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

Description

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.

Study Start Date

August, 01 2016

Estimated Completion Date

July 2019

Interventions

  • Drug: Irinotecan
  • Drug: Encorafenib
  • Drug: Cetuximab
  • Drug: 5-Fluorouracil
  • Drug: Binimetinib
  • Drug: Folinic Acid

Study ID

Array BioPharma -- ARRAY-818-302

Status

Recruiting

Trial ID

NCT02928224

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

645

Sponsor

Array BioPharma

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

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (116)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Christopher Graham RN 617-632-5960 Christopher_Graham@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Christopher Graham RN 617-632-5960 Christopher_Graham@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Christopher Graham RN 617-632-5960 Christopher_Graham@dfci.harvard.edu
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Christopher Graham RN 617-632-5960 Christopher_Graham@dfci.harvard.edu
Yale Cancer Center - New Haven, Connecticut 119.2 miles Kamil Sadowski 203-785-6661 None
Yale Cancer Center - New Haven, Connecticut 119.2 miles Kamil Sadowski 203-785-6661 None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Jonathan Hersch 646-888-1377 None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Jonathan Hersch 646-888-1377 None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Jonathan Hersch 646-888-1377 None
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Jonathan Hersch 646-888-1377 None
John Hopkins Hospital - Baltimore, Maryland 356.0 miles Candace Griffin 410-502-5568 None
John Hopkins Hospital - Baltimore, Maryland 356.0 miles Candace Griffin 410-502-5568 None
John Hopkins Hospital - Baltimore, Maryland 356.0 miles Candace Griffin 410-502-5568 None
John Hopkins Hospital - Baltimore, Maryland 356.0 miles Candace Griffin 410-502-5568 None
Cleveland Clinic Taussig - Cleveland, Ohio 544.9 miles Alok Khorana 216-636-2690 None
Cleveland Clinic Taussig - Cleveland, Ohio 544.9 miles Alok Khorana 216-636-2690 None
Cleveland Clinic Taussig - Cleveland, Ohio 544.9 miles Alok Khorana 216-636-2690 None
Cleveland Clinic Taussig - Cleveland, Ohio 544.9 miles Alok Khorana 216-636-2690 None
Gabrail Cancer CTR Research - Canton, Ohio 545.3 miles Brittany Dunn 330-492-3345 bdunn@gabrailcancercenter.com
Gabrail Cancer CTR Research - Canton, Ohio 545.3 miles Brittany Dunn 330-492-3345 bdunn@gabrailcancercenter.com
Gabrail Cancer CTR Research - Canton, Ohio 545.3 miles Brittany Dunn 330-492-3345 bdunn@gabrailcancercenter.com
Gabrail Cancer CTR Research - Canton, Ohio 545.3 miles Brittany Dunn 330-492-3345 bdunn@gabrailcancercenter.com
St Joseph Mercy Hospital - Ypsilanti, Michigan 640.8 miles Ann Novak RN 734-712-5674 None
St Joseph Mercy Hospital - Ypsilanti, Michigan 640.8 miles Ann Novak RN 734-712-5674 None
St Joseph Mercy Hospital - Ypsilanti, Michigan 640.8 miles Ann Novak RN 734-712-5674 None
St Joseph Mercy Hospital - Ypsilanti, Michigan 640.8 miles Ann Novak RN 734-712-5674 None
Toledo Clinic Cancer Center - Toledo, Ohio 646.5 miles Pam Shoup 419-214-4236 None
Toledo Clinic Cancer Center - Toledo, Ohio 646.5 miles Pam Shoup 419-214-4236 None
Toledo Clinic Cancer Center - Toledo, Ohio 646.5 miles Pam Shoup 419-214-4236 None
Toledo Clinic Cancer Center - Toledo, Ohio 646.5 miles Pam Shoup 419-214-4236 None
Baptist Health Cancer Center - New Albany, Indiana 825.4 miles Tasha Dotson 812-981-6236 None
Baptist Health Cancer Center - New Albany, Indiana 825.4 miles Tasha Dotson 812-981-6236 None
Baptist Health Cancer Center - New Albany, Indiana 825.4 miles Tasha Dotson 812-981-6236 None
Baptist Health Cancer Center - New Albany, Indiana 825.4 miles Tasha Dotson 812-981-6236 None
University of Chicago - Chicago, Illinois 848.0 miles Lyndsee Zhang Geyer 773-702-0819 Lzhang3@bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Lyndsee Zhang Geyer 773-702-0819 Lzhang3@bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Lyndsee Zhang Geyer 773-702-0819 Lzhang3@bsd.uchicago.edu
University of Chicago - Chicago, Illinois 848.0 miles Lyndsee Zhang Geyer 773-702-0819 Lzhang3@bsd.uchicago.edu
Carle Cancer Center - Urbana, Illinois 902.4 miles Joshua Ward 217-383-4011 None
Carle Cancer Center - Urbana, Illinois 902.4 miles Joshua Ward 217-383-4011 None
Carle Cancer Center - Urbana, Illinois 902.4 miles Joshua Ward 217-383-4011 None
University of Wisconsin Hospital and Clinics - Madison, Wisconsin 932.2 miles UWCCC Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu
University of Wisconsin Hospital and Clinics - Madison, Wisconsin 932.2 miles UWCCC Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu
University of Wisconsin Hospital and Clinics - Madison, Wisconsin 932.2 miles UWCCC Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu
University of Wisconsin Hospital and Clinics - Madison, Wisconsin 932.2 miles UWCCC Cancer Connect 800-622-8922 cancerconnect@uwcarbone.wisc.edu
Vanderbilt Ingram Cancer CTR - Nashville, Tennessee 944.2 miles VanderbiltIngram Services for Timely Access 800-811-8480 None
Vanderbilt Ingram Cancer CTR - Nashville, Tennessee 944.2 miles VanderbiltIngram Services for Timely Access 800-811-8480 None
Vanderbilt Ingram Cancer CTR - Nashville, Tennessee 944.2 miles VanderbiltIngram Services for Timely Access 800-811-8480 None
Vanderbilt Ingram Cancer CTR - Nashville, Tennessee 944.2 miles VanderbiltIngram Services for Timely Access 800-811-8480 None
Illinois Cancer Center - Peoria, Illinois 964.3 miles Carrie Geoffroy 309-243-3605 None
Illinois Cancer Center - Peoria, Illinois 964.3 miles Carrie Geoffroy 309-243-3605 None
Illinois Cancer Center - Peoria, Illinois 964.3 miles Carrie Geoffroy 309-243-3605 None
Washington University - Saint Louis, Missouri 1,039.5 miles Katrina Pedersen MD 314-362-9115 kpedersen@wustl.edu
Saint Louis University Hospital - Saint Louis, Missouri 1,039.5 miles Debra King 314-577-8854 kingdl@slu.edu
Washington University - Saint Louis, Missouri 1,039.5 miles Katrina Pedersen MD 314-362-9115 kpedersen@wustl.edu
Saint Louis University Hospital - Saint Louis, Missouri 1,039.5 miles Debra King 314-577-8854 kingdl@slu.edu
Saint Louis University Hospital - Saint Louis, Missouri 1,039.5 miles Debra King 314-577-8854 kingdl@slu.edu
Washington University - Saint Louis, Missouri 1,039.5 miles Katrina Pedersen MD 314-362-9115 kpedersen@wustl.edu
Saint Louis University Hospital - Saint Louis, Missouri 1,039.5 miles Debra King 314-577-8854 kingdl@slu.edu
Washington University - Saint Louis, Missouri 1,039.5 miles Katrina Pedersen MD 314-362-9115 kpedersen@wustl.edu
University of Iowa Health Care University of Iowa Hospital - Iowa City, Iowa 1,050.4 miles Michelle Arnold RN 319-356-2778 None
University of Iowa Health Care University of Iowa Hospital - Iowa City, Iowa 1,050.4 miles Michelle Arnold RN 319-356-2778 None
University of Iowa Health Care University of Iowa Hospital - Iowa City, Iowa 1,050.4 miles Michelle Arnold RN 319-356-2778 None
University of Iowa Health Care University of Iowa Hospital - Iowa City, Iowa 1,050.4 miles Michelle Arnold RN 319-356-2778 None
Broward General Medical Center - Fort Lauderdale, Florida 1,237.6 miles Donna Stefinsky 954-712-3949 None
Broward General Medical Center - Fort Lauderdale, Florida 1,237.6 miles Donna Stefinsky 954-712-3949 None
Broward General Medical Center - Fort Lauderdale, Florida 1,237.6 miles Donna Stefinsky 954-712-3949 None
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Kayla Thompson 913-588-1886 kthompson8@kumc.edu
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Kayla Thompson 913-588-1886 kthompson8@kumc.edu
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Kayla Thompson 913-588-1886 kthompson8@kumc.edu
University of Kansas Cancer Center - Westwood, Kansas 1,252.9 miles Kayla Thompson 913-588-1886 kthompson8@kumc.edu
Sylvester Comprehensive Cancer Center - Miami, Florida 1,259.8 miles Eduardo Cianferra 305-243-1139 None
Sylvester Comprehensive Cancer Center - Miami, Florida 1,259.8 miles Eduardo Cianferra 305-243-1139 None
Sylvester Comprehensive Cancer Center - Miami, Florida 1,259.8 miles Eduardo Cianferra 305-243-1139 None
MD Anderson - Houston, Texas 1,609.9 miles Mary Brimer 713-792-2828 None
MD Anderson - Houston, Texas 1,609.9 miles Mary Brimer 713-792-2828 None
MD Anderson - Houston, Texas 1,609.9 miles Mary Brimer 713-792-2828 None
