Phase II Trial of RAD001 in Refractory Colorectal Cancer

Phase II Trial of RAD001 in Patients With Refractory Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: RAD001

Detailed Description

Study is completed and closed.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Swedish Medical Center
• Collaborators: Novartis
• Investigators: Principal Investigator: Philip Gold, M.D., Swedish Cancer Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2006
• Study Completion: April 1, 2007

Study Registration Dates

• First Submitted: June 15, 2006
• First Submitted That Met QC Criteria: June 15, 2006
• First Posted (Estimate): June 16, 2006

Study Record Updates

• Last Update Posted (Estimate): October 10, 2007
• Last Update Submitted That Met QC Criteria: October 5, 2007
• Last Verified: October 1, 2007

More Information

Terms related to this study

• Keywords: Refractory; Metastatic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: CRAD0012467; Swedish Cancer Institute 05128