The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
PF-07799544/ARRY-134 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Canada
for more information at clinicaltrials.gov
EXPERIMENTAL: Monotherapy Dose Escalation (Phase 1a)
Participants will receive PF-07799544
DRUG: PF-07799544
TabletDRUG: encorafenib
CapsuleEXPERIMENTAL: Phase 1b Substudy B Combination Dose Escalation
Participants will receive PF-07799544 and PF-07799933
DRUG: PF-07799544
TabletDRUG: PF-07799933
TabletEXPERIMENTAL: Phase 1b Substudy B Combination Dose Expansion
Participants will receive PF-07799544 and PF-07799933
DRUG: PF-07799544
TabletDRUG: PF-07799933
TabletEXPERIMENTAL: Phase 1b Substudy C Combination Dose Expansion
Participants will receive PF-07799544 and PF-07799933
DRUG: PF-07799544
TabletDRUG: PF-07799933
TabletNumber of participants with dose limiting toxicities (DLTs) Phase 1a monotherapy and Phase 1b combination therapy dose escalation
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)
Cycle 1 (21 days)
Overall response rate (ORR) (phase 1b expansion)
Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Baseline to 2 years
Number of participants with treatment-emergent adverse events (AEs) (phase 1a and 1b dose escalation phases)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline to 28 days after last dose of study medication
Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase)
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase)
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 28 days after last dose of study treatment
Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase)
Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Baseline to 28 days after last dose of study treatment
Number of participants with treatment-emergent adverse events (AEs)
AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy
Baseline to 2 years
Number of participants with clinically significant change from baseline in laboratory abnormalities
Laboratory abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 2 years
Number of participants with clinically significant change from baseline in vital sign abnormalities
Vital sign abnormalities as characterized by type, frequency, severity, and timing.
Baseline to 2 years
PK parameters of PF-07799544, Single dose, maximum observed concentration (Cmax)
PK parameters of PF-07799544, Single dose, Cmax
Baseline to 2 years
PK parameters of PF-07799544, Single dose, time to maximum plasma concentration (Tmax)
PK parameters of PF-07799544, Single dose, Tmax
Baseline to 2 years
PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
PK parameters of PF-07799544, Single dose, AUClast
Baseline to 2 years
PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
PK parameters of PF-07799544, Single dose, AUCinf
Baseline to 2 years
PK parameters of PF-07799544, Single dose, terminal elimination half life (t½)
PK parameters of PF-07799544, Single dose, t½
Baseline to 2 years
PK parameters of PF-07799544, Single dose, apparent oral clearance (CL/F)
PK parameters of PF-07799544, Single dose, CL/F
Baseline to 2 years
PK parameters of PF-07799544, Single dose, apparent volume of distribution (Vz/F)
PK parameters of PF-07799544, Single dose, Vz/F
Baseline to 2 years
PK parameters of PF-07799544, Multiple dose, maximum observed concentration (Cmax)
PK parameters of PF-07799544, Multiple dose, Cmax
Baseline to 2 years
PK parameters of PF-07799544, Multiple dose, time to maximum plasma concentration (Tmax)
PK parameters of PF-07799544, Multiple dose, Tmax
Baseline to 2 years
PK parameters of PF-07799544, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ)
PK parameters of PF-07799544, Multiple dose, AUCτ
Baseline to 2 years
PK parameters of PF-07799544, Multiple dose, terminal elimination half life (t½)
PK parameters of PF-07799544, Multiple dose, t½
Baseline to 2 years
PK parameters of PF-07799544, Multiple dose, apparent oral clearance (CL/F)
PK parameters of PF-07799544, Multiple dose, CL/F
Baseline to 2 years
PK parameters of PF-07799544, Multiple dose, apparent volume of distribution (Vz/F)
PK parameters of PF-07799544, Multiple dose, Vz/F
Baseline to 2 years
PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax)
PK parameters of PF-07799933, Single dose, Cmax
Baseline to 2 years
PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax)
PK parameters of PF-07799933, Single dose, Tmax
Baseline to 2 years
PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast)
PK parameters of PF-07799933, Single dose, AUClast
Baseline to 2 years
PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf)
PK parameters of PF-07799933, Single dose, AUCinf
Baseline to 2 years
PK parameters of PF-07799933, Single dose, terminal elimination half life (t½)
PK parameters of PF-07799933, Single dose, t½
Baseline to 2 years
PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F)
PK parameters of PF-07799933, Single dose, CL/F
Baseline to 2 years
PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F)
PK parameters of PF-07799933, Single dose, Vz/F
Baseline to 2 years
PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax)
PK parameters of PF-07799933, Multiple dose, Cmax
Baseline to 2 years
PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax)
PK parameters of PF-07799933, Multiple dose, Tmax
Baseline to 2 years
PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCτ)
PK parameters of PF-07799933, Multiple dose, AUCτ
Baseline to 2 years
PK parameters of PF-07799933, Multiple dose, terminal elimination half life (t½)
PK parameters of PF-07799933, Multiple dose, t½
Baseline to 2 years
PK parameters of PF-07799933, Multiple dose, apparent oral clearance (CL/F)
PK parameters of PF-07799933, Multiple dose, CL/F
Baseline to 2 years
PK parameters of PF-07799933, Multiple dose, apparent volume of distribution (Vz/F)
PK parameters of PF-07799933, Multiple dose, Vz/F
Baseline to 2 years
ORR (phase 1a and phase 1b dose escalation)
ORR as assessed using the RECIST version 1.1.
Baseline to 2 years
Duration of response overall and in CNS
Baseline to 2 years
Intracranial response (phase 1b Part 2)
Intracranial response by RECIST version 1.1 (for brain metastases)
Baseline to 2 years
PFS
Baseline to 2 years
124
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT05538130
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