CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
Erlotinib Hydrochloride +2 moredrug
Likely dose
Erlotinib Hydrochloride 150 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/NCT01688973
NCT01688973Phase 2Completed
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Parallel (Randomized) Phase II Evaluation of ARQ 197 and ARQ 197 in Combination With Erlotinib in Papillary Renal Cell Carcinoma

National Cancer Institute (NCI)·interventional·Posted Sep 20, 2012·Updated Jan 3, 2019

In Brief

A Phase 2 clinical trial evaluating Erlotinib Hydrochloride, Laboratory Biomarker Analysis, and 1 other intervention for Recurrent Renal Cell Carcinoma and 4 related conditions. Completed, enrolled 55 participants across 214 sites.

Detailed Summary

This randomized phase II trial studies how well tivantinib with or without erlotinib hydrochloride works in treating patients with metastatic or locally advanced kidney cancer that cannot be removed by surgery. Tivantinib and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRecurrent Renal Cell Carcinoma, Stage III Renal Cell Cancer, Stage IV Renal Cell Cancer, Type 1 Papillary Renal Cell Carcinoma, Type 2 Papillary Renal Cell Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2012
Enrollment StartAug 20, 2012
Primary CompletionApr 30, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 13.8 years ago

Interventions

Erlotinib Hydrochloridedrug

150 mg (1 tablet) by mouth on days 1-28, once daily, until disease progression

Laboratory Biomarker Analysisother

Correlative studies

Tivantinibdrug

360 mg (3 tablets) by mouth, Twice daily (720 mg total daily dose) on days 1-28, until disease progression