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Trial record 1 of 8 for:    beacon | Colorectal Cancer
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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 : Completed
First Posted : October 10, 2016
Results First Posted : July 14, 2020
Last Update Posted : May 6, 2023
Sponsor:
Collaborators:
Merck KGaA, Darmstadt, Germany
Pierre Fabre Medicament
Ono Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Pfizer

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 702 participants
Allocation: Randomized
Intervention Model: Sequential 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 13, 2016
Actual Primary Completion Date : February 11, 2019
Actual Study Completion Date : November 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Safety

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. (Safety Lead-in) Number of Participants With Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 1 (up to 28 days) ]
  2. (Safety Lead-in) Number of Participants With Adverse Events (AEs) [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
    Refer to AE/SAE section for additional data that were measured and analyzed.

  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) by Investigator [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  2. (Safety Lead-in) Response Rate (ORR) by BICR [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
    ORR per RECIST, v1.1, defined as the number of patients achieving an overall best response of CR or partial response (PR) divided by the total number of patients

  3. (Safety Lead-in) Duration of Response (DOR) by Investigator [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  4. (Safety Lead-in) Duration of Response (DOR) by BICR [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
    DOR defined as the time from first radiographic evidence of response to the earliest documented disease progression or death due to underlying disease

  5. (Safety Lead-in) Time to Response by Investigator [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
    Time to response defined as the time from first dose to first radiographic evidence of response

  6. (Safety Lead-in) Time to Response by BICR [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
    Time to response defined as the time from first dose to first radiographic evidence of response

  7. (Safety Lead-in) Progression-free Survival (PFS) by Investigator [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
  8. (Safety Lead-in) Progression-free Survival (PFS) by BICR [ Time Frame: Duration of safety lead-in, approximately 6 months (up to 28 days per cycle) ]
    PFS defined as the time from first dose to the earliest documented disease progression or death due to any cause

  9. (Phase 3) Overall Survival (OS) in Doublet Arm vs. Control Arm [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  10. (Phase 3) Overall Survival (OS) in Triplet Arm vs. Doublet Arm [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  11. (Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Control Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  12. (Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  13. (Phase 3) Comparison of Progression-free Survival (PFS) in Doublet Arm vs Control Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  14. (Phase 3) Comparison of Progression-free Survival (PFS) in Doublet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  15. (Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Doublet Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  16. (Phase 3) Comparison of Progression-free Survival (PFS) in Triplet Arm vs Doublet Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  17. Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  18. (Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  19. (Phase 3) Comparison of Objective Response Rate (ORR) in Doublet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  20. Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  21. Phase 3) Comparison of Objective Response Rate (ORR) in Triplet Arm vs Doublet Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  22. (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  23. (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  24. (Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  25. (Phase 3) Comparison of Duration of Response (DOR) in Doublet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  26. (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  27. (Phase 3) Comparison of Duration of Response (DOR) in Triplet Arm vs Doublet Arm by Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  28. (Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  29. (Phase 3) Comparison of Time to Response in Triplet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  30. (Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  31. (Phase 3) Comparison of Time to Response in Doublet Arm vs Control Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  32. (Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per BICR [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  33. (Phase 3) Comparison of Time to Response in Triplet Arm vs Doublet Arm Per Investigator [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
  34. (Phase 3) Change From Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Cancer Patients (QLQ-C30) Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
    The EORTC QLQ-C30 questionnaire consisted of 30 questions generating five functional scores (physical, role, cognitive, emotional, and social); a global health status/global quality of life scale score; three symptom scale scores (fatigue, pain, and nausea and vomiting); and six stand alone one-item scores that capture additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and perceived financial burden. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning.

  35. (Phase 3) Change From Baseline in the Functional Assessment of Cancer Therapy-Colon Cancer (FACT-C) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
    FACT-C is a well-characterized and commonly used questionnaire that belongs to the Functional Assessment of Chronic Illness Therapy Measurement System (FACIT). The FACT-G (G for general) questionnaire (27 questions) constitutes the core of all subscales and is applicable to all tumor types. The FACT-C questionnaire contains 9 additional questions on symptoms specific to CRC, 2 of which are only answered by patients with ostomy appliances. These 9 CRC-specific questions are categorized as "additional concerns" on the questionnaire and constitute the "colorectal cancer subscale" score. The patient self-reports his/her QoL for the previous 7 days. The overall score is calculated across all items and a higher score reflects better quality of life (QoL). The table summarizes the functional well-being subscale, the individual questions are linearly scaled and combined to form the functional well-being subscale score, which ranges from 0-28 (higher is better QoL).

  36. (Phase 3) Change From Baseline in the EuroQol-5D-5L (EQ-5D-5L) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
    The EQ-5D-5L contains 1 item for each of 5 dimensions of health-related QoL (i.e., mobility, self-care, usual activities, pain or discomfort and anxiety or depression). Response options for each item varied from having no problems to moderate problems or extreme problems. The EQ-5D-5L (v4.0) is a standardized measure of health utility that provides a single index value for one's health status. The EQ-5D-5L is frequently used for economic evaluations of health care and has been recognized as a valid and reliable instrument for this purpose. The EQ visual analog scale (VAS) is a score that is directly reported by the patient and ranges from 0 to 100 (higher is better quality health).

  37. (Phase 3) Change From Baseline in the Patient Global Impression of Change (PGIC) in Triplet Arm vs Control Arm, Doublet Arm vs Control, and Triplet vs Doublet [ Time Frame: Duration of Phase 3, approximately 6 months (up to 28 days per cycle) ]
    The PGIC is a measure of patients' perceptions of change in their symptoms over time that can be used as an anchoring method to determine the minimal clinically important difference for other patient reported outcome (PROs). For this assessment, patients answered the following question: "Since starting treatment, my colorectal cancer symptoms are: (1) very much improved, (2) much improved, (3) minimally improved, (4) no change, (5) minimally worse, (6) much worse or (7) very much worse."

  38. (Safety Lead-in) Evaluation of the Area Under the Concentration-time Curve (AUC) for Cetuximab [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  39. (Safety Lead-in) Evaluation of the Area Under the Concentration-time Curve (AUC) for Encorafenib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  40. (Safety Lead-in) Evaluation of the Area Under the Concentration-time Curve (AUC) for Binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  41. (Safety Lead-in) Evaluation of the Area Under the Concentration-time Curve (AUC) for Metabolite of Binimetinib (AR00426032) [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  42. (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Cetuximab [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  43. (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Encorafenib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  44. (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  45. (Safety Lead-in) Evaluation of the Maximum Concentration (Cmax) for Metabolite of Binimetinib (AR00426032) [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  46. (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Cetuximab [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  47. (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Encorafenib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  48. (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  49. (Safety Lead-in) Evaluation of the Time of Maximum Observed Concentration (Tmax) for Metabolite of Binimetinib (AR00426032) [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  50. (Safety Lead-in) Evaluation of the Steady-state Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  51. (Safety Lead-in) Evaluation of the Steady-state Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Encorafenib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  52. (Safety Lead-in) Evaluation of the Steady-state Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for Cetuximab [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  53. (Safety Lead-in) Evaluation of the Steady-state Concentration Measured Just Before the Next Dose of Study Drug (Ctrough) for a Metabolite of Binimetinib [ Time Frame: Predose and 1, 2, 4 and 6 hours post-dose on Day 1 of Cycles 1 and 2 ]
  54. (Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Encorafenib [ Time Frame: 2 and 6 hours post-dose on Day 1 of Cycle 1. Predose and 2 hours post-dose on Day 1 of Cycle 2. ]
    The cross-arm CL/F value is based on the theta determined from a population PK analysis. Data for this Outcome Measure are not reported here because as per plan, the analysis includes pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID for those studies for which results have not yet been posted include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register.

  55. (Phase 3) Evaluation of the Model-Based Oral Clearance (CL/F) for Binimetinib [ Time Frame: 2 and 6 hours post-dose on Day 1 of Cycle 1. Predose and 2 hours post-dose on Day 1 of Cycle 2. ]
    The cross-arm CL/F value is based on the theta determined from a population PK analysis. Data for this Outcome Measure are not reported here because as per plan, the analysis includes pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID for those studies for which results have not yet been posted include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register.

  56. (Phase 3) Evaluation of the Model-Based Clearance (CL) for Cetuximab [ Time Frame: 2 and 6 hours post-dose on Day 1 of Cycle 1. Predose and 2 hours post-dose on Day 1 of Cycle 2. ]
    The cross-arm CL/F value is based on the theta determined from a population PK analysis. Data for this Outcome Measure are not reported here because as per plan, the analysis includes pooled data from participants enrolled in multiple studies including those who were not enrolled in this study. The NCTID for those studies for which results have not yet been posted include: NCT01719380, NCT01543698, and NCT01436656. An additional study ARRAY-162-105 is not required to register.


Eligibility Criteria
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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.


Layout table for eligibility information
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 epidermal growth factor receptor (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 creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
  • Residual common terminology criteria for adverse events (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
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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


Locations
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Sponsors and Collaborators
Pfizer
Merck KGaA, Darmstadt, Germany
Pierre Fabre Medicament
Ono Pharmaceutical Co. Ltd
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
  Study Documents (Full-Text)

Documents provided by Pfizer:
Study Protocol  [PDF] January 11, 2019
Statistical Analysis Plan  [PDF] January 28, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02928224    
Other Study ID Numbers: ARRAY-818-302
BEACON CRC ( Other Identifier: Alias Study Number )
2015-005805-35 ( EudraCT Number )
C4221009 ( Other Identifier: Pfizer )
First Posted: October 10, 2016    Key Record Dates
Results First Posted: July 14, 2020
Last Update Posted: May 6, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Pfizer:
Colorectal cancer
BRAF
BRAFV600E
Additional relevant MeSH terms:
Layout table for 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
Leucovorin
Folic Acid
Fluorouracil
Irinotecan
 Cetuximab
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antineoplastic Agents, Immunological
Antidotes
Protective Agents