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 Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478634
• Other study ID #: CRAD001C2242
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2007
• Last updated: November 1, 2012
• Start date: May 2007
• Est. completion date: September 2009

Study information

• Verified date: November 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Carcinoma
• Colorectal Neoplasms
• Colorectal Tumors
• Neoplasms, Colorectal

Intervention

Drug:
• RAD001, Cetuximab, Irinotecan

Locations

Country	Name	City	State
United States	Arlington Cancer Center	Arlington	Texas
United States	Comprehensive nBlood and Cancer Care	Bakersfield	California
United States	Oncology/Hematology Associates	Bethlehem	Pennsylvania
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	UNC School of Medicine	Chapel Hill	North Carolina
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	UCSD - Moores Cancer Center	La Jolla	California
United States	Nevada Cancer Institute	Las Vegas	Nevada
United States	Comprehensive Cancer Care	Los Angeles	California
United States	North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center	Northridge	California
United States	Norwalk Hospital	Norwalk	Connecticut
United States	Oncology Specialists	Park Ridge	Illinois
United States	Cancer Care Associates Medical Group, Inc.	Redondo Beach	California
United States	Richmond University Medical Center	Staten Island	New York
United States	H. Lee Moffitt Cancer Center	Tampa	Florida
United States	Gerogetown University Lombardi Cancer Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicities	each cycle was 21 days	at end of cycle 2	Yes
Secondary	Pharmacokinetics of RAD001, Irinotecan and SN-38			No
Secondary	Progressions Free Survival			No
Secondary	Overall Survival			No
Secondary	Objective Response Rate			No