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Phase II Trial of RAD001 in Refractory Colorectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00337545
First Posted: June 16, 2006
Last Update Posted: October 10, 2007
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.
Collaborator:
Novartis
Information provided by:
Swedish Medical Center
  Purpose
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 Intervention Phase
Colorectal Cancer Drug: RAD001 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Swedish Medical Center:

Enrollment: 22
Study Start Date: May 2006
Estimated Study Completion Date: April 2007
Detailed Description:
Study is completed and closed.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, Washington
Swedish Cancer Institute
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Swedish Medical Center
Novartis
Investigators
Principal Investigator: Philip Gold, M.D. Swedish Cancer Institute
  More Information

ClinicalTrials.gov Identifier: NCT00337545     History of Changes
Other Study ID Numbers: CRAD0012467
Swedish Cancer Institute 05128
First Submitted: June 15, 2006
First Posted: June 16, 2006
Last Update Posted: October 10, 2007
Last Verified: October 2007

Keywords provided by Swedish Medical Center:
Metastatic
Refractory

Additional relevant MeSH terms:
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
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents