Phase 2
Completed N=1
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Advanced or Recurrent Esophageal Cancer
Source: ClinicalTrials.gov NCT00971841 ↗Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcomePrimary: Number of Adverse Events (AEs) Per Participant — 32 adverse events
Summary
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced or recurrent esophageal cancer who have completed the previous Phase 2 study (CA139-540) and who should continue on therapy with paclitaxel as assessed by the treating investigator(s). To evaluate the severity of observed adverse reactions in treated subjects for assessment of long-term safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Events (AEs) Per Participant |
32 | — |
| SECONDARY Number of Participants With Complete Response to Tumor |
1 | — |
Eligibility Criteria
Subjects with advanced or recurrent esophageal cancer who have completed the previous late Phase 2 study (CA139-540) and for who continued therapy with paclitaxel would be beneficial as deemed by the investigator(s).
Data sourced from ClinicalTrials.gov (NCT00971841). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.