Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

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 Lung Neoplasms Lung Diseases Enzyme Inhibitors Neoplasms Midazolam Binimetinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥18 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 or NSCLC 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.
  • Cohort 6 (DDI Sub-study): 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 not yet accepting patients
    San Francisco California 94143 United States
  • UCSF Medical Center not yet accepting patients
    San Francisco California 94158 United States

Details

Status
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
Study Type
Interventional
Last Updated