BRAF mutation positive solid tumors
Conditions
Interventions
*Drug: PF-07799544
-Tablet
-Other Names:
#ARRY-134
*Drug: PF-07799933
-Tablet
-Other Names:
#ARRY-440
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase 1b Inclusion Criteria: *Diagnosis of advanced/metastatic solid tumor (excluding colorectal cancer) *Measurable disease by RECIST version 1.1 *Evidence of a BRAF V600 mutation *Prior therapy per tumor cohort *Adequate organ function per protocol
Exclusion criteria
Exclusion criteria: Phase 1b Exclusion Criteria: *Other active malignancy within 3 years *Presence of leptomeningeal disease *History or current evidence of retinal vein occlusion (RVO) or history of retinal degenerative disease *Concurrent neuromuscular disorder associated with elevated creatine kinase (CK) *Active gastrointestinal disease as defined per protocol *History of interstitial lung disease as defined per protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with dose limiting toxicities (DLTs) [Time Frame: Cycle 1 (21 days)] -DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation) *Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with treatment-emergent adverse events (AEs) [Time Frame: Baseline to 28 days after last dose of study medication] -AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy *Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in laboratory abnormalities [Time Frame: Baseline to 28 days after last dose of study treatment] -Laboratory abnormalities as characterized by type, frequency, severity, and timing. *Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in vital sign abnormalities [Time Frame: Baseline to 28 days after last dose of study treatment] -Vital sign abnormalities as characterized by type, frequency, severity, and timing. *Phase 1a monotherapy and Phase 1b combination dose escalation: Number of participants with clinically significant change from baseline in physical exam abnormalities [Time Frame: Baseline to 28 days after last dose of study treatment] -Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. *Phase 1b Dose Expansion: Overall response rate (ORR) [Time Frame: Baseline to 2 years] -Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors | — |
Secondary
| Measure | Time frame |
|---|---|
| *Phase 1a monotherapy and Phase 1b combination dose escalation: ORR [Time Frame: Baseline to 2 years] -ORR as assessed using the RECIST version 1.1. *Phase 1b Dose Expansion: Number of participants with treatment-emergent adverse events (AEs) [Time Frame: Baseline to 2 years] -AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy *Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in vital sign abnormalities [Time Frame: Baseline to 2 years] -Vital sign abnormalities as characterized by type, frequency, severity, and timing. *Phase 1b Dose Expansion: Number of participants with clinically significant change from baseline in laboratory abnormalities [Time Frame: Baseline to 2 years] -Laboratory abnormalities as characterized by type, frequency, severity, and timing. *Phase 1b Dose Expansion: Duration of Response (Overall and in CNS) [Time Frame: Baseline to 2 years] -Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors *Phase 1b Dose Expansion: Intracranial response [Time Frame: Baseline to 2 years] -Intracranial response by RECIST version 1.1 (for brain metastases) *Phase 1b Dose Expansion: Progression Free Survival (PFS) [Time Frame: Baseline to 2 years] -Response will be evaluated via radiographical tumor assessments by RECIST v1.1 for solid tumors or RANO for primary brain tumors *PK Parameters: Maximum Observed Concentration (Cmax) [Time Frame: Baseline to 2 years] -Single dose and multiple dose PK will be calculated as data permits *PK Parameters: Maximum Plasma Concentration (Tmax) [Time Frame: Baseline to 2 years] -Single dose and multiple dose PK will be calculated as data permits *PK Parameters: Area Under Curve (AUC) [Time Frame: Baseline to 2 years] -Single dose and multiple dose PK will be calculated as data permits *PK Parameters: terminal elimination half-life (t1/2) [Time Frame: B | — |
Countries
Australia, Brazil, Canada, China, Israel, Japan, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed