NCT00612209

A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors

A Phase 1 Dose Escalation Study of ARQ 197 Given Twice Daily Continuously in Adult Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open label, single arm, dose escalation study of ARQ 197 in patients with advanced solid tumors.

Detailed description

Patients will take ARQ 197 orally twice daily continuously at dose levels specified for their respective dose cohorts. The ARQ 197 starting dose will be a total daily dose of 200 mg (100 mg bid). ARQ 197 treatment will be continued until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment is permitted. A treatment cycle is designed as four weeks (28 days) and will be repeated without therapy interruption.

Conditions

• Cancer, Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	ARQ 197	Treatment with ARQ 197

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-01-01
• Completion: 2010-02-01
• First posted: 2008-02-11
• Last updated: 2012-07-23

Locations

1 site across 1 country: United Kingdom