Trial Outcomes & Findings for Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer (NCT NCT00971867)
NCT ID: NCT00971867
Last Updated: 2022-04-08
Results Overview
Number of Participants with SAEs
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From the first infusion to the completion of study. Approximately up to 28 months
Results posted on
2022-04-08
Participant Flow
11 Participants Treated
Participant milestones
| Measure |
Paclitaxel
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Paclitaxel
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Participant Withdrew Consent
|
1
|
|
Overall Study
Disease Progression
|
6
|
Baseline Characteristics
Rollover Study of Weekly Paclitaxel (BMS-181339) in Patients With Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From the first infusion to the completion of study. Approximately up to 28 monthsPopulation: All Treated Participants
Number of Participants with SAEs
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Number of Participants With SAEs
|
3 Number of Participants
|
PRIMARY outcome
Timeframe: From the first infusion to the completion of study. Approximately up to 28 monthsPopulation: All Treated Participants
Number of Participants with Adverse Events Leading to Discontinuation
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
|
5 Number of Participants
|
PRIMARY outcome
Timeframe: From the first infusion to the completion of study. Approximately up to 28 monthsPopulation: All Treated Participants
Number of Participants with Adverse Events
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Number of Participants With Adverse Events
|
11 Number of Participants
|
PRIMARY outcome
Timeframe: From the first infusion to the completion of study. Approximately up to 28 monthsPopulation: All Treated Participants
Number of Participants with Laboratory Abnormalities
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Number of Participants With Laboratory Abnormalities
|
11 Number of Participants
|
PRIMARY outcome
Timeframe: From the first infusion to the completion of study. Approximately up to 28 monthsPopulation: All Treated Participants
Number of Participants with Drug Related Laboratory Abnormalities
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Number of Participants With Drug Related Laboratory Abnormalities
|
11 Number of Participants
|
SECONDARY outcome
Timeframe: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 MonthsPopulation: All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539
Best overall response is represented by the number participants who have had complete response, partial response and have stable disease.
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Number of Participants With Best Overall Response Per RECIST Criteria
Complete Response (CR)
|
1 Number of Participants
|
|
Number of Participants With Best Overall Response Per RECIST Criteria
Partial Response (PR)
|
6 Number of Participants
|
|
Number of Participants With Best Overall Response Per RECIST Criteria
Stable Disease (SD)
|
4 Number of Participants
|
SECONDARY outcome
Timeframe: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 MonthsPopulation: All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Complete Response (CR)
|
1 Number of Participants
|
|
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Partial Response (PR)
|
9 Number of Participants
|
|
Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
Not Completed
|
1 Number of Participants
|
SECONDARY outcome
Timeframe: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 MonthsPopulation: All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539
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).
Outcome measures
| Measure |
Paclitaxel
n=11 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Duration of Overall Response as Per RECIST Criteria
|
222 Days
Interval 70.0 to 847.0
|
SECONDARY outcome
Timeframe: From the enrollment in CA139-388 (NCT00855764) study up to 904 days after the first infusion in CA139-388 study. Approximately up to 42 MonthsPopulation: All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539
Best overall response is represented by the number participants who have had complete response, partial response and not completed.
Outcome measures
| Measure |
Paclitaxel
n=10 Participants
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer
|
269 Days
Interval 140.0 to 904.0
|
Adverse Events
Paclitaxel
Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paclitaxel
n=11 participants at risk
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
9.1%
1/11 • Number of events 1 • From the first infusion to the completion of study. Approximately up to 28 months
|
|
Gastrointestinal disorders
Vomitting
|
9.1%
1/11 • Number of events 1 • From the first infusion to the completion of study. Approximately up to 28 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
1/11 • Number of events 1 • From the first infusion to the completion of study. Approximately up to 28 months
|
|
General disorders
Cancer Pain
|
9.1%
1/11 • Number of events 1 • From the first infusion to the completion of study. Approximately up to 28 months
|
Other adverse events
| Measure |
Paclitaxel
n=11 participants at risk
Each vial (16.7 mL) contains 100 mg
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
100.0%
11/11 • Number of events 11 • From the first infusion to the completion of study. Approximately up to 28 months
|
|
Nervous system disorders
Hypoesthesia
|
81.8%
9/11 • From the first infusion to the completion of study. Approximately up to 28 months
|
|
General disorders
Fatigue
|
63.6%
7/11 • From the first infusion to the completion of study. Approximately up to 28 months
|
|
General disorders
Weight Disorder
|
45.5%
5/11 • From the first infusion to the completion of study. Approximately up to 28 months
|
|
General disorders
Nail Disorder
|
45.5%
5/11 • From the first infusion to the completion of study. Approximately up to 28 months
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60