IXEMPRA® (ixabepilone) | Combination Therapy: Study Design

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Study 046: A Phase III, open-label, multicenter, randomized trial of IXEMPRA combination therapy^1,4

375 patients received 40 mg/m² of ixabepilone intravenously over 3 hours every 3 weeks plus
1000 mg/m² of capecitabine orally twice daily x 14 days, followed by a 7-day rest period. 377 patients
received 1250 mg/m² of capecitabine orally twice daily x 14 days, followed by a 7-day rest period.

Patients received a median of 5 cycles and 4 cycles in the combination and single-treatment groups, respectively

Resistance criteria: Patients' tumors rapidly progressed or recurred on prior therapy
Tumors progressed within 3 months of the last anthracycline* dose in the metastatic setting –or– recurred within 6 months in the adjuvant or neoadjuvant setting
Tumors progressed within 4 months of the last taxane dose in the metastatic setting –or – recurred within 12 months in the adjuvant or neoadjuvant setting

*For anthracyclines, patients who received a minimum cumulative dose of 240 mg/m² of doxorubicin or 360 mg/m² of epirubicin were also eligible

End points

Primary—Progression-free survival determined by Independent Radiologic Review (IRR)

Secondary—Objective tumor response rate using Response Evaluation Criteria in Solid Tumors

Safety Information: Hepatic Impairment

Assessment of hepatic function is recommended before initiation of IXEMPRA and periodically thereafter
Patients with baseline AST or ALT >2.5 × ULN or bilirubin >1.5 × ULN experienced greater toxicity than patients with baseline AST or ALT ≤2.5 × ULN or bilirubin ≤1.5 × ULN when treated with IXEMPRA at 40 mg/m² in combination with capecitabine in breast cancer studies
In combination with capecitabine, the overall frequency of grade 3/4 adverse reactions, febrile neutropenia, serious adverse reactions, and toxicity-related deaths was greater

AST = aspartate aminotransferase; ALT = alanine aminotransferase; ULN = upper limit of normal.

Please see complete Important Safety Information, including Boxed WARNING regarding hepatic impairment.

IXEMPRA