A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects

Phase 1 Completed 51 enrolled AbbVie

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a three arm study to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with erlotinib (Arm A), to determine the maximum tolerated dose (MTD) of ABT-263 when administered in combination with irinotecan (Arm B), and to evaluate safety of ABT-263 monotherapy (Arm C).

Timeline

Start: 2009-10
Primary completion: 2013-06
Completion: 2013-06

Publications

Results Tolcher AW, LoRusso P, Arzt J, Busman TA, Lian G, Rudersdorf NS, Vanderwal CA, Kirschbrown W, Holen KD, Rosen LS. Safety, efficacy, and pharmacokinetics of navitoclax (ABT-263) in combination with erlotinib in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Nov;76(5):1025-32. doi: 10.1007/s00280-015-2883-8. Epub 2015 Sep 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Navitoclax	Small molecule	150 mg	Oral
Background	Erlotinib	Small molecule	150 mg	Oral
Background	Irinotecan	Small molecule	75 mg/m2	Intravenous
Background	Irinotecan	Small molecule	180 mg/m2	Intravenous

A Study Evaluating ABT-263 With Erlotinib, ABT-263 With Irinotecan, and ABT-263 Monotherapy in Cancer Subjects

Summary

Timeline

Publications

Drugs

Indications