CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
Tivantinib +1 moredrug
Likely dose
Tivantinib 360 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01178411
NCT01178411Phase 2Completed
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An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)·interventional·Posted Aug 10, 2010·Updated Mar 10, 2021

In Brief

A Phase 2 clinical trial evaluating Tivantinib and Anti-Cancer Combination Therapy for Advanced Solid Tumors. Completed, enrolled 60 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2010
Enrollment StartAug 31, 2010
Primary CompletionJan 14, 2019
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 15.9 years ago

Interventions

Tivantinibdrug

Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.

Anti-Cancer Combination Therapydrug

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.