Phase II Trial of RAD001 in Refractory Colorectal Cancer

This study has been completed.

Sponsors and Collaborators:	Swedish Medical Center Novartis
Information provided by:	Swedish Medical Center
ClinicalTrials.gov Identifier:	NCT00337545

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 II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Everolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer

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

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

Keywords provided by Swedish Medical Center:

Metastatic
Refractory

Study placed in the following topic categories:

Everolimus
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Immunologic Factors

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009