Pharmacokinetic & Pharmacodynamic Study of ABT-751 With Carboplatin in Patients With Advanced Lung Cancer
Status:
Terminated
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
The primary objectives of this study are as follows:
• To determine the dose limiting toxicity (DLT) and the maximum tolerated dose (MTD) of
escalating ABT-751 in combination with fixed dose carboplatin in patients with advanced non
small cell lung cancer (NSCLC).
• To evaluate the efficacy of the combination with ABT-751 and carboplatin in patients with
advanced NSCLC
• To determine the median survival in the study population
Secondary Objectives
The secondary objectives are:
• To characterize the pharmacokinetic profile of ABT-751 given in combination with
carboplatin in a subset of patients, treated at the MTD or recommended doses for Phase 2.
• To determine the pharmacodynamics of ABT-751 as a single agent and the combination of
ABT-751 and carboplatin as evaluated by cell cycle analysis of buccal mucosa cells.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Dartmouth-Hitchcock Medical Center Konstantin Dragnev