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

Novartis

Status and phase: Completed; Phase 1

Conditions: Colorectal Carcinoma; Colorectal Tumors; Neoplasms, Colorectal; Colorectal Cancer

Treatments: Drug: RAD001, Cetuximab, Irinotecan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00478634

CRAD001C2242

Details and patient eligibility

About

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

Enrollment: 19 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

A1: RAD001 + cetuximab + irinotecan

Experimental group

Description:

RAD001 30mg weekly oral, 400mg/m2, loading i.v. (250mg/m2 for subsequent weekly dose i.v.), 350mg/m2 every 3 weeks i.v.

Treatment:

Drug: RAD001, Cetuximab, Irinotecan

B1 dose: RAD001 + cetuximab + irinotecan

Experimental group

Description:

RAD001 30mg weekly oral, 400mg/m2 loading i.v (250mg/m2 for subsequent weekly dose i.v.), 250mg/m2 every 3 weeks i.v.

Treatment:

Drug: RAD001, Cetuximab, Irinotecan