Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
16–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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 may not be 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
