetaxel plus Vandetanib is effective in the treatment of metastatic transitional cell carcinoma (TCC). Docetaxel is a chemotherapy drug that kills cancer cells that are dividing. It is widely used in TCC. Vandetanib ...
What is the current status of trial NCT00880334?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 149 participants. The study started on 2006-09. Estimated completion is 2015-05.
What interventions are being tested in trial NCT00880334?
The interventions under investigation include: Placebo (DRUG), Docetaxel (DRUG), vandetanib (DRUG).
Who is sponsoring clinical trial NCT00880334?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00880334's enrollment target sits among peer trials
149 491st of 2000 higher than 1,510 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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