Summary

Eligibility
for people ages 16 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Katy Tsai
Headshot of Katy Tsai
Katy Tsai

Description

Summary

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.

Official Title

A TWO-PART, PHASE 1A/B, OPEN-LABEL, MULTICENTER TRIAL EVALUATING PHARMACOKINETICS, SAFETY AND EFFICACY OF PF-07284890 (ARRY 461) IN PARTICIPANTS WITH BRAF V600 MUTANT SOLID TUMORS WITH AND WITHOUT BRAIN INVOLVEMENT

Keywords

Malignant Melanoma, Carcinoma, Non-Small-Cell Lung, Brain Neoplasms, Primary, Brain Neoplasms, Malignant Neoplasms, Proto-Oncogene Proteins B-raf, Melanoma, Brain Diseases, Central Nervous System Neoplasms, Enzyme Inhibitors, Neoplasms, Non-Small-Cell Lung Carcinoma, Midazolam, Binimetinib

Eligibility

You can join if…

Open to people ages 16 years and up

  • 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

You CAN'T join if...

  • 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

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco California 94143 United States
  • UCSF Medical Center
    San Francisco California 94158 United States

Lead Scientist at UCSF

  • Katy Tsai
    Dr. Katy K. Tsai is a medical oncologist and clinical researcher who specializes in treating advanced melanoma and other non-melanoma skin cancers, such as squamous cell carcinoma, basal cell carcinoma, and Merkel cell carcinoma. Dr. Tsai graduated with a degree in comparative literature from Brown University before earning her medical degree from Brown.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT04543188
Phase
Phase 1 research study
Study Type
Interventional
Participants
About 57 people participating
Last Updated