MD Anderson - Houston, Texas 1,609.9 miles Mary Brimer 713-792-2828 None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles Amy Szilard 720-848-0702 None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles Amy Szilard 720-848-0702 None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles Amy Szilard 720-848-0702 None
University of Colorado Hospital Anschutz Cancer Pavilion - Aurora, Colorado 1,759.8 miles Amy Szilard 720-848-0702 None
New Mexico Cancer Care - Albuquerque, New Mexico 1,968.8 miles Kim Steinberg RN 505-272-4946 KimSteinberg@salud.unm.edu
New Mexico Cancer Care - Albuquerque, New Mexico 1,968.8 miles Kim Steinberg RN 505-272-4946 KimSteinberg@salud.unm.edu
New Mexico Cancer Care - Albuquerque, New Mexico 1,968.8 miles Kim Steinberg RN 505-272-4946 KimSteinberg@salud.unm.edu
New Mexico Cancer Care - Albuquerque, New Mexico 1,968.8 miles Kim Steinberg RN 505-272-4946 KimSteinberg@salud.unm.edu
Medical Oncology Associates PS - Spokane, Washington 2,263.5 miles None None None
Medical Oncology Associates PS - Spokane, Washington 2,263.5 miles None None None
Medical Oncology Associates PS - Spokane, Washington 2,263.5 miles None None None
Medical Oncology Associates PS - Spokane, Washington 2,263.5 miles None None None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Ibrahim Abukenda 206-341-8993 None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Ibrahim Abukenda 206-341-8993 None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Ibrahim Abukenda 206-341-8993 None
Virginia Mason Medical Center - Seattle, Washington 2,489.8 miles Ibrahim Abukenda 206-341-8993 None
Oregon Health and Science University Knight Cancer Institute - Portland, Oregon 2,538.3 miles Knight Clinical Trials Information Line 503-494-1080 None
Oregon Health and Science University Knight Cancer Institute - Portland, Oregon 2,538.3 miles Knight Clinical Trials Information Line 503-494-1080 None
Oregon Health and Science University Knight Cancer Institute - Portland, Oregon 2,538.3 miles Knight Clinical Trials Information Line 503-494-1080 None
Oregon Health and Science University Knight Cancer Institute - Portland, Oregon 2,538.3 miles Knight Clinical Trials Information Line 503-494-1080 None
Compassionate Cancer Care Medical Group - Riverside, California 2,552.4 miles Corina King 951-276-2760 None
Compassionate Cancer Care Medical Group - Riverside, California 2,552.4 miles Corina King 951-276-2760 None
Compassionate Cancer Care Medical Group Inc Corona - Corona, California 2,564.5 miles None None None
Compassionate Cancer Care Medical Group Inc Corona - Corona, California 2,564.5 miles None None None
Compassionate Cancer Care Medical Group Inc Corona - Corona, California 2,564.5 miles None None None
Compassionate Cancer Care Medical Group Inc Corona - Corona, California 2,564.5 miles None None None
City of Hope Comprehensive Cancer Center - Duarte, California 2,578.2 miles None None None
City of Hope Comprehensive Cancer Center - Duarte, California 2,578.2 miles None None None
City of Hope Comprehensive Cancer Center - Duarte, California 2,578.2 miles None None None
City of Hope Comprehensive Cancer Center - Duarte, California 2,578.2 miles None None None
Compassionate Care Research Group Inc - Fountain Valley, California 2,590.7 miles Barbara Lepthien 714-698-0300 None
Compassionate Care Research Group Inc - Fountain Valley, California 2,590.7 miles Barbara Lepthien 714-698-0300 None
Compassionate Care Research Group Inc - Fountain Valley, California 2,590.7 miles Barbara Lepthien 714-698-0300 None
Compassionate Care Research Group Inc - Fountain Valley, California 2,590.7 miles Barbara Lepthien 714-698-0300 None
University of Southern California USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles Marile Garcia Leiva 323-865-3000 Marile.GarciaLeiva@med.usc.edu
University of Southern California USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles Marile Garcia Leiva 323-865-3000 Marile.GarciaLeiva@med.usc.edu
University of Southern California USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles Marile Garcia Leiva 323-865-3000 Marile.GarciaLeiva@med.usc.edu
University of Southern California USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles Marile Garcia Leiva 323-865-3000 Marile.GarciaLeiva@med.usc.edu

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