Study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in BRAF mutant metastatic colorectal cancer

Phase 1

• Conditions: BRAF mutant metastatic colorectal cancer; MedDRA version: 20.0Level: PTClassification code 10061451Term: Colorectal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002138-35-ES
• Lead Sponsor: Array BioPharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-26
• Last Update Posted: 13 November 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

- Metastatic colorectal cancer
- Progression after at least one prior standard of care regimen or be intolerant to irinotecan-based regimens
- Life expectancy >= 3 months
- ECOG performance status <= 1

Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 37

Exclusion Criteria

- Symptomatic or untreated leptomeningeal disease
- Symptomatic brain metastasis
- Patients with clinically manifested diabetes
- Acute or chronic pancreatitis
- Clinically significant cardiac disease

Other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified