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Brief Title: Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma
Official Title: A Phase 2 Study of ARQ 197 in Patients With Previously-Treated Malignant Mesothelioma
Study ID: NCT01861301
Brief Summary: This phase II trial studies how well tivantinib works in treating patients with previously treated malignant mesothelioma. Tivantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the objective response rate of patients with malignant mesothelioma who are treated with ARQ 197 (tivantinib). SECONDARY OBJECTIVES: I. To determine the progression-free survival of patients with malignant mesothelioma who are treated with ARQ 197. II. To determine the toxicity experienced by patients with malignant mesothelioma who are treated with ARQ 197. III. To determine median and overall survival of patients with malignant mesothelioma who are treated with ARQ 197. TERTIARY OBJECTIVES: I. To determine the frequency of mesenchymal-epithelial transition (MET) gene amplification in malignant mesothelioma patient tumor samples, and to correlate the results with MET immunohistochemistry (IHC). II. To determine whether MET gene amplification results in increased sensitivity to ARQ 197 as observed by improved clinical outcomes (response rate \[RR\] and progression free survival \[PFS\]) compared to those without MET gene over-expression/amplification. III. To determine whether high baseline serum hepatocyte growth factor (HGF), as well as changes in serum HGF during treatment at pre-defined early time points, correlate with treatment efficacy and clinical outcome, as measured by response rate and progression-free survival. IV. To identify mutations by sequencing of specific areas of the MET gene in tumor samples (semaphorin \[SEMA\], jumonji \[JM\] and tyrosine kinase domains). V. To perform immunohistochemistry (IHC) of mesothelioma tumors for HGF, MET and phosphorylated (p)-MET (pY1003 and pY1230/34/35). VI. To assess serum HGF and serum soluble MET levels by enzyme linked immunosorbent assay (ELISA) (R\&D systems) pre-treatment, after 2 cycles and at disease progression. OUTLINE: Patients receive tivantinib orally (PO) twice daily (BID). Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 1 year.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope Comprehensive Cancer Center, Duarte, California, United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
City of Hope South Pasadena, South Pasadena, California, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Southern Illinois University School of Medicine, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview, Fort Wayne, Indiana, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Penn State Milton S Hershey Medical Center, Hershey, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Name: Hedy Kindler
Affiliation: University of Chicago Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR