Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
1 other identifier
interventional
11
1 country
9
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 head-and-neck-cancer
Started Aug 2006
Shorter than P25 for phase_2 head-and-neck-cancer
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 4, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 26, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 26, 2008
CompletedFirst Submitted
Initial submission to the registry
September 3, 2009
CompletedFirst Posted
Study publicly available on registry
September 4, 2009
CompletedResults Posted
Study results publicly available
April 8, 2022
CompletedApril 8, 2022
February 1, 2022
2.3 years
September 3, 2009
October 19, 2021
February 16, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Number of Participants With SAEs
Number of Participants with SAEs
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 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
Number of Participants with Adverse Events
From the first infusion to the completion of study. Approximately up to 28 months
Number of Participants With Laboratory Abnormalities
Number of Participants with 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 Drug Related Laboratory Abnormalities
From the first infusion to the completion of study. Approximately up to 28 months
Secondary Outcomes (4)
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
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
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
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
Study Arms (1)
Paclitaxel
EXPERIMENTALInterventions
Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Local Institution
Kashiwa-shi, Chiba, 2778577, Japan
Local Institution
Matsuyama, Ehime, Japan
Local Institution
Kagoshima, Kagoshima-ken, 8900075, Japan
Local Institution
Yokohama, Kanagawa, 241-0815, Japan
Local Institution
Osaka, Osaka, 5458586, Japan
Local Institution
Sunto-gun, Shizuoka, 4118777, Japan
Local Institution
Meguro-ku, Tokyo, 1520021, Japan
Local Institution
Kanagawa, Japan
Local Institution
Tochigi, 329-0498, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2009
First Posted
September 4, 2009
Study Start
August 4, 2006
Primary Completion
November 26, 2008
Study Completion
November 26, 2008
Last Updated
April 8, 2022
Results First Posted
April 8, 2022
Record last verified: 2022-02