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BEZ235 in Patients With Advanced Renal Cell Carcinoma (RCC)

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ClinicalTrials.gov Identifier: NCT01453595
Recruitment Status : 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.)
First Posted : October 18, 2011
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cancer
Intervention Drug: BEZ235
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort 1: BEZ235 400mg Cohort -1: BEZ235 200mg Cohort -1a: BEZ235 300mg
Hide Arm/Group Description Cohort 1: BEZ235 400mg by mouth twice daily Cohort -1: BEZ235 200mg by mouth twice daily Cohort -1a: BEZ235 300mg by mouth twice daily
Period Title: Overall Study
Started 2 6 2
Completed 0 5 0
Not Completed 2 1 2
Reason Not Completed
Dose Limiting Toxicity (DLT)             2             1             2
Arm/Group Title Cohort 1: BEZ235 400mg Cohort -1: BEZ235 200mg Cohort -1a: BEZ235 300mg Total
Hide Arm/Group Description Cohort 1: BEZ235 400mg by mouth twice daily Cohort -1: BEZ235 200mg by mouth twice daily Cohort -1a: BEZ235 300mg by mouth twice daily Total of all reporting groups
Overall Number of Baseline Participants 2 6 2 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 6 participants 2 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
5
  83.3%
1
  50.0%
6
  60.0%
>=65 years
2
 100.0%
1
  16.7%
1
  50.0%
4
  40.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 6 participants 2 participants 10 participants
Female
0
   0.0%
2
  33.3%
1
  50.0%
3
  30.0%
Male
2
 100.0%
4
  66.7%
1
  50.0%
7
  70.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 2 participants 6 participants 2 participants 10 participants
2 6 2 10
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description In patients with advanced clear cell RCC, progressing after prior first-line or second-line mTOR therapy. The determination of antitumor efficacy will be based on objective tumor assessments made according to the RECIST1.1.
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ORR was only assessed for participants who completed the study, which were only 5 patients on Cohort -1
Arm/Group Title Cohort -1: BEZ235 200mg
Hide Arm/Group Description:
Cohort -1: BEZ235 200mg by mouth twice daily
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Progression of Disease 3
Stable Disease 2
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort 1: BEZ235 400mg Cohort -1: BEZ235 200mg Cohort -1a: BEZ235 300mg
Hide Arm/Group Description Cohort 1: BEZ235 400mg by mouth twice daily Cohort -1: BEZ235 200mg by mouth twice daily Cohort -1a: BEZ235 300mg by mouth twice daily
All-Cause Mortality
Cohort 1: BEZ235 400mg Cohort -1: BEZ235 200mg Cohort -1a: BEZ235 300mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Cohort 1: BEZ235 400mg Cohort -1: BEZ235 200mg Cohort -1a: BEZ235 300mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/6 (16.67%)      1/2 (50.00%)    
Gastrointestinal disorders       
Abdominal pain  1  0/2 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
General disorders       
Fatigue  1  0/2 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Non-cardiac chest pain  1  0/2 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cohort 1: BEZ235 400mg Cohort -1: BEZ235 200mg Cohort -1a: BEZ235 300mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      3/6 (50.00%)      2/2 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  0/2 (0.00%)  0 1/6 (16.67%)  3 0/2 (0.00%)  0
Gastrointestinal disorders       
Mucositis oral  1  1/2 (50.00%)  1 1/6 (16.67%)  1 0/2 (0.00%)  0
Nausea  1  1/2 (50.00%)  1 0/6 (0.00%)  0 1/2 (50.00%)  1
Vomiting  1  1/2 (50.00%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0
General disorders       
Fatigue  1  2/2 (100.00%)  2 1/6 (16.67%)  1 1/2 (50.00%)  2
Non-cardiac chest pain  1  0/2 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1
Investigations       
Blood bilirubin increased  1  0/2 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
INR increased  1  0/2 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Metabolism and nutrition disorders       
Hyperglycemia  1  0/2 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Hypercalcemia  1  0/2 (0.00%)  0 1/6 (16.67%)  1 0/2 (0.00%)  0
Anorexia  1  0/2 (0.00%)  0 0/6 (0.00%)  0 1/2 (50.00%)  1
Skin and subcutaneous tissue disorders       
Rash maculo-papular  1  1/2 (50.00%)  1 0/6 (0.00%)  0 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Given the number of toxicities seen and the difficulty with patient retention in the dose escalation portion, the sponsor decided to close the trial.
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
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01453595     History of Changes
Other Study ID Numbers: 11-080
First Submitted: October 13, 2011
First Posted: October 18, 2011
Results First Submitted: December 14, 2015
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016