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Phase II Trial of RAD001 in Refractory Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00337545
First received: June 15, 2006
Last updated: October 5, 2007
Last verified: October 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00337545     History of Changes
Other Study ID Numbers: CRAD0012467, Swedish Cancer Institute 05128
Study First Received: June 15, 2006
Last Updated: October 5, 2007
Health Authority: United States: Food and Drug Administration

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
Sirolimus
 Everolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 17, 2013