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

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Non Small Cell Lung CancerLung Cancer
Interventions
DRUG

ABT-751 and Carboplatin

This primary objective of this Phase 1/2 study is to evaluate the DLT and MTD of escalating oral doses of ABT-751 given BID on Day 1 of each cycle for 7 days in combination with carboplatin given on a 21-day schedule. The carboplatin dose is fixed at AUC 6 and will be administered on Day 4 during the first cycle to facilitate the pharmacokinetic analysis. During the subsequent cycles both agents will be administered on Day 1. ABT-751 is administered at the following dose levels using the Simon rapid dose escalation model: 100, mg, 125 mg, 150 mg, 175 mg and 200 mg BID.

Trial Locations (1)

03756

Dartmouth-Hitchcock Medical Center, Lebanon

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott

INDUSTRY

lead

Konstantin Dragnev

OTHER

NCT00735878 - Pharmacokinetic & Pharmacodynamic Study of ABT-751 With Carboplatin in Patients With Advanced Lung Cancer | Biotech Hunter | Biotech Hunter