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Early trial of experimental cancer drug halted; data still under review

NCT ID NCT04543188

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested a new drug called PF-07284890, alone or with another drug (binimetinib), in 65 people with advanced cancers that have a specific genetic change (BRAF V600 mutation), including cancers that spread to the brain. The trial was terminated early, but researchers collected information on safety, dosing, and how the drug moves through the body. The goal was to find a safe dose and see if the drug shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PF-07284890 (also called ARRY-461), given alone or with binimetinib
What this could lead to
If successful, this could point toward a new treatment option for people with BRAF V600-mutated cancers, including those that have spread to the brain.
What could go wrong
This was a very early (Phase 1) study that was terminated, so results are limited. The drug may not prove effective or safe in larger trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

65 people

The number who actually took part.

Started

Jan 2021

Finished

Mar 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

16 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥16 years at the time of consent * 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: * Brain metastasis/primary brain tumor requiring immediate local intervention * 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

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Conditions

The condition(s) this trial relates to.

brain cancer brain disorder brain neoplasm cancer central nervous system cancer melanoma neoplasm non-small cell lung carcinoma primary brain neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain neoplasms Brain neoplasms, primary Carcinoma, non-small-cell lung Malignant melanoma Malignant neoplasms

Contacts and locations

Locations

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Brigham & Women's Hospital

    Boston, Massachusetts, 02115, United States

  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

    Duarte, California, 91010, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute - Chestnut Hill

    Newton, Massachusetts, 02459, United States

  • Duke Eye Center

    Durham, North Carolina, 27705, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Duke University Medical Center, Investigational Chemotherapy Services

    Durham, North Carolina, 27710, United States

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001, Israel

  • Imaging: Brigham and Women's Ambulatory Care

    Chestnut Hill, Massachusetts, 02467, United States

  • Imaging: Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Imaging: Brigham and Women's Mass General Healthcare Center

    Foxborough, Massachusetts, 02035, United States

  • Imaging: Brigham and Women's Radiology, Coolidge Corner Imaging

    Brookline, Massachusetts, 02446, United States

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Johns Hopkins University / Johns Hopkins Hospital

    Baltimore, Maryland, 21231, United States

  • MSK Commack

    Commack, New York, 11725, United States

  • MSK Monmouth.

    Middletown, New Jersey, 07748, United States

  • MSKCC-Westchester (500 Westchester Ave.)

    Harrison, New York, 10604, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

    New York, New York, 10021, United States

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Northwestern Medical Group

    Chicago, Illinois, 60611, United States

  • Northwestern Memorial Hospital

    Chicago, Illinois, 60611, United States

  • Ophthalmic Consultants of Boston Inc (OCB)

    Boston, Massachusetts, 02114, United States

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center

    Petah Tikva, Central District, 49100, Israel

  • Rambam Health Care Campus

    Haifa, ?eif?, 3109601, Israel

  • Richard M Schulze Family Foundation Outpatient Center at McKinley Campus

    Tampa, Florida, 33612, United States

  • Rockefeller Outpatient Pavilion (53rd Street)

    New York, New York, 10022, United States

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100, Israel

  • Siteman Cancer Center - North County

    Florissant, Missouri, 63031, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    Creve Coeur, Missouri, 63141, United States

  • Sourasky Medical Center

    Tel Aviv, TELL ABĪB, 6423906, Israel

  • Tennessee Oncology PLLC

    Franklin, Tennessee, 37067, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94143, United States

  • UNC Hospitals, The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

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