A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-Line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Mestastatic Colorectal Cancer

This study is currently recruiting participants.

Verified by Novartis, November 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00478634

Purpose

This study will assess the safety of RAD001 when given together with cetuximab and irinotecan

Condition	Intervention	Phase
Colorectal Cancer Colorectal Carcinoma Colorectal Tumors Neoplasms, Colorectal	Drug: RAD001, Cetuximab, Irinotecan	Phase I

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Irinotecan Irinotecan hydrochloride Bevacizumab Everolimus Cetuximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Multicenter Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-Line Therapy After FOLFOX (or XELOX) Plus Bevacizumab (if Given as Part of Local Standard Practice) in Patient With Metastatic Colorectal Adenocarcinoma

Further study details as provided by Novartis:

Primary Outcome Measures:

Dose Limiting Toxicities

Secondary Outcome Measures:

Pharmacokinetics of RAD001, Irinotecan and SN-38 Progressions Free Survival Overall Survival Objective Response Rate

Estimated Enrollment:	80
Study Start Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

Age ≥ 18 years old and ≤ 65 years old.
Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
Patients with a WHO performance status of 0 or 1.

Exclusion criteria

Patients with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
Patients who are homozygous for the UGT1A1*28 allele as determined by sequencing.
Patients who have received previous irinotecan-based therapy.
Prior treatment with an mTOR inhibitor.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478634

Contacts

Contact: Novartis

862 778 8300

Locations

United States, California
	Recruiting
La Jolla, California, United States, 92037
	Recruiting
Redondo Beach, California, United States, 90277
	Recruiting
Bakersfield, California, United States, 93309
	Recruiting
Los Angeles, California, United States, 90095
	Recruiting
Northridge, California, United States, 91325
United States, Connecticut
	Recruiting
Norwalk, Connecticut, United States, 06850
United States, Florida
	Recruiting
Tampa, Florida, United States, 33612
United States, Nevada
	Recruiting
Las Vegas, Nevada, United States, 89135
United States, New York
	Recruiting
Buffalo, New York, United States, 14263
United States, North Carolina
	Recruiting
Chapel Hill, North Carolina, United States, 27599

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Metastatic Colorectal Cancer This link exits the ClinicalTrials.gov site

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRAD001C2242
Study First Received:	May 24, 2007
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00478634
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Novartis:

Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

Study placed in the following topic categories:

Everolimus
Digestive System Neoplasms
Gastrointestinal Diseases
Cetuximab
Colonic Diseases
Irinotecan
Bevacizumab
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Carcinoma
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Immunosuppressive Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009