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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: RAD001 Phase 2

Detailed Description:
Study is completed and closed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer
Study Start Date : May 2006
Study Completion Date : April 2007
Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00337545


Locations
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United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Novartis
Investigators
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Principal Investigator: Philip Gold, M.D. Swedish Cancer Institute
More Information
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ClinicalTrials.gov Identifier: NCT00337545    
Other Study ID Numbers: CRAD0012467
Swedish Cancer Institute 05128
First Posted: June 16, 2006    Key Record Dates
Last Update Posted: October 10, 2007
Last Verified: October 2007
Keywords provided by Swedish Medical Center:
Metastatic
Refractory
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Colonic Diseases
Intestinal Diseases
Rectal Diseases
Everolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs