We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    beacon crc
Previous Study | Return to List | Next Study

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
  Purpose
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 Intervention Phase
BRAF V600E-mutant Metastatic Colorectal Cancer Drug: Encorafenib Drug: Binimetinib Drug: Cetuximab Drug: Irinotecan Drug: Folinic Acid Drug: 5-Fluorouracil Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Array BioPharma:

Primary Outcome Measures:
  • (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) ]

Secondary Outcome Measures:
  • (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 ]

Estimated Enrollment: 645
Study Start Date: August 2016
Estimated Study Completion Date: July 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: Array BioPharma, Inc. 303-381-6604 clinicaltrials@arraybiopharma.com

  Hide Study Locations
Locations
United States, California
Compassionate Cancer Care Medical Group, Inc. - Corona Recruiting
Corona, California, United States, 92879
Contact    951-371-2411      
Principal Investigator: Haresh Jhangiani, MD         
City of Hope - Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact    626-256-4673 ext 63087      
Principal Investigator: Marwan Fakih, MD         
Compassionate Care Research Group, Inc. Recruiting
Fountain Valley, California, United States, 92708
Contact: Barbara Lepthien    714-698-0300      
Principal Investigator: Peyman Salimi-Tari, MD         
University of Southern California (USC) Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Marile Garcia Leiva    323-865-3000    Marile.GarciaLeiva@med.usc.edu   
Principal Investigator: Heinz-Josef Lenz, MD         
Compassionate Cancer Care Medical Group Recruiting
Riverside, California, United States, 92501
Contact: Corina King    951-276-2760      
Principal Investigator: Brian Choi, MD         
United States, Colorado
University of Colorado Hospital - Anschutz Cancer Pavilion Recruiting
Aurora, Colorado, United States, 80045
Contact: Amy Szilard    720-848-0702      
Principal Investigator: Christopher Lieu, MD         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06510
Contact: Kamil Sadowski    203-785-6661      
Principal Investigator: Howard Hochster, MD         
United States, Florida
Broward General Medical Center Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Donna Stefinsky    954-712-3949      
Principal Investigator: Archana Maini, MD         
Sylvester Comprehensive Cancer Center Recruiting
Miami, Florida, United States, 33136
Contact: Eduardo Cianferra    305-243-1139      
Principal Investigator: Agustin Pimentel, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Lyndsee Zhang (Geyer)    773-702-0819    Lzhang3@bsd.uchicago.edu   
Principal Investigator: Manish Sharma, MD         
Illinois Cancer Center Recruiting
Peoria, Illinois, United States, 61615
Contact: Carrie Geoffroy    309-243-3605      
Principal Investigator: Francois Geoffroy, MD         
Carle Cancer Center Recruiting
Urbana, Illinois, United States, 61801
Contact: Joshua Ward    217-383-4011      
Principal Investigator: James Egner, MD         
United States, Indiana
Baptist Health Cancer Center Recruiting
New Albany, Indiana, United States, 47150
Contact: Tasha Dotson    812-981-6236      
Principal Investigator: Naveed Chowhan, MD         
United States, Iowa
University of Iowa Health Care - University of Iowa Hospital Recruiting
Iowa City, Iowa, United States, 52242
Contact: Michelle Arnold, RN    319-356-2778      
Principal Investigator: Daniel Berg, MD         
United States, Kansas
University of Kansas Cancer Center Recruiting
Westwood, Kansas, United States, 66205
Contact: Kayla Thompson    913-588-1886    kthompson8@kumc.edu   
Principal Investigator: Raed Al-Rajabi, MD         
United States, Maryland
John Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Candace Griffin    410-502-5568      
Principal Investigator: Nilofer Azad, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Christopher Graham, RN    617-632-5960    Christopher_Graham@dfci.harvard.edu   
Principal Investigator: Kimmie Ng, MD         
United States, Michigan
St. Joseph Mercy Hospital Recruiting
Ypsilanti, Michigan, United States, 48197
Contact: Ann Novak, RN    734-712-5674      
Principal Investigator: Philip Stella, MD         
United States, Missouri
Saint Louis University Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Debra King    314-577-8854    kingdl@slu.edu   
Principal Investigator: Nishant Poddar, MD         
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Katrina Pedersen, MD    314-362-9115    kpedersen@wustl.edu   
Principal Investigator: Katrina Pedersen, MD         
United States, New Mexico
New Mexico Cancer Care Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kim Steinberg, RN    505-272-4946    KimSteinberg@salud.unm.edu   
Principal Investigator: Vi Chiu, MD         
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Jonathan Hersch    646-888-1377      
Principal Investigator: Rona Yaeger, MD         
United States, Ohio
Gabrail Cancer CTR Research Recruiting
Canton, Ohio, United States, 44718
Contact: Brittany Dunn    330-492-3345 ext 213    bdunn@gabrailcancercenter.com   
Principal Investigator: Nashat Y Gabrail, MD         
Cleveland Clinic Taussig Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alok Khorana    216-636-2690      
Principal Investigator: Alok Khorana, MD         
Toledo Clinic Cancer Center Recruiting
Toledo, Ohio, United States, 43623
Contact: Pam Shoup    419-214-4236      
Principal Investigator: Rex Mowat, MD         
United States, Oregon
Oregon Health and Science University Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Knight Clinical Trials Information Line    503-494-1080      
Principal Investigator: Gina Vaccaro, MD         
United States, Tennessee
Vanderbilt Ingram Cancer CTR Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanderbilt-Ingram Services for Timely Access    800-811-8480      
Principal Investigator: Dana Cardin, MD         
United States, Texas
MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Mary Brimer    713-792-2828      
Principal Investigator: Van Morris, MD         
United States, Washington
Virginia Mason Medical Center Recruiting
Seattle, Washington, United States, 98101
Contact: Ibrahim Abukenda    206-341-8993      
Principal Investigator: Bruce Lin, MD         
Medical Oncology Associates, P.S. Recruiting
Spokane, Washington, United States, 99208
Contact    509-462-2275      
Principal Investigator: Chaudhry Arvind, MD         
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: UWCCC Cancer Connect    800-622-8922    cancerconnect@uwcarbone.wisc.edu   
Principal Investigator: Dustin Deming, MD         
Australia, New South Wales
Array BioPharma Investigative Site Recruiting
Darlinghurst, New South Wales, Australia, 2010
Australia, South Australia
Array BioPharma Investigative Site Recruiting
Adelaide, South Australia, Australia, 5042
Australia, Victoria
Array BioPharma Investigative Site Recruiting
East Bentleigh, Victoria, Australia, 3165
Array BioPharma Investigative Site Recruiting
Heidelberg, Victoria, Australia, 3084
Array BioPharma Investigative Site Recruiting
Parkville, Victoria, Australia, 3000
Australia
Array BioPharma Investigative Site Recruiting
Adelaide, Australia, 5011
Austria
Array BioPharma Investigative Site Recruiting
Wels, Oberösterreich, Austria, 4600
Array BioPharma Investigative Site Recruiting
Vienna, Austria, 1090
Belgium
Array BioPharma Investigative Site Recruiting
Bonheiden, Antwerpen, Belgium, 2820
Array Biopharma Investigative Site Recruiting
Edegem, Antwerp, Belgium
Array BioPharma Investigative Site Recruiting
Charleroi, Hainaut, Belgium, 6000
Array BioPharma Investigative Site Recruiting
Verviers, Liege, Belgium, 4800
Array BioPharma Investigative Site Recruiting
Libramont-Chevigny, Luxembourg, Belgium, 6800
Array BioPharma Investigative Site Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Array BioPharma Investigative Site Recruiting
Brugge, West-Vlaanderen, Belgium, 8000
Array BioPharma Investigative Site Recruiting
Roeselare, West-Vlaanderen, Belgium, 8800
Array BioPharma Investigative Site Recruiting
Leuven, Belgium
Array BioPharma Investigative Sites (2) Recruiting
Liège, Belgium, 4000
Brazil
Array BioPharma Investigative Site Recruiting
Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29308-14
Array BioPharma Investigative Site Recruiting
Belo Horizonte, Minas Gerais, Brazil, 30130-090
Array BioPharma Investigative Site Recruiting
Caxias do Sul, Rio Grande do Sul, Brazil, 95070-560
Array BioPharma Investigative Site Recruiting
Lajeado, Rio Grande do Sul, Brazil, 95900-000
Array BioPharma Investigative Site Recruiting
Pelotas, Rio Grande do Sul, Brazil, 96015-280
Array BioPharma Investigative Site Recruiting
Itajaí, Santa Catarina, Brazil, 88301-220
Array BioPharma Investigative Site Recruiting
São Paulo, Sao Jose do Rio Preto, Brazil, 15090-000
Array BioPharma Investigative Site Recruiting
Santo André, São Paulo, Brazil, 09060-650
Array BioPharma Investigative Site Recruiting
Sorocaba, São Paulo, Brazil, 18030-200
Array BioPharma Investigative Site Recruiting
Passo Fundo, Brazil, RS 99010-080
Array BioPharma Investigative Site Recruiting
Pôrto Alegre, Brazil, RS 90470-340
Array BioPharma Investigative Site Recruiting
São Paulo, Brazil, 01236-030
Canada, Ontario
Array BioPharma Investigative Site Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Array BioPharma Investigative Site Recruiting
Toronto, Ontario, Canada, M4N 3M5
Canada
Array BioPharma Investigative Site Recruiting
Toronto, Canada, M5G 1X5
Czechia
Array BioPharma Investigative Site Recruiting
Brno, Brno-město, Czechia, 656 53
Array BioPharma Investigative Site Recruiting
Hradec Králové, Královéhradecký kraj, Czechia, 500 05
Array BioPharma Investigative Site Recruiting
Olomouc, Czechia, 779 00
Array BioPharma Investigative Site Recruiting
Praha, Czechia, 18081
Denmark
Array BioPharma Investigative Site Recruiting
Odense, South Denmark, Denmark, DK-5000
Germany
Array BioPharma Investigative Site Recruiting
Ulm, Baden-Württemberg, Germany, 89081
Array BioPharma Investigative Site Recruiting
München, Bayern, Germany, 81377
Array BioPharma Investigative Site Recruiting
Schweinfurt, Bayern, Germany, 97422
Array BioPharma Investigative Site Recruiting
Hannöver, Niedersachsen, Germany, 30625
Array BioPharma Investigative Site Recruiting
Essen, Nordrhein-Westfalen, Germany, 45136
Array BioPharma Investigative Site Recruiting
Dresden, Sachsen, Germany, 01307
Array BioPharma Investigative Site Recruiting
Kiel, Schleswig-Holstein, Germany, 24105
Array BioPharma Investigative Site Recruiting
Tübingen, Württemberg, Germany, 72076
Array BioPharma Investigative Site Recruiting
Berlin, Germany, 13589
Array BioPharma Investigative Site Recruiting
Hamburg, Germany, 20249
Array BioPharma Investigative Site Recruiting
Mönchengladbach, Germany, 41063
Hungary
Array BioPharma Investigative Site Recruiting
Pécs, Baranya, Hungary, 7624
Array BioPharma Investigative Site Recruiting
