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
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|ClinicalTrials.gov Identifier: NCT01611857|
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : November 23, 2016
Last Update Posted : November 23, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Solid Tumour Gastroesophageal Cancer||Drug: Tivantinib Drug: FOLFOX||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||August 2015|
Experimental: Maximum Tolerated Dose
Phase I trial of Tivantinib plus FOLFOX for the treatment of patients with advanced solid tumors followed by a Phase II portion for patients with first-line metastatic GE cancer.
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.
Other Name: ARQ 197
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.
- The Incidence of Dose Limiting Toxicities (DLT) in Phase I Dose Escalation [ Time Frame: 14 Days (1 cycle) ]Using a standard 3+3 design participants were enrolled in dose-escalating cohorts to determine the maximum tolerated dose (MTD) of tivantinib when given with FOLFOX (5-FU 400 mg/m^2, continuous IV 5-FU 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2). MTD is defined as the highest dose level at which no more than 1 of 6 patients experiences a DLT, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
- Progression Free Survival in Phase II Dose Expansion [ Time Frame: every 8 weeks until treatment discontinuation, projected 18 months and then every 3 months thereafter up to 5 years from start of treatment. ]Defined as the time from first treatment until objective tumor progression or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Overall Survival in Phase II Dose Expansion [ Time Frame: every 8 weeks until treatment discontinuation, an expected average of 18 months, then every 12 weeks thereafter up to 5 years from start of treatment. ]Defined as the time from first treatment until death from any cause.
- Time to Progression in Phase II Dose Expansion [ Time Frame: every 8 weeks until progressive disease, expected 18 months. ]Defined as the time from first treatment until objective tumor progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01611857
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Florida|
|Florida Cancer Specialists-South|
|Fort Myers, Florida, United States, 33916|
|Florida Cancer Specialists-Sarasota|
|Sarasota, Florida, United States, 34232|
|Florida Cancer Specialists-North|
|St. Petersburg, Florida, United States, 33705|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, South Carolina|
|South Carolina Oncology Associates|
|Columbia, South Carolina, United States, 29210|
|United States, Tennessee|
|Tennessee Oncology - Chattanooga|
|Chattanooga, Tennessee, United States, 37404|
|Tennessee Oncology, PLLC|
|Nashville, Tennessee, United States, 37023|
|United States, Texas|
|Center for Cancer and Blood Disorders|
|Fort Worth, Texas, United States, 76104|
|Study Chair:||Johanna C Bendell, M.D.||SCRI Development Innovations, LLC|