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Rollover Study of Weekly Paclitaxel in Esophageal Cancer
NCT00971841Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2008
- Primary completion
- Apr 2012
- Sponsor
- Bristol Myers Squibb
- Modality
- Small Molecules
- Drugs
- paclitaxel
- Conditions
- esophageal cancer
01
Overview
Phase 2, open-label, single-arm trial of paclitaxel in esophageal cancer, sponsored by Bristol Myers Squibb. Primary endpoint: Number of Adverse Events (AEs) Per Participant. Started Mar 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Paclitaxel
Paclitaxel IV infusion weekly for 6 weeks followed by 1 week rest.
03
Who it enrols
Subjects with advanced or recurrent esophageal cancer who have completed the previous late Phase 2 study (CA139-540) and for whom continued therapy with paclitaxel would be beneficial.
04
Endpoints
Primary
Number of Adverse Events (AEs) Per Participant
Secondary
Number of Participants With Complete Response to Tumor
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