A Phase 2 interventional study of Ixabepilone in Metastatic Breast Cancer, sponsored by R-Pharm. Completed at 14 sites in Japan. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2017-01-30.
Sponsored by R-Pharm · Phase 2, Interventional, and Treatment
To provide extended access to Ixabepilone therapy to subjects with metastatic breast cancer who have completed the previous Phase II study (CA163-107)
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →R-Pharm is the lead sponsor of 55 studies on the registry; 1 is open to participants now.
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Drug: Ixabepilone
Lyophilized and solvent, IV, 10-50 mg/m²
Also known as: Ixempra
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
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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