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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 (BEACON CRC)

This study is currently recruiting participants.
Verified October 2017 by Array BioPharma
Sponsor:
ClinicalTrials.gov Identifier:
NCT02928224
First Posted: October 10, 2016
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Merck KGaA
Pierre Fabre Medicament
Information provided by (Responsible Party):
Array BioPharma
August 16, 2016
October 10, 2016
November 1, 2017
August 2016
July 2019   (Final data collection date for primary outcome measure)
  • (Safety Lead-in) Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]
  • (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 [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  • (Safety Lead-in) Incidence of dose interruptions, dose modifications and discontinuations due to adverse events (AEs) [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  • (Phase 3) Overall Survival (OS) of Triplet Arm vs. Control Arm [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
Same as current
Complete list of historical versions of study NCT02928224 on ClinicalTrials.gov Archive Site
  • (Safety Lead-in) Response Rate (ORR) [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  • (Safety Lead-in) Duration of Response (DOR) [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  • (Safety Lead-in) Time to Response [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  • (Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm and Triplet Arm vs. Doublet Arm [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  • (Phase 3) Comparison of Progression-free Survival (PFS) in study arms [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  • (Phase 3) Comparison of Objective Response Rate (ORR) in study arms [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  • (Phase 3) Comparison of Duration of Response (DOR) in study arms [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  • (Phase 3) Comparison of Time to Response in study arms [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  • (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 [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  • (Phase 3) Comparison of the Quality of Life in study arms [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  • (Safety Lead-in) Evaluation of the area under the concentration-time curve (AUC) for cetuximab, encorafenib, binimetinib, and a metabolite of binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  • (Safety Lead-in) Evaluation of the maximum concentration (Cmax) for cetuximab, encorafenib, binimetinib, and a metabolite of binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  • (Safety Lead-in) Evaluation of the time of maximum observed concentration (Tmax) for cetuximab, encorafenib, binimetinib, and a metabolite of binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  • (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 [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
Same as current
Not Provided
Not Provided
 
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
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
BRAF V600E-mutant Metastatic Colorectal Cancer
  • Drug: Encorafenib
    Orally, once daily.
  • Drug: Binimetinib
    Orally, twice daily.
  • Drug: Cetuximab
    Standard of care.
  • Drug: Irinotecan
    Standard of care.
  • Drug: Folinic Acid
    Standard of care.
    Other Name: FA
  • Drug: 5-Fluorouracil
    Standard of care.
    Other Name: 5-FU
  • Experimental: Safety Lead-in, Triplet Arm
    Encorafenib + binimetinib + cetuximab.
    Interventions:
    • Drug: Encorafenib
    • Drug: Binimetinib
    • Drug: Cetuximab
  • Experimental: Doublet Arm
    Encorafenib + cetuximab.
    Interventions:
    • Drug: Encorafenib
    • Drug: Cetuximab
  • Active Comparator: Control Arm
    Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.
    Interventions:
    • Drug: Cetuximab
    • Drug: Irinotecan
    • Drug: Folinic Acid
    • Drug: 5-Fluorouracil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
645
July 2019
July 2019   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 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 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Array BioPharma, Inc. 303-381-6604 clinicaltrials@arraybiopharma.com
Australia,   Austria,   Belgium,   Brazil,   Canada,   Czechia,   Denmark,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Russian Federation,   Spain,   Taiwan,   Turkey,   Ukraine,   United States
 
 
NCT02928224
ARRAY-818-302
2015-005805-35 ( EudraCT Number )
Yes
Not Provided
Not Provided
Array BioPharma
Array BioPharma
  • Merck KGaA
  • Pierre Fabre Medicament
Study Director: Array BioPharma, Inc. 303-381-6604
Array BioPharma
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP