Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Conditions
Keywords
Colorectal Cancer, Colorectal Carcinoma, Colorectal Tumors, Neoplasms, Colorectal
Brief summary
This study will assess the safety of RAD001 when given together with cetuximab and irinotecan
Interventions
DRUGRAD001, Cetuximab, Irinotecan
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limiting Toxicities | at end of cycle 2 | each cycle was 21 days |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of RAD001, Irinotecan and SN-38 | — |
| Progressions Free Survival | — |
| Overall Survival | — |
| Objective Response Rate | — |
Countries
United States
Outcome results
None listed