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RAD001 and Intravesical Gemcitabine in BCG-Refractory Primary or Secondary Carcinoma In Situ of the Bladder

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ClinicalTrials.gov Identifier: NCT01259063
Recruitment Status : Completed
First Posted : December 13, 2010
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
Novartis Pharmaceuticals
New York University
University of Hawaii
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: Bladder Cancer
Intervention: Drug: Everolimus and Intravesical Gemcitabine

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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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
Everolimus and Intravesical Gemcitabine Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response.

Participant Flow:   Overall Study
    Everolimus and Intravesical Gemcitabine
STARTED   33 
COMPLETED   33 
NOT COMPLETED   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.
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Reporting Groups
  Description
Pts Who Failed or Relapsed After Intravesical BCG Phase I: Everolimus will be administered as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be administered at the dose determined in Phase .Everolimus will be continued for 12 months in the patients who achieve a CR or a Partial Response. Patients demonstrating a CR (by cystoscopy and cytology) or a Partial Response at their Cycle 12 cystoscopy will be observed with serial cystoscopies every 3 months.

Baseline Measures
   Pts Who Failed or Relapsed After Intravesical BCG 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age 
[Units: Years]
Median (Full Range)
 66 
 (49 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  12.1% 
Male      29  87.9% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   3.0% 
Not Hispanic or Latino      32  97.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2   6.1% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   6.1% 
White      29  87.9% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
 
United States   33 


  Outcome Measures

1.  Primary:   Phase I - Dose-limiting Toxicity (DLT)   [ Time Frame: 8 weeks ]

2.  Primary:   Phase II - Patients Who Are Free of Disease at 1 Year   [ Time Frame: 1 year ]

3.  Primary:   Phase I - Maximum Tolerated Dose (MTD)   [ Time Frame: 8 weeks ]

4.  Secondary:   Complete Response (CR) Rate   [ Time Frame: 1 year ]

5.  Secondary:   Survival of Patients Treated   [ Time Frame: 1 year ]

6.  Secondary:   Activated mTOR (Mammalian Target of Rapamycin) Pathway Markers as Well as Phosphatase and Tensin Homolog (PTEN) Status and Serine/Threonine Kinase (AKT) Activation Evaluation   [ Time Frame: 1 year ]


  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
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  More Information

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


Results Point of Contact:  
Name/Title: Dr. Guido Dalbagni
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-422-4394
e-mail: dalbagng@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01259063     History of Changes
Other Study ID Numbers: 10-165
First Submitted: December 9, 2010
First Posted: December 13, 2010
Results First Submitted: December 6, 2017
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018