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OpenTrials
Completed

NCT Number: NCT00478634

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

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Colorectal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Neoplasms, Colorectal Rectal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Highlands Oncology Group, Fayetteville, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAD001, Cetuximab, Irinotecan

Drug

Primary outcomes

  1. Dose Limiting Toxicities

    Time frame: at end of cycle 2

    each cycle was 21 days

Secondary outcomes

  1. Pharmacokinetics of RAD001, Irinotecan and SN-38

  2. Progressions Free Survival

  3. Overall Survival

  4. Objective Response Rate

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 25, 2007
Registry last updated
Nov 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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