A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement
NCT ID: NCT04543188
Last Updated: 2025-10-23
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
65 participants
INTERVENTIONAL
2021-01-08
2024-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PF-07284890 (Part A monotherapy)
Monotherapy dose escalation of PF-07284890
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
PF-07284890+binimetinib (Part A combo-therapy)
Combination dose escalation of PF-07284890 + binimetinib
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Expansion Phase (Part B, Cohort 1)
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with asymptomatic brain involvement, and no prior BRAF or MEK inhibitor utilization
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Expansion Phase (Part B, Cohort 2)
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with symptomatic brain involvement, and no prior BRAF or MEK inhibitor utilization
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Expansion Phase (Part B, Cohort 3)
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with asymptomatic brain involvement, and prior BRAF inhibitor utilization
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Expansion Phase (Part B, Cohort 4)
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 melanoma, with symptomatic brain involvement, and prior BRAF inhibitor utilization
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Expansion Phase (Part B Cohort 5)
PF-07284890 (at recommended dose from Part A) plus binimetinib in participants with BRAF V600 solid tumor; history of or current leptomeningeal metastases; without disease in the brain; with disease in the brain that does not meet Cohorts 1-4; asymptomatic or symptomatic in the brain; primary brain tumors
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Expansion Phase Drug-Drug Interaction Substudy (Part B Optional Cohort 6)
PF-07284890 (at recommended dose from Part A) plus binimetinib plus midazolam in participants with BRAF V600 solid tumor
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Midazolam
Midazolam will be administered 7 days before start of study drug, on Cycle 1 Day 1, and on Cycle 1 Day 15
Expansion Phase (Part B Optional Cohort 7)
PF-07284890 (at the recommended dose for expansion when administered with food) plus binimetinib in participants with BRAF V600 solid tumor
PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Interventions
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PF-07284890
PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
Binimetinib
Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
Midazolam
Midazolam will be administered 7 days before start of study drug, on Cycle 1 Day 1, and on Cycle 1 Day 15
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed diagnosis of advanced/metastatic solid tumor including primary brain tumor
* Documented evidence of a BRAF V600 mutation in tumor tissue or blood
* Confirmation of availability of adequate tumor tissue for submission to the sponsor/central laboratory
* Presence or absence of brain involvement unless specified below
* Dose Expansion (Part B)
* Cohort 1, 2, 3, 4: melanoma with at least 1 parenchymal brain lesion
* Cohort 1,3: asymptomatic in the brain for at least 14 days prior to start of study treatment
* Cohort 2,4: symptomatic in the brain within 14 days prior to the start of study treatment
* Cohort 5: any solid tumor that does not meet requirements for Cohorts 1-4, history of or current leptomeningeal metastases.
* Optional Cohort 6 (DDI Sub-study) and 7 (Food-Effect): if brain involvement present, must be asymptomatic
* Disease progression despite prior treatment and no acceptable alternative treatment options available unless specified below
* Dose Expansion (Part B)
* Cohort 1, 2: No prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of study treatment
* Cohort 3, 4: Required prior BRAF inhibitor in the metastatic setting or in the adjuvant setting within 6 months of treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria
* History of or current leptomeningeal metastases
* Any other active malignancy within 2 years prior to enrollment
* Radiation therapy to visceral metastases within 14 days prior to study treatment. WBRT within 28 days prior to study treatment.
* Systemic anti-cancer therapy or small-molecular therapeutic(s) within 2 weeks prior to start of study treatment; Antibody based agents within 4 weeks prior to start of study treatment.
* History or current evidence of RVO or current risk factors for RVO; History of retinal degenerative disease
16 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
Orlando Health Cancer Institute
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Richard M Schulze Family Foundation Outpatient Center at McKinley Campus
Tampa, Florida, United States
Northwestern Medical Group
Chicago, Illinois, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Johns Hopkins University / Johns Hopkins Hospital
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Imaging: Brigham and Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Imaging: Brigham and Women's Radiology, Coolidge Corner Imaging
Brookline, Massachusetts, United States
Imaging: Brigham and Women's Ambulatory Care
Chestnut Hill, Massachusetts, United States
Imaging: Brigham and Women's Mass General Healthcare Center
Foxborough, Massachusetts, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
MSK Monmouth.
Middletown, New Jersey, United States
MSK Commack
Commack, New York, United States
MSKCC-Westchester (500 Westchester Ave.)
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States
Rockefeller Outpatient Pavilion (53rd Street)
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke Eye Center
Durham, North Carolina, United States
Duke University Medical Center, Investigational Chemotherapy Services
Durham, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Tennessee Oncology PLLC
Franklin, Tennessee, United States
Tennessee Oncology PLLC
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Rambam Health Care Campus
Haifa, ?eif?, Israel
Rabin Medical Center
Petah Tikva, Central District, Israel
Sheba Medical Center
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, Israel
Countries
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References
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Ren L, Moreno D, Baer BR, Barbour P, Bettendorf T, Bouhana K, Brown K, Brown SA, Fell JB, Hartley DP, Hicken EJ, Laird ER, Lee P, McCown J, Otten JN, Prigaro B, Wallace R, Kahn D. Identification of the Clinical Candidate PF-07284890 (ARRY-461), a Highly Potent and Brain Penetrant BRAF Inhibitor for the Treatment of Cancer. J Med Chem. 2024 Aug 8;67(15):13019-13032. doi: 10.1021/acs.jmedchem.4c00998. Epub 2024 Jul 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2022-003184-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4471001
Identifier Type: -
Identifier Source: org_study_id
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