Linsitinib in Treating Patients With Asymptomatic or Mildly Symptomatic Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01533246
First received: February 10, 2012
Last updated: March 2, 2015
Last verified: December 2013
Results First Received: March 2, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Prostate
Hormone-resistant Prostate Cancer
Recurrent Prostate Cancer
Stage IV Prostate Cancer
Interventions: Drug: linsitinib
Other: laboratory biomarker analysis

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
18 patients were entered into the trial between February 2012 and April 2012 form local medical hospitals. One patient was considered ineligible and has been excluded from all analyses.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Treatment (Linsitinib)

Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.

linsitinib: Given PO

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Treatment (Linsitinib)  
STARTED     17  
COMPLETED     15  
NOT COMPLETED     2  
Adverse Event                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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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.
Patients that received treatment.

Reporting Groups
  Description
Treatment (Linsitinib)

Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.

linsitinib: Given PO

laboratory biomarker analysis: Correlative studies


Baseline Measures
    Treatment (Linsitinib)  
Number of Participants  
[units: participants]
  17  
Age, Customized  
[units: participants]
 
50-59 years     2  
60-69 years     7  
70-79 years     8  
Gender  
[units: participants]
 
Female     0  
Male     17  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     17  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     3  
White     14  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     17  



  Outcome Measures
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1.  Primary:   PSA Response Analyzed Using the PCWG2 Definition   [ Time Frame: 12 weeks ]

2.  Secondary:   Incidence of Toxicities Based on CTCAE Version 4.0 Criteria   [ Time Frame: Up to 2 years ]

3.  Secondary:   Number of Patients With Bidimensional Measurable Disease RECIST-based Response   [ Time Frame: Up to 2 years ]

4.  Secondary:   Time to PSA Progression (TTPP) Analyzed Using the PCWG2 Definition   [ Time Frame: assessed up to 12 weeks ]

5.  Secondary:   Overall Survival Based on the RECIST v1.1   [ Time Frame: Up to 2 years ]

6.  Secondary:   Progression Free Survival   [ Time Frame: assessed up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Dr. Jorge Garcia
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
phone: 216-444-7774
e-mail: garciaj4@ccf.org


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01533246     History of Changes
Other Study ID Numbers: NCI-2012-00247, NCI-2012-00247, CDR0000724845, CASE 6810, 8872, U01CA062502
Study First Received: February 10, 2012
Results First Received: March 2, 2015
Last Updated: March 2, 2015
Health Authority: United States: Food and Drug Administration