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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)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02928224
Recruitment Status : Active, not recruiting
First Posted : October 10, 2016
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
Merck KGaA, Darmstadt, Germany
Pierre Fabre Medicament
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Array BioPharma

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.

Condition or disease Intervention/treatment Phase
BRAF V600E-mutant Metastatic Colorectal Cancer Drug: Encorafenib Drug: Binimetinib Drug: Cetuximab Drug: Irinotecan Drug: Folinic Acid Drug: 5-Fluorouracil Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 2016
Actual Primary Completion Date : February 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Safety Lead-in, Triplet Arm
Encorafenib + binimetinib + cetuximab.
Drug: Encorafenib
Orally, once daily.

Drug: Binimetinib
Orally, twice daily.

Drug: Cetuximab
Standard of care.

Experimental: Doublet Arm
Encorafenib + cetuximab.
Drug: Encorafenib
Orally, once daily.

Drug: Cetuximab
Standard of care.

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




Primary Outcome Measures :
  1. (Safety Lead-in) Incidence of dose-limiting toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]
  2. (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) ]
  3. (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) ]
  4. (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) ]
  5. (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 [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]

Secondary Outcome Measures :
  1. (Safety Lead-in) Response Rate (ORR) [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  2. (Safety Lead-in) Duration of Response (DOR) [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  3. (Safety Lead-in) Time to Response [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  4. (Safety Lead-in) Progression-free Survival (PFS) [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  5. (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) ]
  6. (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) ]
  7. (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) ]
  8. (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) ]
  9. (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) ]
  10. (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) ]
  11. (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) ]
  12. (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 ]
  13. (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 ]
  14. (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 ]
  15. (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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928224


