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To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ixabepilone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixabepilone | Drug | Lyophilized and solvent, IV, 10-50 mg/m² |
|
| Measure | Description | Time Frame |
|---|---|---|
| Provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163107) and are benefiting from continuation on therapy with Ixabepilone as determined by the treating investigator | 21-day cycles until documented disease progression or unacceptable toxicity | |
| To evaluate the frequency and the severity of observed adverse reactions in treated patients, graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 | 21-day cycles until documented disease progression or unacceptable toxicity |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objectives will be assessed by combining data with the previous Phase II study CA163107 | 21-day cycles until documented disease progression or unacceptable toxicity | |
| To evaluate the antitumor response according to the RECIST criteria | 21-day cycles until documented disease progression or unacceptable toxicity |
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Inclusion Criteria:
Exclusion 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 | Nagoya | Aichi-ken | 464-8681 | Japan | ||
| Local Institution |
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| To evaluate the duration of achieved responses | 21-day cycles until documented disease progression or unacceptable toxicity |
| To evaluate time to progression (TTP) | 21-day cycles until documented disease progression or unacceptable toxicity |
| Kashiwa-Shi |
| Chiba |
| 277-0882 |
| Japan |
| Local Institution | Fukuoka | Fukuoka | Japan |
| Local Institution | Matabashi-Shi | Gunma | 371-8511 | Japan |
| Local Institution | Kagoshima | Kagoshima-ken | 892-0833 | Japan |
| Local Institution | Isehara-Shi | Kanagawa | 259-1193 | Japan |
| Local Institution | Niigata | Niigata | 951-8566 | Japan |
| Local Institution | Iruma-Gun | Saitama | 350-0495 | Japan |
| Local Institution | Saitama | Saitama | Japan |
| Local Institution | Utsunomiya | Tochigi | 320-0834 | Japan |
| Local Institution | Bunkyo-Ku | Tokyo | 113-8677 | Japan |
| Local Institution | Chuo-Ku | Tokyo | 104-0045 | Japan |
| Local Institution | Tokyo | Tokyo | Japan |
| Local Institution | Toshima-Ku | Tokyo | 170-8455 | Japan |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C430592 | ixabepilone |
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