NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A FIH Study of PF-07284890 in Participants With BRAF V600 Mutant Solid Tumors With and Without Brain Involvement

TerminatedPhase 1

Sponsor: Pfizer

Conditions: Malignant Melanoma, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Primary, Brain Neoplasms, Malignant Neoplasms

Interventions: PF-07284890, Binimetinib, Midazolam

Countries: United States, Canada, Israel

First-in-human study to assess safety, tolerability, PK, and preliminary activity of PF-07284890 as a single agent and in combination with binimetinib in participants with BRAF V600-mutated advanced solid tumor malignancies with and without brain involvement.

Eligibility overview

Sex: ALL

Age: 16 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (45)

Duarte, California, United States
San Francisco, California, United States
Orlando, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Iowa City, Iowa, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Brookline, Massachusetts, United States
Chestnut Hill, Massachusetts, United States
Foxborough, Massachusetts, United States
Newton, Massachusetts, United States
City of Saint Peters, Missouri, United States
Creve Coeur, Missouri, United States
Florissant, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Hackensack, New Jersey, United States
Hackensack, New Jersey, United States
Middletown, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
+ 15 more on CT.gov