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Locations
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United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
Compassionate Cancer Care Medical Group, Inc. - Corona
Corona, California, United States, 92879
City of Hope - Comprehensive Cancer Center
Duarte, California, United States, 91010
Compassionate Care Research Group, Inc.
Fountain Valley, California, United States, 92708
St. Jude Heritage Healthcare
Fullerton, California, United States, 92835
University of Southern California (USC) Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Compassionate Cancer Care Medical Group
Riverside, California, United States, 92501
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Broward General Medical Center
Fort Lauderdale, Florida, United States, 33316
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30332
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Illinois Cancer Center
Peoria, Illinois, United States, 61615
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
Baptist Health Cancer Center
New Albany, Indiana, United States, 47150
United States, Iowa
University of Iowa Health Care - University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Maryland
John Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital (MGH)
Boston, Massachusetts, United States, 02215
United States, Michigan
St. Joseph Mercy Hospital
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Washington University
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock
Lebanon, New Hampshire, United States, 03756
United States, New Mexico
New Mexico Cancer Care
Albuquerque, New Mexico, United States, 87131
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Ohio
Gabrail Cancer CTR Research
Canton, Ohio, United States, 44718
Cleveland Clinic Taussig
Cleveland, Ohio, United States, 44195
Toledo Clinic Cancer Center
Toledo, Ohio, United States, 43623
United States, Oregon
Oregon Health and Science University Knight Cancer Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Vanderbilt Ingram Cancer CTR
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
Baylor Scott & White Health
Temple, Texas, United States, 76508
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Medical Oncology Associates, P.S.
Spokane, Washington, United States, 99208
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Argentina
Array BioPharma Investigative Site
Pergamino, Buenos Aires, Argentina, B2700CPM
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Córdoba, Cordoba, Argentina, X5004FHP
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Santa Rosa, La Pampa, Argentina, L6300EAN
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San Miguel De Tucumán, Tucuman, Argentina, T400GTB
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La Rioja, Argentina, 5300
Australia, New South Wales
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Darlinghurst, New South Wales, Australia, 2010
Australia, South Australia
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Adelaide, South Australia, Australia, 5042
Australia, Victoria
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East Bentleigh, Victoria, Australia, 3165
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Heidelberg, Victoria, Australia, 3084
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Parkville, Victoria, Australia, 3000
Australia
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Adelaide, Australia, 5011
Austria
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Steyr, Oberösterreich, Austria, 4400
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Wels, Oberösterreich, Austria, 4600
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Vienna, Austria, 1090
Belgium
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Bonheiden, Antwerpen, Belgium, 2820
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Edegem, Antwerp, Belgium
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Charleroi, Hainaut, Belgium, 6000
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Verviers, Liege, Belgium, 4800
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Libramont-Chevigny, Luxembourg, Belgium, 6800
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Gent, Oost-Vlaanderen, Belgium, 9000
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Brugge, West-Vlaanderen, Belgium, 8000
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Roeselare, West-Vlaanderen, Belgium, 8800
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Leuven, Belgium
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Liège, Belgium, 4000
Brazil
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Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-14
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Belo Horizonte, Minas Gerais, Brazil, 30130-090
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Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
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Lajeado, Rio Grande Do Sul, Brazil, 95900-000
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Pelotas, Rio Grande Do Sul, Brazil, 96015-280
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Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
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Porto Alegre, Rio Grande Do Sul, Brazil, 90470-340
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Itajaí, Santa Catarina, Brazil, 88301-220
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São Paulo, Sao Jose Do Rio Preto, Brazil, 15090-000
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Barretos, São Paulo, Brazil, 14784-400
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Santo André, São Paulo, Brazil, 09060-650
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Sorocaba, São Paulo, Brazil, 18030-200
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Passo Fundo, Brazil, RS 99010-080
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Pôrto Alegre, Brazil, RS 90470-340
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São Paulo, Brazil, 01236-030
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Montréal, Quebec, Canada, H3T 1M5
Canada
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Toronto, Canada, M5G 1X5
Chile
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Temuco, Araucanía, Chile, 4810469
Czechia
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Brno, Brno-město, Czechia, 656 53
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Hradec Králové, Královéhradecký Kraj, Czechia, 500 05
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Olomouc, Czechia, 779 00
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Praha, Czechia, 18081
Denmark
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Odense, South Denmark, Denmark, DK-5000
France
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Reims, Cedex, France, 51092
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Villejuif, Il-de-France, France, 94805
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Lyon, Rhone, France, 69373
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Avignon, Vaucluse, France, 84000
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Besançon, France, 25030
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Brest, France, 29609
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La Tronche, France, 38700
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Lyon, France, 69008
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Montpellier, France, 34298
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Paris, France, 75908
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Périgueux, France, 24004
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Toulouse, France, 31059
Germany
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Ulm, Baden-Württemberg, Germany, 89081
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München, Bayern, Germany, 81377
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Schweinfurt, Bayern, Germany, 97422
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Hannöver, Niedersachsen, Germany, 30625
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Oldenburg, Niedersachsen, Germany, 26133
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Essen, Nordrhein-Westfalen, Germany, 45136
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Essen, Nordrhein-Westfalen, Germany, 45147
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Worms, Rheinland-Pfalz, Germany, 67547
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Dresden, Sachsen, Germany, 01307
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Kiel, Schleswig-Holstein, Germany, 24105
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Tübingen, Württemberg, Germany, 72076
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Berlin, Germany, 13589
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Hamburg, Germany, 20249
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Mönchengladbach, Germany, 41063
Hungary
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Pécs, Baranya, Hungary, 7624
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Debrecen, Hajdú-Bihar, Hungary, 4032
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Kaposvár, Somogy, Hungary, H-7400
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Budapest, Hungary, 1032
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Budapest, Hungary, 1062
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Budapest, Hungary, H-1097
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Budapest, Hungary, H-1145
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Zalaegerszeg, Hungary, H-8900
Israel
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Beer Sheva, HaDarom, Israel, 84101
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Kfar Saba, HaMerkaz, Israel, 44281
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Petah Tikva, HaMerkaz, Israel, 4941492
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Ramat Gan, Hamerkaz, Israel, 52621
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Ashkelon, Israel, 7830604
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Jerusalem, Israel, 91120
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Tel Aviv, Israel, 64239
Italy
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Treviglio, Bergamo, Italy, 24047
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Monserrato, Cagliari, Italy, 09042
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Monza, Milano, Italy, 20900
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Milano, MI, Italy, 20133
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Aviano, Pordenone, Italy, 33081
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Ancona, Italy, 60126
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Bergamo, Italy, 24127
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Bologna, Italy, 40138
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Cremona, Italy, 26100
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Firenze, Italy, 50134
Array BioPharma Investigative Sites (2)
Milano, Italy, 20132
Array BioPharma Investigative Site
Milano, Italy, 20141
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Milano, Italy, 20162
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Modena, Italy, 41124
Array BioPharma Investigative Sites (2)
Napoli, Italy, 80131
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Padova, Italy, 35128
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Pisa, Italy, 56124
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Roma, Italy, 00133
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Roma, Italy, 00144
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Roma, Italy, 00152
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Rozzano, Italy, 20089
Japan
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Nagoya, Aichi, Japan, 464-8681
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Kashiwa, Chiba, Japan, 277-8577
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Sapporo, Haikodo, Japan, 060-8648
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Kanazawa, Isikawa, Japan, 920-8641
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Kawasaki, Kanagawa, Japan, 216-8511
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Yokohama, Kanagawa, Japan, 241-8515
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Amagasaki, Osaka, Japan, 660-8501
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Suita, Osaka, Japan, 565-0871
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Tsukiji, Tokyo, Japan, 104-0045
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Fukuoka, Japan, 811-1347
Korea, Republic of
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Busan, Busan Gwang'yeogsi, Korea, Republic of, 13620
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Anyang-si, Gyeonggido, Korea, Republic of, 14068
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Seongnam-si, Gyeonggido, Korea, Republic of, 13620
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Jeollanam-do, Jeonranamdo, Korea, Republic of, 58128
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Array BioPharma Investigative Site
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
Array BioPharma Investigative Site
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
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Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
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Seoul, Teugbyeolsi, Korea, Republic of, 06591
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Incheon, Korea, Republic of, 21565
Mexico
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Distrito Federal, Col Roma, Mexico, 6760
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México, Mexico, 06760
Netherlands
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Noord-Holland, Amsterdam, Netherlands
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Amhem, Gelderland, Netherlands, 6883
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Den Haag, Netherlands, 2545 CH
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Heidelberglaan, Netherlands
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Limburg, Netherlands, 6229 HX
Norway
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Oslo, Norway, N-0785
Poland
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Otwock, Mazowieckie, Poland, 05-400
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Warszawa, Mazowieckie, Poland, 03-291
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Brzozów, Podkarpackie, Poland, 36-200
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Elbląg, Warminsko-mazurskie, Poland, 82-300
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Poznan, Wielkopolskie, Poland, 61-485
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Krakow, Poland, 31-826
Russian Federation
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Obninsk, Kaluzhskaya Oblast', Russian Federation, 249036
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Kursk, Kurski Region, Russian Federation, 305035
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Chelyabinsk, Russian Federation, 454048
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Moscow, Russian Federation, 115478
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Saint Petersburg, Russian Federation, 197022
Spain
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Sabadell, Barcelona, Spain, 08208
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San Sebastián, Guipúzcoa, Spain, 20014
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Palma de Mallorca, Illes Balears, Spain, 07010
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Madrid, Sancchinarro, Spain, 28050
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Reus, Tarragona, Spain, 43201
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Barcelona, Spain, 08907
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Barcelona, Spain
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Burgos, Spain, 09005
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Córdoba, Spain, 14004
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Jaén, Spain, 23007
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Madrid, Spain, 28007
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Madrid, Spain, 28034
Arrray BioPharma Investigative Sites (2)
Madrid, Spain, 28040
Array BioPharma Investigative Site
Madrid, Spain, 28041
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Madrid, Spain, 28046
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Sevilla, Spain, 41013
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Valencia, Spain, 46009
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Valencia, Spain, 46014
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Valencia, Spain
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Zaragoza, Spain, 50009
Taiwan
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Taichung, Changhua, Taiwan, 500
Array BioPharma Investigative Site
Linkou, Taoyuan, Taiwan, 333
Array BioPharma Investigative Site
Kaohsiung, Taiwan, 807
Array BioPharma Investigative Site
Taichung, Taiwan, 404
Array BioPharma Investigative Site
Tainan, Taiwan, 70403
Array BioPharma Investigative Site
Taipei, Taiwan, 100
Turkey
Array BioPharma Investigative Site (2)
Ankara, Turkey, 06230
Array BioPharma Investigative Site
Bursa, Turkey, 16059
Array BioPharma Investigative Site
Edime, Turkey, 22030
Array BioPharma Investigative Site
İstanbul, Turkey, 34722
Array BioPharma Investigative Site
İzmir, Turkey, 35100
Array BioPharma Investigative Site
İzmir, Turkey, 35575
Array BioPharma Investigative Site
Malatya, Turkey, 44400
Ukraine
Array BioPharma Investigative Site
Dnipropetrovsk, Dnipropetrovs'ka Oblast', Ukraine, 49102
Array BioPharma Investigative Site
Vinnytsya, Vinnyts'ka Oblast', Ukraine, 21029
Array BioPharma Investigative Site
Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88000
Array BioPharma Investigative Site
Kyiv, Ukraine, 02096
United Kingdom
Array BioPharma Investigative Site
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
Array BioPharma Investigative Site
Hammersmith, London, United Kingdom, W6 8RF
Array BioPharma Investigative Site
Glasgow, Scotland, United Kingdom, G12 0YH
Array BioPharma Investigative Site
Guildford, Surrey, United Kingdom, GU2 7XX
Array BioPharma Investigative Site
London, United Kingdom, W12 0HS
Array BioPharma Investigative Site
London, United Kingdom, W1G 6AD
Array BioPharma Investigative Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Array BioPharma
Merck KGaA, Darmstadt, Germany
Pierre Fabre Medicament
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Array BioPharma, Inc. 303-381-6604

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT02928224     History of Changes
Other Study ID Numbers: ARRAY-818-302
2015-005805-35 ( EudraCT Number )
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Keywords provided by Array BioPharma:
Colorectal cancer
BRAF
BRAFV600E
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Folic Acid
Irinotecan
Fluorouracil
Cetuximab
Levoleucovorin
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Antidotes
Protective Agents