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

A phase Ib/II multi-center, open-label, dose escalation study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in patients with BRAF mutant metastatic colorectal cancer

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002138-35-ES

Enrollment

162

Registered

2012-09-26

Start date

2012-11-07

Completion date

Unknown

Last updated

2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BRAF mutant metastatic colorectal cancer MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: BYL719 Product Code: BYL719 Pharmaceutical Form: Tablet INN or Proposed INN: BYL719 CAS Number: 1217486-61-7 Current Sponsor code: BYL719 Concentration unit: mg milligram(s) Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 37

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Phase Ib: To estimate the MTD and/or RP2D 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 2. To determine the PK profile 3. To assess anti-tumor activity 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 Ph II : Progression Free Survival;Timepoint(s) of evaluation of this end point: Phase Ib: 1.5 years Phase II : 2.5 years	—

Measure

Time frame

Main Objective: Phase Ib: To estimate the MTD and/or RP2D 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 2. To determine the PK profile 3. To assess anti-tumor activity 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 Ph II : Progression Free Survival;Timepoint(s) of evaluation of this end point: Phase Ib: 1.5 years Phase II : 2.5 years

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Secondary

Measure	Time frame
Secondary end point(s): 1. Incidence and severity of adverse events 2. Plasma concentration 3. Phase Ib/ II : a) Overall response rate b) Duration of response c) Time to response d) Overall survival Ph Ib : - Progression free survival 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 2. 1.5 years 3. Phase Ib/II a) 2.5 years b) 2.5 years c) baseline, 2 years d) 3 years Ph Ib : - 1.5 years Ph II : 3 years 4. 2.5 years	—

Measure

Time frame

Secondary end point(s): 1. Incidence and severity of adverse events 2. Plasma concentration 3. Phase Ib/ II : a) Overall response rate b) Duration of response c) Time to response d) Overall survival Ph Ib : - Progression free survival 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 2. 1.5 years 3. Phase Ib/II a) 2.5 years b) 2.5 years c) baseline, 2 years d) 3 years Ph Ib : - 1.5 years Ph II : 3 years 4. 2.5 years

—

Countries

Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Norway, Spain, United States

Contacts

Public ContactMargaret Vargo

Array BioPharma Inc.

margie.vargo@arraybiopharma.com+13033861485

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026