Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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13 November 2017 |
Main ID: |
EUCTR2012-002138-35-ES |
Date of registration:
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26/09/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of LGX818 and cetuximab or LGX818, BYL719, and cetuximab in BRAF mutant metastatic colorectal cancer
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Scientific title:
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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:
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07/11/2012 |
Target sample size:
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162 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002138-35 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Australia
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Belgium
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Canada
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France
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Germany
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Italy
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Netherlands
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Norway
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Spain
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United States
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Contacts
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Name:
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Margaret Vargo
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Address:
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3200 Walnut Street
80301
Boulder
United States |
Telephone:
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+13033861485 |
Email:
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margie.vargo@arraybiopharma.com |
Affiliation:
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Array BioPharma Inc. |
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Name:
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Margaret Vargo
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Address:
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3200 Walnut Street
80301
Boulder
United States |
Telephone:
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+13033861485 |
Email:
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margie.vargo@arraybiopharma.com |
Affiliation:
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Array BioPharma Inc. |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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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) Concentration type: equal Concentration number: 10-
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) Concentration type: equal Concentration number: 50-
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) 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 INN or Proposed INN: LGX818 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 INN or Proposed INN: LGX818 Current Sponsor code: LGX818 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
Product Name: LGX818 Product Code: LGX818 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LGX818 Current Sponsor code: LGX818 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
Product Name: LGX818 Product Code: LGX818 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LGX818 Current Sponsor code: LGX818 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Erbitux Product Name: cetuximab Product Code: L01XC06 Pharmaceutical Form: Solution for infusion INN or Proposed INN: CETUXIMA
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Primary Outcome(s)
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Primary end point(s): Ph Ib : incidence rate of dose-limiting toxicities Ph II : Progression Free Survival
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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
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Timepoint(s) of evaluation of this end point: Phase Ib: 1.5 years Phase II : 2.5 years
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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
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Secondary Outcome(s)
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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
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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
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Secondary ID(s)
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CLGX818X2103
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Source(s) of Monetary Support
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Array BioPharma Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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