CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 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/NCT01611857
NCT01611857Phase 2Completed
CompareCT.gov

A Phase I/II Trial of the c-Met Inhibitor, Tivantinib, in Combination With FOLFOX for the Treatment of Patients With Advanced Solid Tumors (Phase I) and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal (GE) Junction, or Stomach (Phase II)

SCRI Development Innovations, LLC·interventional·Posted Jun 5, 2012·Updated Nov 23, 2016

In Brief

A Phase 2 clinical trial evaluating Tivantinib and FOLFOX for Malignant Solid Tumour and Gastroesophageal Cancer. Completed, enrolled 49 participants across 9 sites.

Detailed Summary

This study is a Phase I/II trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors. In Phase I the Maximum Tolerated Dose (MTD) will be determined; in Phase II patients with first-line metastatic GE cancer will be treated at the MTD. It is hypothesized that the response rate (RR) will be improved from 45% to at least 65% under this regimen.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Solid Tumour, Gastroesophageal Cancer
CountriesUnited States
CollaboratorsDaiichi Sankyo

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 5, 2012
Enrollment StartJul 1, 2012
Primary CompletionJul 1, 2015
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 14.1 years ago

Interventions

Tivantinibdrug

Patients with advanced solid tumors will be treated with oral Tivantinib (120, 240, or 360 mg BID) daily for 14 days in cycles of 14 days.

FOLFOXdrug

The FOLFOX treatment regimen is started on Day 1 of each cycle and consists of 5-Fluorouracil (5-FU) 400 mg/m\^2, 5-FU continuous IV 2400 mg/m\^2 over 46 hours, leucovorin 400 mg/m\^2 IV, and oxaliplatin 85 mg/m\^2.