Clinical Trials Directory

Trials / Terminated

TerminatedNCT01861301

Tivantinib in Treating Patients With Previously Treated Malignant Mesothelioma

A Phase 2 Study of ARQ 197 in Patients With Previously-Treated Malignant Mesothelioma

Status
Terminated
Phase
Phase 2
Study type
Interventional
Enrollment
18 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERLaboratory Biomarker AnalysisCorrelative studies
DRUGTivantinibGiven PO

Timeline

Start date
2013-01-01
Primary completion
2015-03-01
Completion
2015-03-01
First posted
2013-05-23
Last updated
2016-10-24
Results posted
2016-10-24

Locations

18 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01861301. Inclusion in this directory is not an endorsement.