NCT01178411

An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

This is an extension study that will allow participants to continue to receive study therapy when the original studies into which they were enrolled have reached their designated end-dates. This extension study is designed to further evaluate the safety and tolerability of tivantinib (ARQ 197) monotherapy or in combination with other drug(s) when given to participants who tolerated previous treatment well and may benefit from the continuing treatment.

Detailed description

This open label extension protocol enrolls participants who were treated in previous phase 1 (NCT01149720, NCT01517399, NCT01699061, NCT00612703, NCT00827177, and NCT00874042) and phase 2 (NCT00777309, NCT00557609, NCT00988741, NCT01395758 , and NCT01055067) tivantinib studies that have reached their designated end-dates. Participants enrolled in this extension protocol will provide further safety and tolerability information about tivantinib monotherapy or in combination with other drug(s) at the same dose(s), and same schedule(s) in which they were originally enrolled.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Tivantinib	Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.
DRUG	Anti-Cancer Combination Therapy	Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the same dose and schedule in which they were administered in the original (previous) study.

Timeline

• Start date: 2010-08-31
• Primary completion: 2019-01-14
• Completion: 2019-01-14
• First posted: 2010-08-10
• Last updated: 2021-03-10
• Results posted: 2021-02-17