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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02928224




Registration number
NCT02928224
Ethics application status
Date submitted
16/08/2016
Date registered
10/10/2016
Date last updated
20/12/2019

Titles & IDs
Public title
Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Scientific title
A Multicenter, Randomized, Open-label, 3-Arm Phase 3 Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5- Fluorouracil (5-FU)/Folinic Acid (FA) /Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Secondary ID [1] 0 0
2015-005805-35
Secondary ID [2] 0 0
ARRAY-818-302
Universal Trial Number (UTN)
Trial acronym
BEACON CRC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
BRAF V600E-mutant Metastatic Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Encorafenib
Treatment: Drugs - Binimetinib
Treatment: Drugs - Cetuximab
Treatment: Drugs - Irinotecan
Treatment: Drugs - Folinic Acid
Treatment: Drugs - 5-Fluorouracil

Experimental: Safety Lead-in, Triplet Arm - Encorafenib + binimetinib + cetuximab.

Experimental: Doublet Arm - Encorafenib + cetuximab.

Active Comparator: Control Arm - Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.


Treatment: Drugs: Encorafenib
Orally, once daily.

Treatment: Drugs: Binimetinib
Orally, twice daily.

Treatment: Drugs: Cetuximab
Standard of care.

Treatment: Drugs: Irinotecan
Standard of care.

Treatment: Drugs: Folinic Acid
Standard of care.

Treatment: Drugs: 5-Fluorouracil
Standard of care.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
(Safety Lead-in) Incidence of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Cycle 1 (up to 28 days)
Primary outcome [2] 0 0
(Safety Lead-in) Incidence and severity of adverse events (AEs) and changes in clinical laboratory parameters, vital signs, electrocardiograms (ECGs), echocardiogram (ECHO)/multi-gated acquisition (MUGA) scans and ophthalmic examinations
Timepoint [2] 0 0
Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
Primary outcome [3] 0 0
(Safety Lead-in) Incidence of dose interruptions, dose modifications and discontinuations due to adverse events (AEs)
Timepoint [3] 0 0
Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
Primary outcome [4] 0 0
(Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm
Timepoint [4] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Primary outcome [5] 0 0
(Phase 3) Response Rate (ORR) by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST), v1.1 of Triplet Arm vs. Control Arm
Timepoint [5] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [1] 0 0
(Safety Lead-in) Response Rate (ORR)
Timepoint [1] 0 0
Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
Secondary outcome [2] 0 0
(Safety Lead-in) Duration of Response (DOR)
Timepoint [2] 0 0
Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
Secondary outcome [3] 0 0
(Safety Lead-in) Time to Response
Timepoint [3] 0 0
Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
Secondary outcome [4] 0 0
(Safety Lead-in) Progression-free Survival (PFS)
Timepoint [4] 0 0
Duration of safety lead-in, approximately 6 months (up to 28 days per cycle)
Secondary outcome [5] 0 0
(Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm and Triplet Arm vs. Doublet Arm
Timepoint [5] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [6] 0 0
(Phase 3) Comparison of Progression-free Survival (PFS) in study arms
Timepoint [6] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [7] 0 0
(Phase 3) Comparison of Objective Response Rate (ORR) in study arms
Timepoint [7] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [8] 0 0
(Phase 3) Comparison of Duration of Response (DOR) in study arms
Timepoint [8] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [9] 0 0
(Phase 3) Comparison of Time to Response in study arms
Timepoint [9] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [10] 0 0
(Phase 3) Incidence and severity of adverse events (AEs) and changes in clinical laboratory parameters, vital signs, electrocardiograms (ECGs), echocardiogram (ECHO)/multi-gated acquisition (MUGA) scans and ophthalmic examinations
Timepoint [10] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [11] 0 0
(Phase 3) Comparison of the Quality of Life in study arms
Timepoint [11] 0 0
Duration of Phase 3, approximately 6 months (up to 28 days per cycle)
Secondary outcome [12] 0 0
(Safety Lead-in) Evaluation of the area under the concentration-time curve (AUC) for cetuximab, encorafenib, binimetinib, and a metabolite of binimetinib
Timepoint [12] 0 0
Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2
Secondary outcome [13] 0 0
(Safety Lead-in) Evaluation of the maximum concentration (Cmax) for cetuximab, encorafenib, binimetinib, and a metabolite of binimetinib
Timepoint [13] 0 0
Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2
Secondary outcome [14] 0 0
(Safety Lead-in) Evaluation of the time of maximum observed concentration (Tmax) for cetuximab, encorafenib, binimetinib, and a metabolite of binimetinib
Timepoint [14] 0 0
Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2
Secondary outcome [15] 0 0
(Safety Lead-in) Evaluation of the steady-state concentration measured just before the next dose of study drug (Ctrough) for cetuximab, encorafenib, binimetinib, and a metabolite of binimetinib
Timepoint [15] 0 0
Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2

