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An intersubject dose-escalation study of tesetaxel administered orally once every 3 weeks and once weekly for 3 consecutive weeks in patients with advanced or metastatic solid tumors.
Sub-category: Cytotoxic Chemotherapy
Category: Developmental Therapeutics - Clinical Pharmacology and Immunotherapy
Meeting: 2010 ASCO Annual Meeting
Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS159)
Abstract No: TPS159
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Session: Trials in Progress Poster Session
Type: Trials in Progress Poster Session
Time: Monday June 7, 8:00 AM to 12:00 PM
Location: S Hall A2
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Author(s): M. Beeram, S. C. Novick, A. Qureshi, A. Patnaik, K. Papadopoulos, A. W. Tolcher; The START Center for Cancer Care, San Antonio, TX; Genta Incorporated, Berkeley Heights, NJ
Abstract:
Background: Tesetaxel is an orally active tubulin-binding inhibitor that has completed multiple phase II trials. In multiple cancer cell lines and human tumor xenografts that overexpress P-glycoprotein, this activity substantially exceeds that of paclitaxel and docetaxel. In phase IIa studies, tesetaxel administered once every 3 weeks (27-35 mg/m2) has shown clinical activity in patients (pts) with advanced breast cancer and advanced gastric cancer (overall response rates of 38% and 20%, respectively) when administered as 2nd-line therapy. Myelosuppression (primarily neutropenia) was the most common adverse event. Pooled data from phase IIa studies showed that neutropenia was directly related to Cmax. Since taxanes as a class exhibit activity that can be schedule-related, we speculated that weekly dosing might show different results for safety, activity, and pharmacokinetics (PK). To test that assumption, we conducted an intersubject dose-escalation study to evaluate these parameters giving the drug once weekly for 3 consecutive weeks, and we compared those results to the every 3 week schedule. Methods: Pts with an advanced or metastatic solid tumor malignancy, ECOG PS ≤ 2, and adequate organ function are eligible to participate. Tesetaxel was initially given once every 3 weeks at doses ranging from 18 mg/m2 to 27 mg/m2, escalated in increments of 3 mg/m2. In the 2nd part of this ongoing study, tesetaxel is administered in 28-day cycles once weekly for 3 consecutive weeks beginning at a flat dose of 25 mg per cycle (administered as 10, 10, and 5 mg) and escalated in increments of 5 mg per total cycle dose to the MTD. A minimum of 2 treatment cycles are prescribed; absent progressive disease, pts may receive additional cycles. A total of 26 pts have been treated to date, with continuing accrual. Serial plasma samples have been collected for batch analysis of drug and metabolite concentrations. Comparative safety, efficacy, and PK from the 2 schedules will be presented to evaluate schedule-related effects of this novel agent.
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