Overview

Phase I/II Trial of Tivantinib With FOLFOX for the Treatment of Advanced Solid Tumors and Previously Untreated Metastatic Adenocarcinoma of the Distal Esophagus, Gastroesophageal Junction or Stomach

Status:
Completed

Trial end date:
2015-08-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 1/Phase 2

Details

Lead Sponsor:

SCRI Development Innovations, LLC

Collaborators:

Daiichi Sankyo Inc.
Daiichi Sankyo, Inc.

Treatments:

Fluorouracil
Leucovorin
Levoleucovorin
Oxaliplatin