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

November 1, 2012 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72701
        • Highlands Oncology Group
    • California
      • Bakersfield, California, United States, 93309
        • Comprehensive nBlood and Cancer Care
      • La Jolla, California, United States, 92037
        • UCSD - Moores Cancer Center
      • Los Angeles, California, United States, 90095
        • Comprehensive Cancer Care
      • Northridge, California, United States, 91325
        • North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
      • Redondo Beach, California, United States, 90277
        • Cancer Care Associates Medical Group, Inc.
    • Connecticut
      • Norwalk, Connecticut, United States, 06850
        • Norwalk Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20057
        • Gerogetown University Lombardi Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center
    • Illinois
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Staten Island, New York, United States, 10310
        • Richmond University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC School of Medicine
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18017
        • Oncology/Hematology Associates
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Drug: RAD001, Cetuximab, Irinotecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Limiting Toxicities
Time Frame: at end of cycle 2
each cycle was 21 days
at end of cycle 2

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

May 24, 2007

First Submitted That Met QC Criteria

May 24, 2007

First Posted (Estimate)

May 25, 2007

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001C2242

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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