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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Pharmaceuticals )

ClinicalTrials.gov Identifier:

NCT00478634

First received: May 24, 2007

Last updated: November 1, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 24, 2007

Last Updated Date

November 1, 2012

Start Date ^ICMJE

May 2007

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Dose Limiting Toxicities [ Time Frame: at end of cycle 2 ] [ Designated as safety issue: Yes ]

each cycle was 21 days

Original Primary Outcome Measures ^ICMJE

Dose Limiting Toxicities

Change History

Complete list of historical versions of study NCT00478634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetics of RAD001, Irinotecan and SN-38 [ Designated as safety issue: No ]
Progressions Free Survival [ Designated as safety issue: No ]
Overall Survival [ Designated as safety issue: No ]
Objective Response Rate [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

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

Condition ^ICMJE

Colorectal Cancer
Colorectal Carcinoma
Colorectal Tumors
Neoplasms, Colorectal

Intervention ^ICMJE

Drug: RAD001, Cetuximab, Irinotecan

Study Arm (s)

Experimental: A1: RAD001 + cetuximab + irinotecan
RAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v.

Intervention: Drug: RAD001, Cetuximab, Irinotecan
Experimental: B1 dose: RAD001 + cetuximab + irinotecan
RAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.

Intervention: Drug: RAD001, Cetuximab, Irinotecan

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2009

Primary Completion Date

September 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00478634

Other Study ID Numbers ^ICMJE

CRAD001C2242

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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