NCT01519414

Tivantinib in Treating Patients With Metastatic Prostate Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of ARQ 197 (Tivantinib) in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies how well tivantinib works compared to placebo in treating patients with metastatic prostate cancer. 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 progression-free survival (PFS) in men with minimally symptomatic or asymptomatic metastatic, castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197 (tivantinib). SECONDARY OBJECTIVES: I. To determine the prostate-specific antigen (PSA) response rate at 12 weeks in men with metastatic, castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197. II. To determine the radiographic response rate at 12 weeks based on Response Evaluation Criteria in Solid Tumors (RECIST) criteria on computed tomography (CT) scans and stability of bone lesions on bone scan in castrate-resistant, chemotherapy-naïve prostate cancer treated with ARQ 197. III. To determine the proportion of patients who are progression-free at 12 weeks. IV. To assess safety and tolerability in patients treated with ARQ 197 using the National Institute of Cancer (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grading of toxicities. TERTIARY OBJECTIVES: I. Evaluate markers of bone turnover. (Exploratory) OUTLINE: Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive tivantinib orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive placebo PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression may crossover to Arm I. After completion of study treatment, patients are followed up every 3 months for 6 months.

Conditions

• Hormone-Resistant Prostate Cancer
• Prostate Adenocarcinoma
• Recurrent Prostate Carcinoma
• Stage IV Prostate Cancer

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Optional correlative studies
OTHER	Placebo	Given PO
DRUG	Tivantinib	Given PO

Timeline

• Start date: 2012-01-11
• Primary completion: 2015-08-18
• Completion: 2015-08-18
• First posted: 2012-01-27
• Last updated: 2018-09-12
• Results posted: 2018-09-12

Locations

20 sites across 1 country: United States