Debrecen, Hajdú-Bihar, Hungary, 4032
Array BioPharma Investigative Site Recruiting
Kaposvár, Somogy, Hungary, H-7400
Array BioPharma Investigative Site Recruiting
Budapest, Hungary, 1032
Array BioPharma Investigative Site Recruiting
Budapest, Hungary, 1062
Arrray BioPharma Investigative Site Recruiting
Budapest, Hungary, H-1097
Array BioPharma Investigative Site Recruiting
Budapest, Hungary, H-1145
Array BioPharma Investigative Site Recruiting
Zalaegerszeg, Hungary, H-8900
Israel
Array BioPharma Investigative Site Recruiting
Beer Sheva, HaDarom, Israel, 84101
Array BioPharma Investigative Site Recruiting
Kfar Saba, HaMerkaz, Israel, 44281
Array BioPharma Investigative Site Recruiting
Petah Tikva, HaMerkaz, Israel, 4941492
Array BioPharma Investigative Site Recruiting
Ramat Gan, Hamerkaz, Israel, 52621
Array BioPharma Investigative Site Recruiting
Ashkelon, Israel, 7830604
Array BioPharma Investigative Site Recruiting
Jerusalem, Israel, 91120
Array BioPharma Investigative Site Recruiting
Tel Aviv, Israel, 64239
Italy
Array BioPharma Investigative Site Recruiting
Monza, Milano, Italy, 20900
Array BioPharma Investigative Site Recruiting
Milano, Italy, 20132
Array BioPharma Investigative Site Recruiting
Milano, Italy, 20141
Array BioPharma Investigative Site Recruiting
Modena, Italy, 41124
Array BioPharma Investigative Site Recruiting
Rozzano, Italy, 20089
Korea, Republic of
Array BioPharma Investigative Site Recruiting
Busan, Busan Gwang'yeogsi, Korea, Republic of, 13620
Array BioPharma Investigative Site Recruiting
Anyang-si, Gyeonggido, Korea, Republic of, 14068
Array BioPharma Investigative Site Recruiting
Seongnam-si, Gyeonggido, Korea, Republic of, 13620
Array BioPharma Investigative Site Recruiting
Jeollanam-do, Jeonranamdo, Korea, Republic of, 58128
Array BioPharma Investigative Site Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 02841
Array BioPharma Investigative Site Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080
Array BioPharma Investigative Site Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03722
Array BioPharma Investigative Site Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
Array BioPharma Investigative Site Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 06351
Array BioPharma Investigative Site Recruiting
Seoul, Seoul Teugbyeolsi, Korea, Republic of, 08308
Array BioPharma Investigative Site Recruiting
Seoul, Teugbyeolsi, Korea, Republic of, 06591
Array BioPharma Investigative Site Recruiting
Incheon, Korea, Republic of, 21565
Mexico
Array BioPharma Investigative Site Recruiting
Distrito Federal, Col Roma, Mexico, 6760
Array BioPharma Investigative Site Recruiting
México, Mexico, 06760
Netherlands
Array BioPharma Investigative Site Recruiting
Noord-Holland, Amsterdam, Netherlands
Array BioPharma Investigative Site Recruiting
Amhem, Gelderland, Netherlands, 6883
Array BioPharma Investigative Site Recruiting
Den Haag, Netherlands, 2545 CH
Array BioPharma Investigative Site Recruiting
Heidelberglaan, Netherlands
Array BioPharma Investigative Site Recruiting
Limburg, Netherlands, 6229 HX
Poland
Array BioPharma Investigative Site Recruiting
Otwock, Mazowieckie, Poland, 05-400
Array BioPharma Investigative Sites (2) Recruiting
Warszawa, Mazowieckie, Poland, 03-291
Array BioPharma Investigative Site Recruiting
Brzozów, Podkarpackie, Poland, 36-200
Array BioPharma Investigative Site Recruiting
Elbląg, Warminsko-mazurskie, Poland, 82-300
Array BioPharma Investigative Site Recruiting
Poznan, Wielkopolskie, Poland, 61-485
Array BioPharma Investigative Site Recruiting
Krakow, Poland, 31-826
Russian Federation
Array BioPharma Investigative Site Recruiting
Obninsk, Kaluzhskaya oblast', Russian Federation, 249036