Eligibility
Key inclusion criteria
Key

- Age = 18 years at time of informed consent

- Histologically- or cytologically-confirmed CRC that is metastatic

- Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any
time prior to Screening or by the central laboratory

- Progression of disease after 1 or 2 prior regimens in the metastatic setting

- Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1

- Adequate bone marrow, cardiac, kidney and liver function

- Able to take oral medications

- Female patients are either postmenopausal for at least 1 year, are surgically sterile
for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy
from screening through follow-up if of childbearing potential

- Males must agree to take appropriate precautions to avoid fathering a child from
screening through follow-up

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab, panitumumab or other
EGFR inhibitors

- Prior irinotecan hypersensitivity or toxicity that would suggest an inability to
tolerate irinotecan 180 mg/m2 every 2 weeks

- Symptomatic brain metastasis or leptomeningeal disease

- History or current evidence of retinal vein occlusion or current risk factors for
retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of
hyperviscosity or hypercoagulability syndromes)

- Known history of acute or chronic pancreatitis

- History of chronic inflammatory bowel disease or Crohn's disease requiring medical
intervention (immunomodulatory or immunosuppressive medications or surgery) =12 months
prior to randomization

- Uncontrolled blood pressure despite medical treatment

- Impaired GI function or disease that may significantly alter the absorption of
encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting,
malabsorption syndrome, small bowel resection with decreased intestinal absorption)

- Concurrent or previous other malignancy within 5 years of study entry, except cured
basal or squamous cell skin cancer, superficial bladder cancer, prostate
intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or
indolent malignancy

- History of thromboembolic or cerebrovascular events = 6 months prior to starting study
treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein
thrombosis or pulmonary emboli

- Concurrent neuromuscular disorder that is associated with the potential of elevated CK
(e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis,
spinal muscular atrophy)

- Residual CTCAE = Grade 2 toxicity from any prior anticancer therapy, with the
exception of Grade 2 alopecia or Grade 2 neuropathy

- Known history of HIV infection

- Active hepatitis B or hepatitis C infection

- Known history of Gilbert's syndrome

- Known contraindication to receive cetuximab or irinotecan at the planned doses

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Array BioPharma Investigative Site - Darlinghurst
Recruitment hospital [2] 0 0
Array BioPharma Investigative Site - Adelaide
Recruitment hospital [3] 0 0
Array BioPharma Investigative Site - East Bentleigh
Recruitment hospital [4] 0 0
Array BioPharma Investigative Site - Heidelberg
Recruitment hospital [5] 0 0
Array BioPharma Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
5042 - Adelaide
Recruitment postcode(s) [3] 0 0
3165 - East Bentleigh
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3000 - Parkville
Recruitment postcode(s) [6] 0 0
5011 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
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California
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United States of America
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Colorado
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Connecticut
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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Iowa
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United States of America
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Kansas
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Argentina
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Tucuman
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La Rioja
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Rheinland-Pfalz
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Germany
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Sachsen
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Schleswig-Holstein
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Württemberg
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Hamburg
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Mönchengladbach
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Baranya
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Bologna
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Gelderland
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Den Haag
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Heidelberglaan
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Limburg
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Norway
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Oslo
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Mazowieckie
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Warminsko-mazurskie
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Wielkopolskie
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Poland
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Krakow
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Russian Federation
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Russian Federation
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Chelyabinsk
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Burgos
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Córdoba
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Sevilla
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Valencia
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Spain
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Zaragoza
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Changhua
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Taiwan
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Taoyuan
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Turkey
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Ankara
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Bursa
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Turkey
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Edime
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Istanbul
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Izmir
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Turkey
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Malatya
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Ukraine
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Dnipropetrovs'ka Oblast'
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Ukraine
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Vinnyts'ka Oblast'
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Ukraine
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Zakarpats'ka Oblast'
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Ukraine
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Kyiv
Country [170] 0 0
United Kingdom
State/province [170] 0 0
Aberdeenshire
Country [171] 0 0
United Kingdom
State/province [171] 0 0
London
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Scotland
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Surrey
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Array BioPharma
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck KGaA, Darmstadt, Germany
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Pierre Fabre Medicament
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/Industry
Name [3] 0 0
Ono Pharmaceutical Co. Ltd
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib +
cetuximab plus or minus binimetinib versus Investigator's choice of either
irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose
disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study
contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib +
binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.
Trial website
https://clinicaltrials.gov/show/NCT02928224
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Array BioPharma, Inc.
Address 0 0
303-381-6604
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications