Tivantinib in Treating Patients With Metastatic Prostate Cancer
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.
Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Other: laboratory biomarker analysis
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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.|
- PFS based on the RECIST criteria [ Time Frame: Time from study entry to the date of documented progression and/or death, assessed up to 6 months ] [ Designated as safety issue: No ]The progression-free survival distributions between the two arms will be compared using log-rank tests. Progression-free survival curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model.
- PSA response rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.
- Changes in PSA levels [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]Evaluated and patterns graphically explored through waterfall plots.
- Radiographic response rate based on RECIST criteria [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.
- Proportion of patients who respond [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]An assumed binomial distribution used. Summarized with their corresponding 95% binomial confidence intervals and compared in an exploratory manner between the two treatment arms. Dichotomized outcomes of response will be descriptively summarized and graphically evaluated using bar graphs.
- Incidence of toxicities graded as 3, 4, or 5 per NCI CTCAE v 4.0 [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and graphically assessed differences in maximum grades observed for toxicities between the arms.
|Study Start Date:||January 2012|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: Arm I (tivantinib)
Patients receive tivantinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Given POOther: laboratory biomarker analysis
Optional correlative studies
Placebo Comparator: Arm II (placebo)
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.
Given POOther: laboratory biomarker analysis
Optional correlative studies
I. To determine progression-free survival (PFS) of men with minimally symptomatic or asymptomatic metastatic, castrate-resistant, chemotherapy-naïve prostate cancer treated with tivantinib (ARQ 197).
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.
I. Evaluate markers of bone turnover. (Exploratory)
OUTLINE: This is a multicenter study. Patients are stratified according to prior abiraterone or sipuleucel-T therapy (yes vs no). 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.
Patients may undergo serum and urine sample collection at baseline and periodically during treatment for biomarker studies.
After completion of study treatment, patients are followed up every 3 months for 6 months.
|United States, District of Columbia|
|Lombardi Comprehensive Cancer Center at Georgetown University||Recruiting|
|Washington, District of Columbia, United States, 20057|
|Contact: Nancy A. Dawson 202-444-9094 Nad103@gunet.georgetown.edu|
|Principal Investigator: Nancy A. Dawson|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Shilpa Gupta 813-745-8418 Shilpa.email@example.com|
|Principal Investigator: Shilpa Gupta|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Timothy M. Kuzel 312-695-4544 firstname.lastname@example.org|
|Principal Investigator: Timothy M. Kuzel|
|University of Chicago Comprehensive Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60637-1470|
|Contact: Walter M. Stadler 773-702-4150 email@example.com|
|Principal Investigator: Walter M. Stadler|
|Decatur Memorial Hospital||Recruiting|
|Decatur, Illinois, United States, 62526|
|Contact: James L. Wade 217-876-6600 Jlwade3@sbcglobal.net|
|Principal Investigator: James L. Wade|
|Evanston CCOP-NorthShore University HealthSystem||Recruiting|
|Evanston, Illinois, United States, 60201|
|Contact: Daniel H. Shevrin 847-570-2515 firstname.lastname@example.org|
|Principal Investigator: Daniel H. Shevrin|
|Ingalls Memorial Hospital||Recruiting|
|Harvey, Illinois, United States, 60426|
|Contact: Mark F. Kozloff 708-339-4800 email@example.com|
|Principal Investigator: Mark F. Kozloff|
|Peoria, Illinois, United States, 61615|
|Contact: Sachdev P. Thomas 309-243-3605 firstname.lastname@example.org|
|Principal Investigator: Sachdev P. Thomas|
|Southern Illinois University||Recruiting|
|Springfield, Illinois, United States, 62702|
|Contact: Krishna A. Rao 217-545-5817 email@example.com|
|Principal Investigator: Krishna A. Rao|
|United States, Indiana|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Recruiting|
|Fort Wayne, Indiana, United States, 46845|
|Contact: Sreenivasa R. Nattam 206-484-8830 firstname.lastname@example.org|
|Principal Investigator: Sreenivasa R. Nattam|
|Indiana University Medical Center||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Noah M. Hahn 317-278-6871 email@example.com|
|Principal Investigator: Noah M. Hahn|
|United States, Maryland|
|University of Maryland Greenebaum Cancer Center||Recruiting|
|Baltimore, Maryland, United States, 21201-1595|
|Contact: Martin J. Edelman 410-328-2700 firstname.lastname@example.org|
|Principal Investigator: Martin J. Edelman|
|University of Maryland Saint Joseph Medical Center||Recruiting|
|Towson, Maryland, United States, 21204|
|Contact: Richard Schrader 410-427-5585 email@example.com|
|Principal Investigator: Richard Schrader|
|United States, Missouri|
|Saint John's Mercy Medical Center||Recruiting|
|Saint Louis, Missouri, United States, 63141|
|Contact: Bethany G. Sleckman 314-251-7057 firstname.lastname@example.org|
|Principal Investigator: Bethany G. Sleckman|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roberto Pili 716-845-3851 Roberto.Pili@RoswellPark.org|
|Principal Investigator: Roberto Pili|
|United States, Ohio|
|Case Western Reserve University||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Matthew M. Cooney 216-844-3042 Matthew.email@example.com|
|Principal Investigator: Matthew M. Cooney|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Jorge A. Garcia 216-444-7774 Garciaj4@ccf.org|
|Principal Investigator: Jorge A. Garcia|
|Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: J. P. Monk 614-293-2886 Paul.Monk@osumc.edu|
|Principal Investigator: J. P. Monk|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics||Recruiting|
|Madison, Wisconsin, United States, 53792|
|Contact: Glenn Liu 608-263-7107 firstname.lastname@example.org|
|Principal Investigator: Glenn Liu|
|Principal Investigator:||J. Monk||Ohio State University|