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

First Received: May 24, 2007 Last Updated: November 12, 2008 History of Changes

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 U 101440E Irinotecan hydrochloride Everolimus Cetuximab Bevacizumab

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

Additional Information:

Metastatic Colorectal Cancer This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CRAD001C2242
Study First Received:	May 24, 2007
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00478634 History of Changes
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
Immunologic Factors
Gastrointestinal Diseases
Cetuximab
Colonic Diseases
Irinotecan
Bevacizumab
Intestinal Diseases
Immunosuppressive Agents

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Colonic Diseases
Irinotecan
Rectal Diseases
Neoplasms by Site
Therapeutic Uses
Everolimus
Digestive System Neoplasms
Neoplasms by Histologic Type

Cetuximab
Enzyme Inhibitors
Intestinal Diseases
Immunosuppressive Agents
Intestinal Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Antineoplastic Agents, Phytogenic
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009