Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Cabozantinib (XL184) in Men With Castrate-Resistant Prostate Cancer

This study has been completed.
Information provided by (Responsible Party):
Matthew R. Smith, MD, PhD, Massachusetts General Hospital Identifier:
First received: April 11, 2011
Last updated: October 16, 2015
Last verified: October 2015
Results First Received: September 15, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Prostate Adenocarcinoma
Intervention: Drug: cabozantinib

  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
No text entered.

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
Dose Level 0 Cabozantinib 40 mg daily
Dose Level -1 Cabozantinib 20 mg daily
Expansion Cohort Cabozantinib 40 mg daily

Participant Flow:   Overall Study
    Dose Level 0   Dose Level -1   Expansion Cohort
STARTED   11   10   13 
COMPLETED   11   10   13 
NOT COMPLETED   0   0   0 

  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.
See Lee et al CCR 2013

Reporting Groups

Final results have been published Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.

A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.

Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR.

Author information Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA.

Baseline Measures
Overall Participants 
[units: participants]
[units: years]
Median (Full Range)
 (48 to 83) 
[units: participants]
<=18 years   0 
Between 18 and 65 years   24 
>=65 years   10 
[units: participants]
Female   0 
Male   34 
Region of Enrollment 
[units: participants]
United States   34 

  Outcome Measures

1.  Primary:   Partial Response in Bone Scan From Baseline to Week 6   [ Time Frame: Baseline and Week 6 ]

  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 NOT 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.

Results Point of Contact:  
Name/Title: Matthew R Smith, MDPhD
Organization: Massachusetts General Hospital
phone: 617-763-3748

Publications of Results:

Responsible Party: Matthew R. Smith, MD, PhD, Massachusetts General Hospital Identifier: NCT01347788     History of Changes
Other Study ID Numbers: 11-005
Study First Received: April 11, 2011
Results First Received: September 15, 2014
Last Updated: October 16, 2015
Health Authority: United States: Food and Drug Administration