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NCT00667147 · ClinicalTrials.gov registry record · Phase 1
Phase I Abraxane Weekly and Three Weekly Schedule With Vandetanib
A Phase 1 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT00667147: Completed Phase 1 study, sponsored by University of Southern California.
NCT00667147 is a Phase 1 study that has completed, run by University of Southern California. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00667147, a Phase 1 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima and ZD6474). Abraxane has been approved by the Food and Drug Administration (FDA), for the treatment of breast cancer. Vandetanib is an experimental drug and has not been approved by the FDA for the treatment of any condition. Vandetanib has shrunk some non-small cell lung cancer, prostate cancer and thyroid cancer in some studies in humans. This combination of drugs is not approved for the treatment of any condition by the FDA. This study is being done in two phases. The first phase of the trial has two main objectives: 1) To find the highest daily dose of vandetanib that can be given safely with once weekly Abraxane and 2) To find the highest daily dose of vandetanib that can be given safely with Abraxane given every three weeks. Participants will be randomly assigned (like flipping a coin) to receive Abraxane weekly (Arm A) or once every three weeks (Arm B). The dose of Abraxane given will remain the same for the whole study - 100 mg/m2 when given weekly and 260 mg/m2 when given every three weeks. Participants will be entered onto each arm of the study in groups of three, and higher doses of vandetanib will be given each group of participants. The increase of vandetanib will stop once more than one participant has serious side effects. The highest dose of vandetanib that can be given with Abraxane (without serious side effects) in each Arm will be called the pilot dose. In the second phase of the study twenty participants will be randomly assigned to Arm A or Arm B and receive the pilot dose of vandetanib that was reached in the first phase of the study. The purpose of the second phase of the study is to see how many tumors shrink when participants receive the pilot dose of the drug combination on each Arm, as well as to gather more information about the side effects.
Interventions
- DRUG Weekly Abraxane and Daily Vandetanib
- DRUG Abraxane every three weeks and daily vandetanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2008-03 |
| Est. Completion | 2014-06 |
| Phase | Phase 1 |
What the finished NCT00667147 record still lists
NCT00667147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Weekly Abraxane and Daily Vandetanib is the first listed.
NCT00667147 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00667147 about?
NCT00667147 is a clinical study titled "Phase I Abraxane Weekly and Three Weekly Schedule With Vandetanib". This study uses the drugs Abraxane (also called ABI-007) and Vandetanib (also called Zactima and ZD6474). Abraxane has been approved by the Food and Drug Administration (FDA), for the treatment of breast cancer. Vandetanib is an experimental drug and has not been approved by the FDA for the treatmen...
What is the current status of trial NCT00667147?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2008-03. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00667147?
The interventions under investigation include: Weekly Abraxane and Daily Vandetanib (DRUG), Abraxane every three weeks and daily vandetanib (DRUG).
Who is sponsoring clinical trial NCT00667147?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00667147's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 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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