ClinicalTrials.gov
ClinicalTrials.gov Menu

RAD001 in Previously Treated Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00409292
Recruitment Status : Completed
First Posted : December 8, 2006
Results First Posted : August 11, 2014
Last Update Posted : August 11, 2014
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Novartis
Information provided by (Responsible Party):
Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Intervention: Drug: RAD001

  Participant Flow

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
RAD001

RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.

Four weeks of study drug was considered to be one cycle of treatment.


Participant Flow:   Overall Study
    RAD001
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.
Our study design used a one-stage design with a target accrual of 35 eligible patients, with the assumption that an improvement in PFS at 2 months from 50% to 71% would warrant further study in this patient population.

Reporting Groups
  Description
RAD001 RAD001: Taken orally daily for as long as the participant continues to receive a benefit.

Baseline Measures
   RAD001 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age, Customized 
[Units: Years]
Median (Full Range)
 61 
 (39 to 78) 
Gender 
[Units: Participants]
 
Female   15 
Male   18 
Region of Enrollment 
[Units: Participants]
 
United States   33 


  Outcome Measures

1.  Primary:   To Assess Progression-free Survival of RAD001 at Two Months in Patients With Metastatic Pancreatic Cancer Whose Disease Has Progressed on Gemcitabine Chemotherapy.   [ Time Frame: two months ]

2.  Secondary:   To Assess the Safety of RAD001 in Patients With Metastatic Pancreatic Cancer   [ Time Frame: Patients were followed for the duration of their time on treatment and 30 days after their last dose of RAD001. ]

3.  Secondary:   to Assess Response Rate Associated With RAD001 in This Patient Population.   [ Time Frame: 2 years ]

4.  Secondary:   to Assess Overall Survival Associated With RAD001 in This Patient Population.   [ Time Frame: 2 years ]


  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
No text entered.


  More Information

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: Brian Wolpin, MD
Organization: Dana-Farber Cancer Institute
phone: 617-632-3000
e-mail: brian_wolpin@dfci.harvard.edu


Publications of Results:

Responsible Party: Brian Wolpin, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00409292     History of Changes
Other Study ID Numbers: 06-197
First Submitted: December 6, 2006
First Posted: December 8, 2006
Results First Submitted: April 30, 2014
Results First Posted: August 11, 2014
Last Update Posted: August 11, 2014