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

• Register: EUCTR
• Last refreshed on: 30 April 2019
• Main ID: EUCTR2012-002138-35-BE
• Date of registration: 06/11/2013
• Prospective Registration: Yes
• Primary sponsor: Array BioPharma Inc.
• Public title: Study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in BRAF mutant metastatic colorectal cancer
• Scientific title: 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
• Date of first enrolment: 05/05/2014
• Target sample size: 162
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002138-35
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Margaret Vargo
• Affiliation: Array BioPharma Inc.

• Name: Margaret Vargo
• Affiliation: Array BioPharma Inc.

Key inclusion & exclusion 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 = 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

BRAF mutant metastatic colorectal cancer
MedDRA version: 18.1 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]

Intervention(s)

Product Name: BYL719
Product Code: BYL719
Pharmaceutical Form: Tablet
CAS Number: 1217486-61-7
Current Sponsor code: BYL719
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: BYL719
Product Code: BYL719
Pharmaceutical Form: Tablet
CAS Number: 1217486-61-7
Current Sponsor code: BYL719
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: BYL719
Product Code: BYL719
Pharmaceutical Form: Tablet
CAS Number: 1217486-61-7
Current Sponsor code: BYL719
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: Erbitux
Product Name: cetuximab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CETUXIMAB
CAS Number: 205923-56-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-

Product Name: LGX818
Product Code: LGX818
Pharmaceutical Form: Capsule, hard
Current Sponsor code: LGX818
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-

Product Name: LGX818
Product Code: LGX818
Pharmaceutical Form: Capsule, hard
Current Sponsor code: LGX818
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu

Primary Outcome(s)

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

Timepoint(s) of evaluation of this end point: Phase Ib: 1.5 years
Phase II : 2.5 years

Primary end point(s): Ph Ib : incidence rate of dose-limiting toxicities
Ph II : Progression Free Survival

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

Secondary Outcome(s)

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

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

Ph II : Overall survival

4. Baseline molecular status of potential predictive markers of tumor response or resistance

Secondary ID(s)

2012-002138-35-ES

CLGX818X2103

Source(s) of Monetary Support

Array BioPharma Inc

Ethics review

Status: Approved
Approval date:
Contact: