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: 14.1 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002138-35-NO
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-17
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• 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 = 2

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

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: Phase Ib: To estimate the MTD and/or RP2D <br> Phase II: To compare the efficacy of the dual (LGX818, Cetuximab) and triple (LGX818, BYL719, Cetuximab) combinations<br> ;<br> Secondary Objective: 1. To characterize the safety and tolerability <br> 2. To determine the PK profile <br> 3. To assess anti-tumor activity <br> 4. Phase II: To assess potential predictive markers of tumor response or resistance<br> ;<br> Primary end point(s): Ph Ib : incidence rate of dose-limiting toxicities<br> Ph II : Progression Free Survival<br> ;<br> Timepoint(s) of evaluation of this end point: Phase Ib: 1.5 years<br> Phase II : 2.5 years<br>