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-NL
• Lead Sponsor: Array BioPharma Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-03
• Study Completion: 2019-02-12
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 156

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

Primary Outcome Measures

Name	Time	Method
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;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 ;Primary end point(s): Ph Ib : incidence rate of dose-limiting toxicities<br>Ph II : Progression Free Survival ;Timepoint(s) of evaluation of this end point: Phase Ib: 1.5 years<br>Phase II : 2.5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Incidence and severity of adverse events<br>2. Plasma concentration<br>3. <br>Phase Ib/II<br>a) Overall response rate<br>b) Duration of response<br>c) Time to response<br>d) Overall survival<br><br>Ph Ib : <br>- Progression free survival<br><br>Ph II : Overall survival<br><br>4. Baseline molecular status of potential predictive markers of tumor response or resistance;Timepoint(s) of evaluation of this end point: 1. 2.5 years<br>2. 1.5 years<br>3. <br>Phase Ib/II<br>a) 2.5 years<br>b) 2.5 years<br>c) baseline, 2 years<br>d) 3 years<br><br>Ph Ib :<br>- 1.5 years<br><br>Ph II : 3 years<br><br>4. 2.5 years