Array BioPharma Investigative Site Recruiting
Kursk, Kurski Region, Russian Federation, 305035
Array BioPharma Investigative Site Recruiting
Chelyabinsk, Russian Federation, 454048
Array BioPharma Investigative Sites (2) Recruiting
Moscow, Russian Federation, 115478
Array BioPharma Investigative Site Recruiting
Saint Petersburg, Russian Federation, 197022
Spain
Array BioPharma Investigative Site Recruiting
Sabadell, Barcelona, Spain, 08208
Array BioPharma Investigative Site Recruiting
San Sebastián, Guipúzcoa, Spain, 20014
Array BioPharma Investigative Site Recruiting
Palma de Mallorca, Illes Balears, Spain, 07010
Array BioPharma Investigative Site Recruiting
Madrid, Sancchinarro, Spain, 28050
Array BioPharma Investigative Site Recruiting
Reus, Tarragona, Spain, 43201
Array BioPharma Investigative Site Recruiting
Barcelona, Spain, 08907
Array Biopharma Investigative Sites (2) Recruiting
Barcelona, Spain
Array BioPharma Investigative Site Recruiting
Burgos, Spain, 09005
Array BioPharma Investigative Site Recruiting
Córdoba, Spain, 14004
Array BioPharma Investigative Site Recruiting
Jaén, Spain, 23007
Array BioPharma Investigative Site Recruiting
Madrid, Spain, 28007
Array BioPharma Investigative Site Recruiting
Madrid, Spain, 28034
Arrray BioPharma Investigative Sites (2) Recruiting
Madrid, Spain, 28040
Array BioPharma Investigative Site Recruiting
Madrid, Spain, 28041
Array BioPharma Investigative Site Recruiting
Madrid, Spain, 28046
Array BioPharma Investigative Site Recruiting
Sevilla, Spain, 41013
Array BioPharma Investigative Site Recruiting
Valencia, Spain, 46009
Array BioPharma Investigative Site Recruiting
Valencia, Spain, 46014
Array BioPharma Investigative Site Recruiting
Valencia, Spain
Array BioPharma Investigative Site Recruiting
Zaragoza, Spain, 50009
Taiwan
Array BioPharma Investigative Site Recruiting
Taichung, Changhua, Taiwan, 500
Array BioPharma Investigative Site Recruiting
Linkou, Taoyuan, Taiwan, 333
Array BioPharma Investigative Site Recruiting
Kaohsiung, Taiwan, 807
Array BioPharma Investigative Site Recruiting
Taichung, Taiwan, 404
Array BioPharma Investigative Site Recruiting
Taipei, Taiwan, 100
Turkey
Array BioPharma Investigative Site Recruiting
Ankara, Turkey, 06230
Array BioPharma Investigative Site Recruiting
Bursa, Turkey, 16059
Array BioPharma Investigative Site Recruiting
Edime, Turkey, 22030
Array BioPharma Investigative Site Recruiting
İstanbul, Turkey, 34722
Array BioPharma Investigative Site Recruiting
İzmir, Turkey, 35100
Array BioPharma Investigative Site Recruiting
İzmir, Turkey, 35575
Array BioPharma Investigative Site Recruiting
Malatya, Turkey, 44400
Ukraine
Array BioPharma Investigative Site Recruiting
Dnipropetrovsk, Dnipropetrovs'ka Oblast', Ukraine, 49102
Array BioPharma Investigative Site Recruiting
Vinnytsya, Vinnyts'ka Oblast', Ukraine, 21029
Array BioPharma Investigative Site Recruiting
Uzhgorod, Zakarpats'ka Oblast', Ukraine, 88000
Array BioPharma Investigative Site Recruiting
Kyiv, Ukraine, 02096
Sponsors and Collaborators
Array BioPharma
Merck KGaA
Pierre Fabre Medicament
Investigators
Study Director: Array BioPharma, Inc. 303-381-6604
  More Information

Responsible Party: Array BioPharma
ClinicalTrials.gov Identifier: NCT02928224     History of Changes
Other Study ID Numbers: ARRAY-818-302
2015-005805-35 ( EudraCT Number )
First Submitted: August 16, 2016
First Posted: October 10, 2016
Last Update Posted: November 1, 2017
Last Verified: October 2017

Keywords provided by Array BioPharma:
Colorectal cancer
BRAF
BRAFV600E

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Camptothecin
Cetuximab
Fluorouracil
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes