Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors

Phase 1 Completed 46 enrolled AbbVie Genentech, Inc. · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase 1 open-label study evaluating the safety of navitoclax (ABT-263) when combined with a standard regimen of gemcitabine in approximately 50 subjects with solid tumors and measurable disease.

Timeline

Start: 2009-09
Primary completion: 2011-11
Completion: 2011-11

Publications

Results Cleary JM, Lima CM, Hurwitz HI, Montero AJ, Franklin C, Yang J, Graham A, Busman T, Mabry M, Holen K, Shapiro GI, Uronis H. A phase I clinical trial of navitoclax, a targeted high-affinity Bcl-2 family inhibitor, in combination with gemcitabine in patients with solid tumors. Invest New Drugs. 2014 Oct;32(5):937-45. doi: 10.1007/s10637-014-0110-9. Epub 2014 Jun 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Navitoclax	Small molecule	150 mg	Oral
Subject	Navitoclax	Small molecule	325 mg	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Safety Study of ABT-263 in Combination With Gemzar (Gemcitabine) in Subjects With Solid Tumors

Summary

Timeline

Publications

Drugs

Indications