⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Hedy Kindler

Affiliation: University of Chicago Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: