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Tivantinib in Treating Patients With Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01519414
Recruitment Status : Completed
First Posted : January 27, 2012
Results First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Hormone-Resistant Prostate Cancer
Prostate Adenocarcinoma
Recurrent Prostate Carcinoma
Stage IV Prostate Cancer
Interventions: Other: Laboratory Biomarker Analysis
Other: Placebo
Drug: Tivantinib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Tivantinib) Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II (Placebo) Patients receive matched placebo (3 tablets) 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.
Crossover From Placebo to Tivantinib Patients who were originally assigned to placebo and experience disease progression will be allowed to crossover and take ARQ 197. The treatment plan, duration of therapy, criteria for progression and follow-up will be the same as described above for men originally assigned to ARQ 197.

Participant Flow for 2 periods

Period 1:   Pre Cross-over
    Arm I (Tivantinib)   Arm II (Placebo)   Crossover From Placebo to Tivantinib
STARTED   52   26   0 
COMPLETED   52   26   0 
NOT COMPLETED   0   0   0 

Period 2:   Post Cross-over
    Arm I (Tivantinib)   Arm II (Placebo)   Crossover From Placebo to Tivantinib
STARTED   52   14   12 
COMPLETED   52   14   12 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Tivantinib) Patients receive tivantinib 360 mg (3 * 120 mg tablets) po BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II (Placebo) Patients receive matched placebo (3 tablets) 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.
Total Total of all reporting groups

Baseline Measures
   Arm I (Tivantinib)   Arm II (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   26   78 
Age 
[Units: Years]
Median (Full Range)
 67 
 (43 to 84) 
 66.5 
 (48 to 85) 
 67 
 (43 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      52 100.0%      26 100.0%      78 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   1.9%      0   0.0%      1   1.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   3.8%      6  23.1%      8  10.3% 
White      49  94.2%      20  76.9%      69  88.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Patients]
     
United States   52   26   78 


  Outcome Measures

1.  Primary:   Progression-free Survival (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 ]

2.  Secondary:   Changes in PSA Levels   [ Time Frame: Baseline to 12 weeks ]

3.  Secondary:   Proportion of Patients Who Respond   [ Time Frame: At 12 weeks ]

4.  Secondary:   PSA Response Rate   [ Time Frame: up to 12 weeks ]

5.  Secondary:   Incidence of Adverse Events Graded as 3, 4, or 5 Per NCI CTCAE Version 4.0   [ Time Frame: Up to 1 year ]

6.  Other Pre-specified:   Radiographic Response Rate Based on RECIST Criteria   [ Time Frame: Up to 12 weeks ]

7.  Other Pre-specified:   Change in Bone Specific Alkaline Phosphatase (BSAP) in Serum   [ Time Frame: Baseline to up to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Other Pre-specified:   Change in Markers of Bone Turnover in Urine   [ Time Frame: Baseline to up to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul Monk, MD
Organization: The Ohio State University Comprehensive Cancer Center
phone: (614) 293-6196
e-mail: Paul.Monk@osumc.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01519414     History of Changes
Other Study ID Numbers: NCI-2012-00237
NCI-2012-00237 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000721410
OSU11132
OSU-11132
OSU 11132 ( Other Identifier: Ohio State University Comprehensive Cancer Center )
8986 ( Other Identifier: CTEP )
N01CM00070 ( U.S. NIH Grant/Contract )
N01CM00071 ( U.S. NIH Grant/Contract )
N01CM00100 ( U.S. NIH Grant/Contract )
N01CM62207 ( U.S. NIH Grant/Contract )
P30CA016058 ( U.S. NIH Grant/Contract )
U01CA062491 ( U.S. NIH Grant/Contract )
First Submitted: January 25, 2012
First Posted: January 27, 2012
Results First Submitted: October 11, 2017
Results First Posted: September 12, 2018
Last Update Posted: September 12, 2018