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NCT01640665 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors
A Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01640665: Completed Phase 1 study, sponsored by Yale University.
NCT01640665 is a Phase 1 study that has completed, run by Yale University. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01640665, a Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to find the maximum tolerated dose of the combination of two drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug which is used to treat certain cancers. The drug Capecitabine is approved to treat patients with advanced breast cancer as well as early stage colon cancer.
Primary Outcome
Primary Objectives: * Safety * Determination of maximum tolerated dose
Interventions
- DRUG Capecitabine
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-07 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01640665 record still lists
NCT01640665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Capecitabine is the first listed.
NCT01640665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01640665 about?
NCT01640665 is a clinical study titled "Pilot Study of Sorafenib and Bi-weekly Capecitabine in Patients With Advanced Breast and Gastrointestinal Tumors". The purpose of this study is to find the maximum tolerated dose of the combination of two drugs. The two drugs are Sorafenib and Capecitabine. The drug Sorafenib is an approved drug which is used to treat certain cancers. The drug Capecitabine is approved to treat patients with advanced breast cance...
What is the current status of trial NCT01640665?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-07. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01640665?
The interventions under investigation include: Capecitabine (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01640665?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01640665's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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