A Study of MGCD265 Given With Erlotinib or Docetaxel in Subjects With Advanced Malignancies or Non-Small Cell Lung Cancer

Phase 1 Terminated 126 enrolled Mirati Therapeutics Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The main purpose of this study is to assess the safety profile of MGCD265 when administered in combination with the marketed anticancer drugs erlotinib and docetaxel.

Timeline

Start: 2009-08
Primary completion: 2013-07
Completion: 2014-08

Outcome

Outcome not reported

Stopped (Enrollment): “The study was terminated due to a need for a reformulation of the study drug. Phase 1 completed, no patients enrolled in Phase 2.”

Publications

Patnaik A, Gadgeel S, Papadopoulos KP, Rasco DW, Haas NB, Der-Torossian H, Faltaos D, Potvin D, Tassell V, Tawashi M, Chao R, O'Dwyer PJ. Phase I Study of Glesatinib (MGCD265) in Combination with Erlotinib or Docetaxel in Patients with Advanced Solid Tumors. Target Oncol. 2022 Mar;17(2):125-138. doi: 10.1007/s11523-022-00875-0. Epub 2022 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	50 mg/m2	—
Subject	Docetaxel	Small molecule	75 mg/m2	—
Subject	Erlotinib	Small molecule	100 mg	—
Subject	Erlotinib	Small molecule	150 mg	—
Subject	Glesatinib	Small molecule	96 mg/m2	Oral
Subject	Glesatinib	Small molecule	700 mg	Oral