To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Lyophilized and solvent, IV, 10-50 mg/m²
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Kashiwa-Shi, Chiba, Japan
Local Institution
Fukuoka, Fukuoka, Japan
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
Time frame: 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
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
Secondary objectives will be assessed by combining data with the previous Phase II study CA163107
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the antitumor response according to the RECIST criteria
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate the duration of achieved responses
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
To evaluate time to progression (TTP)
Time frame: 21-day cycles until documented disease progression or unacceptable toxicity
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Local Institution
Matabashi-Shi, Gunma, Japan
Local Institution
Kagoshima, Kagoshima-ken, Japan
Local Institution
Isehara-Shi, Kanagawa, Japan
Local Institution
Niigata, Niigata, Japan
Local Institution
Iruma-Gun, Saitama, Japan
Local Institution
Saitama, Saitama, Japan
Local Institution
Utsunomiya, Tochigi, Japan
...and 4 more locations