Pharmacokinetic & Pharmacodynamic Study of ABT-751 With Carboplatin in Patients With Advanced Lung Cancer

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.

Timeline

Start

2004-09

Primary completion

2009-01

Completion

2009-01

Publications

• Ma T, Fuld AD, Rigas JR, Hagey AE, Gordon GB, Dmitrovsky E, Dragnev KH. A phase I trial and in vitro studies combining ABT-751 with carboplatin in previously treated non-small cell lung cancer patients. Chemotherapy. 2012;58(4):321-9. doi: 10.1159/000343165. Epub 2012 Nov 12.

Drugs

Indications