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Phase II Trial of RAD001 in Refractory Colorectal 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: NCT00337545
Recruitment Status : Completed
First Posted : June 16, 2006
Last Update Posted : October 10, 2007
Sponsor:
Collaborator:
Novartis
Information provided by:
Swedish Medical Center

Tracking Information
First Submitted Date  ICMJE June 15, 2006
First Posted Date  ICMJE June 16, 2006
Last Update Posted Date October 10, 2007
Study Start Date  ICMJE May 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Trial of RAD001 in Refractory Colorectal Cancer
Official Title  ICMJE Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer
Brief Summary Single center open-label study of an oral agent (RAD001) in subjects with metastatic colorectal cancer refractory to at least 2 standard chemo/biologic regimens.
Detailed Description Study is completed and closed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: RAD001
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 16, 2007)		 22
Original Enrollment  ICMJE
 (submitted: June 15, 2006)		 40
Study Completion Date  ICMJE April 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic colorectal cancer refractory to at least 2 chemo/biologic regimens
  • Measurable disease
  • ECOG 0-2

Exclusion Criteria:

  • CNS disease
  • Chemotherapy or radiotherapy < 4 weeks prior
  • Active bleeding diathesis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00337545
Other Study ID Numbers  ICMJE CRAD0012467
Swedish Cancer Institute 05128
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Swedish Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Philip Gold, M.D. Swedish Cancer Institute
PRS Account Swedish Medical Center
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP