Phase 2
Completed N=11
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Source: ClinicalTrials.gov NCT00971867 ↗Enrolled (actual)
11
Serious AEs
27.3%
Results posted
Apr 2022
Primary outcomePrimary: Number of Participants With SAEs — 3 Number of Participants
Summary
The purpose of this study is to provide access to paclitaxel therapy to subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator, and to evaluate the frequency and the severity of observed adverse reactions in treated subjects
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With SAEs |
3 | — |
| PRIMARY Number of Participants With Adverse Events Leading to Discontinuation |
5 | — |
| PRIMARY Number of Participants With Adverse Events |
11 | — |
| PRIMARY Number of Participants With Laboratory Abnormalities |
11 | — |
| PRIMARY Number of Participants With Drug Related Laboratory Abnormalities |
11 | — |
| SECONDARY Number of Participants With Best Overall Response Per RECIST Criteria |
1; 6; 4 | — |
| SECONDARY Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer |
1; 9; 1 | — |
| SECONDARY Duration of Overall Response as Per RECIST Criteria |
222 | — |
| SECONDARY Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer |
269 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with advanced head and neck cancer who have completed the previous late phase 2 study (CA139-388) and should have continued therapy with paclitaxel as the discretion of the investigator
Data sourced from ClinicalTrials.gov (NCT00971867). 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.