A phase I study of ixabepilone combined with dasatinib in patients with solid tumors.

• DOI: 10.1200/jco.2010.28.15_suppl.e13514
• Publication Date: 2017-02-23T21:41:10Z
• Authors: C. C. Kaiser; D. J. Perry; A. S. Zimmer; J. W. Patterson; S. M. Swain
• Keywords: Ixabepilone; Tolerability

e13514 Background: Dasatinib is a small molecule inhibitor of multiple oncogenic tyrosine kinase families, including SRC. Ixabepilone novel microtubule-stabilizing epothilone that has shown clinical activity in solid tumors. Preclinical data shows synergy between SRC inhibitors and agents. This phase I study evaluated the safety tolerability ixabepilone dasatinib patients with advanced Methods: Standard eligibility criteria cycle 1 dose-limiting toxicity (DLT) definitions were used. (Ixa) was administered IV every 3 weeks over hours (Das) orally once daily. Dose escalation described Table. Results: Eleven pts (dose level 1, pts; dose 2, 6 3, 2 pts) have been enrolled; 8 female; tumor types: breast (4), colon (3), gastric (1), head neck pancreas renal cell (1); median age 56; 4 cycles (range: 1-6). One pt developed at (Gr neutropenia, Gr febrile diarrhea, nausea). diarrhea). A second required reductions after QTc prolongation) creatinine). Accrual to halted though maximum tolerated not reached. Two (head neck, pancreatic cancer) had unconfirmed partial response (stable disease), stable disease, progressive disease. Median duration disease for 95 days (range 49-126). Conclusions: The recommended II 40 mg/m2 100 mg being expanded by an additional 9 obtain further pharmacokinetic data. (Clinicaltrials.gov Identifier: NCT00717704) Ixa (mg/m2/d) Das (mg QD) Total no. No. DLT/total Nature DLT 30 11 0/3 23 1/6 nausea 150 1/2 diarrhea Author Disclosure Employment or Leadership Position Consultant Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bristol-Myers Squibb