Back to resultsPhase II Trial of RAD001 in Refractory Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RAD001
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Metastatic, Refractory
Eligibility Criteria
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
Sites / Locations
- Swedish Cancer Institute
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00337545
First Posted
June 15, 2006
Last Updated
October 5, 2007
Sponsor
Swedish Medical Center
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00337545
Brief Title
Phase II Trial of RAD001 in Refractory Colorectal Cancer
Official Title
Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Swedish Medical Center
Collaborators
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Metastatic, Refractory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
RAD001
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Gold, M.D.
Organizational Affiliation
Swedish Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase II Trial of RAD001 in Refractory Colorectal Cancer
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