Dose Escalation Study of ARQ 197 in Combination With Gemcitabine in Adult Patients With Advanced Solid Tumors

Phase 1 Completed 74 enrolled ArQule, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is an open-label, dose-escalation/de-escalation study of ARQ 197 administered orally in combination with gemcitabine. The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of ARQ 197 when administered in combination with gemcitabine to patients with advanced solid tumors.

Timeline

Start: 2009-03
Primary completion: 2011-02
Completion: 2011-04

Publications

Pant S, Saleh M, Bendell J, Infante JR, Jones S, Kurkjian CD, Moore KM, Kazakin J, Abbadessa G, Wang Y, Chen Y, Schwartz B, Camacho LH. A phase I dose escalation study of oral c-MET inhibitor tivantinib (ARQ 197) in combination with gemcitabine in patients with solid tumors. Ann Oncol. 2014 Jul;25(7):1416-1421. doi: 10.1093/annonc/mdu157. Epub 2014 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tivantinib	Small molecule	120 mg	Oral
Subject	Tivantinib	Small molecule	240 mg	Oral
Subject	Tivantinib	Small molecule	360 mg	Oral
Background	Gemcitabine	Small molecule	1000 mg/m2	Intravenous

Dose Escalation Study of ARQ 197 in Combination With Gemcitabine in Adult Patients With Advanced Solid Tumors

Summary

Timeline

Publications

Drugs

Indications