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BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)

This study has been terminated.
(Given the number of toxicities seen and the difficulty with patient retention in the dose escalation portion, the sponsor decided to close the trial.)
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01453595
First received: October 13, 2011
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: December 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Renal Cancer
Intervention: Drug: BEZ235

  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
No text entered.

Reporting Groups
  Description
Cohort 1: BEZ235 400mg Cohort 1: BEZ235 400mg by mouth twice daily
Cohort -1: BEZ235 200mg Cohort -1: BEZ235 200mg by mouth twice daily
Cohort -1a: BEZ235 300mg Cohort -1a: BEZ235 300mg by mouth twice daily

Participant Flow:   Overall Study
    Cohort 1: BEZ235 400mg   Cohort -1: BEZ235 200mg   Cohort -1a: BEZ235 300mg
STARTED   2   6   2 
COMPLETED   0   5   0 
NOT COMPLETED   2   1   2 
Dose Limiting Toxicity (DLT)                2                1                2 



  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.
No text entered.

Reporting Groups
  Description
Cohort 1: BEZ235 400mg Cohort 1: BEZ235 400mg by mouth twice daily
Cohort -1: BEZ235 200mg Cohort -1: BEZ235 200mg by mouth twice daily
Cohort -1a: BEZ235 300mg Cohort -1a: BEZ235 300mg by mouth twice daily
Total Total of all reporting groups

Baseline Measures
   Cohort 1: BEZ235 400mg   Cohort -1: BEZ235 200mg   Cohort -1a: BEZ235 300mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   6   2   10 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   0   5   1   6 
>=65 years   2   1   1   4 
Gender 
[Units: Participants]
       
Female   0   2   1   3 
Male   2   4   1   7 
Region of Enrollment 
[Units: Participants]
       
United States   2   6   2   10 


  Outcome Measures

1.  Primary:   Objective Response Rate (ORR)   [ Time Frame: 1 year ]


  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
Given the number of toxicities seen and the difficulty with patient retention in the dose escalation portion, the sponsor decided to close the trial.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Martin Voss
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-422-4631
e-mail: vossm@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01453595     History of Changes
Other Study ID Numbers: 11-080
Study First Received: October 13, 2011
Results First Received: December 14, 2015
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration