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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel | Drug | Solution, I.V., 100 mg/m2 Weekly for 6 of 7 weeks, Until disease progression or unacceptable toxicity became apparent |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Best Overall Response Per RECIST Criteria | Best overall response is represented by the number participants who have had complete response, partial response and have stable disease. | 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Kashiwa-shi | Chiba | 2778577 | Japan | ||
| Local Institution |
11 Participants Treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Paclitaxel | Each vial (16.7 mL) contains 100 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paclitaxel | Each vial (16.7 mL) contains 100 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With SAEs | Number of Participants with SAEs | All Treated Participants | Posted | Number | Number of Participants | From the first infusion to the completion of study. Approximately up to 28 months |
|
|
From the first infusion to the completion of study. Approximately up to 28 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paclitaxel | Each vial (16.7 mL) contains 100 mg | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials.@bms.com |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| C089957 | BMS 181339 |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer | Best overall response is represented by the number participants who have had complete response, partial response and not completed. | 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 | 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). | 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 | Best overall response is represented by the number participants who have had complete response, partial response and not completed. | 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 |
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Number of Participants With Adverse Events Leading to Discontinuation | Number of Participants with Adverse Events Leading to Discontinuation | All Treated Participants | Posted | Number | Number of Participants | From the first infusion to the completion of study. Approximately up to 28 months |
|
|
|
| Primary | Number of Participants With Adverse Events | Number of Participants with Adverse Events | All Treated Participants | Posted | Number | Number of Participants | From the first infusion to the completion of study. Approximately up to 28 months |
|
|
|
| Primary | Number of Participants With Laboratory Abnormalities | Number of Participants with Laboratory Abnormalities | All Treated Participants | Posted | Number | Number of Participants | From the first infusion to the completion of study. Approximately up to 28 months |
|
|
|
| Primary | Number of Participants With Drug Related Laboratory Abnormalities | Number of Participants with Drug Related Laboratory Abnormalities | All Treated Participants | Posted | Number | Number of Participants | From the first infusion to the completion of study. Approximately up to 28 months |
|
|
|
| Secondary | Number of Participants With Best Overall Response Per RECIST Criteria | Best overall response is represented by the number participants who have had complete response, partial response and have stable disease. | All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539 | Posted | Number | Number of Participants | 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 |
|
|
|
| Secondary | Number of Participants With Best Overall Response Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer | Best overall response is represented by the number participants who have had complete response, partial response and not completed. | All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539 | Posted | Number | Number of Participants | 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 |
|
|
|
| Secondary | Duration of Overall Response as Per RECIST Criteria | 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). | All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539 | Posted | Median | Full Range | Days | 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 |
|
|
|
| Secondary | Duration of Overall Response as Per the General Rules for Clinical and Pathological Studies of Head and Neck Cancer | Best overall response is represented by the number participants who have had complete response, partial response and not completed. | All Treated Participants in CA139-388 (NCT00855764) and who rolled over into CA139-539 | Posted | Median | Full Range | Days | 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 |
|
|
|
| 11 |
| 3 |
| 11 |
| 11 |
| 11 |
| Vomitting | Gastrointestinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Cancer Pain | General disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Hypoesthesia | Nervous system disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Weight Disorder | General disorders | MedDRA version 11.0 | Systematic Assessment |
|
| Nail Disorder | General disorders | MedDRA version 11.0 | Systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|