NCT01611857 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 31, 2012

Primary Completion Date

July 31, 2015

Study Completion Date

August 31, 2015

Conditions

Malignant Solid TumourGastroesophageal Cancer

Interventions

DRUG

Tivantinib

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.

DRUG

FOLFOX

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.

Trial Locations (9)

29210

South Carolina Oncology Associates, Columbia

33705

Florida Cancer Specialists-North, St. Petersburg

33916

Florida Cancer Specialists-South, Fort Myers

34232

Florida Cancer Specialists-Sarasota, Sarasota

37023

Tennessee Oncology, PLLC, Nashville

37404

Tennessee Oncology - Chattanooga, Chattanooga

73104

Oklahoma University, Oklahoma City

76104

Center for Cancer and Blood Disorders, Fort Worth

06520

Yale University School of Medicine, New Haven