Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Drug: Paclitaxel

• Registration Number: NCT00971867
• Lead Sponsor: Bristol-Myers Squibb

Brief 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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2006-08-04
• Primary Completion: 2008-11-26
• Study Completion: 2008-11-26
• Study First Submitted: 2009-09-03
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Results First Submitted: 2021-10-19
• Status Verified: 2022-02
• Results First Submitted QC: 2022-02-16
• Last Update Submitted: 2022-02-16
• Results First Posted: 2022-04-08
• Last Update Posted: 2022-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paclitaxel	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	From the first infusion to the completion of study. Approximately up to 28 months	Number of Participants with Adverse Events
Number of Participants With Adverse Events Leading to Discontinuation	From the first infusion to the completion of study. Approximately up to 28 months	Number of Participants with Adverse Events Leading to Discontinuation
Number of Participants With Drug Related Laboratory Abnormalities	From the first infusion to the completion of study. Approximately up to 28 months	Number of Participants with Drug Related Laboratory Abnormalities
Number of Participants With SAEs	From the first infusion to the completion of study. Approximately up to 28 months	Number of Participants with SAEs
Number of Participants With Laboratory Abnormalities	From the first infusion to the completion of study. Approximately up to 28 months	Number of Participants with Laboratory Abnormalities

Secondary Outcome Measures

Name	Time	Method
Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer	From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months	Best overall response is represented by the number participants who have had complete response, partial response and not completed.
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer	From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months	Best overall response is represented by the number participants who have had complete response, partial response and not completed.
Number of Participants With Best Overall Response Per RECIST Criteria	From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months	Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.
Duration of Overall Response as Per RECIST Criteria	From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 Months	DOR is defined as the median time from the first date of Partial Response to the first date of Progressive Disease. Participants were evaluated for DOR in a separate study (NCT00971867).

Trial Locations

Locations (1)

Local Institution; 🇯🇵 Tochigi, Japan