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
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
1 other identifier
interventional
19
1 country
16
Brief Summary
This study will assess the safety of RAD001 when given together with cetuximab and irinotecan
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 colorectal-cancer
Started May 2007
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 24, 2007
CompletedFirst Posted
Study publicly available on registry
May 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedNovember 2, 2012
November 1, 2012
2.3 years
May 24, 2007
November 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dose Limiting Toxicities
each cycle was 21 days
at end of cycle 2
Secondary Outcomes (4)
Pharmacokinetics of RAD001, Irinotecan and SN-38
Progressions Free Survival
Overall Survival
Objective Response Rate
Study Arms (2)
A1: RAD001 + cetuximab + irinotecan
EXPERIMENTALRAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v.
B1 dose: RAD001 + cetuximab + irinotecan
EXPERIMENTALRAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Highlands Oncology Group
Fayetteville, Arkansas, 72701, United States
Comprehensive nBlood and Cancer Care
Bakersfield, California, 93309, United States
UCSD - Moores Cancer Center
La Jolla, California, 92037, United States
Comprehensive Cancer Care
Los Angeles, California, 90095, United States
North Valley Hematology/Oncology Medical Group: The Thomas & Dorothy Leavey Cancer Center
Northridge, California, 91325, United States
Cancer Care Associates Medical Group, Inc.
Redondo Beach, California, 90277, United States
Norwalk Hospital
Norwalk, Connecticut, 06850, United States
Gerogetown University Lombardi Cancer Center
Washington D.C., District of Columbia, 20057, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612, United States
Oncology Specialists
Park Ridge, Illinois, 60068, United States
Nevada Cancer Institute
Las Vegas, Nevada, 89135, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Richmond University Medical Center
Staten Island, New York, 10310, United States
UNC School of Medicine
Chapel Hill, North Carolina, 27599, United States
Oncology/Hematology Associates
Bethlehem, Pennsylvania, 18017, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2007
First Posted
May 25, 2007
Study Start
May 1, 2007
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 2, 2012
Record last verified: 2012-11