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-07248144 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, Japan, Puerto Rico
EXPERIMENTAL: Arm A: PF-07248144 plus fulvestrant
PF-07248144 tablet taken by mouth plus fulvestrant taken as a shot into the muscle.
DRUG: PF-07248144
KAT6 inhibitor
DRUG: Fulvestrant
Endocrine therapy
ACTIVE_COMPARATOR: Arm B: everolimus plus ET
Everolimus tablet taken by mouth plus investigator's choice of endocrine therapy of exemestane tablet taken by mouth or fulvestrant taken as a shot into the muscle.
DRUG: Fulvestrant
Endocrine therapy
DRUG: Everolimus
mTOR inhibitor
DRUG: Exemestane
Endocrine therapy
Progression Free Survival (PFS) as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)
Overall Survival (OS)
From the date of randomization until death due to any cause (up to approximately 5 years).
Number of Participants with Objective Response (OR) by BICR
From the date of randomization until disease progression or death due to any cause (up to approximately 2 years)
Duration of Response (DoR) as defined by BICR
From the date of the first objective (PR or CR) response (every 8 weeks during the first 48 weeks and then every 12 week) up to approximately 2 years.
Number of Participants With Clinical Benefit Response (CBR) by BICR
From randomization date (every 8 weeks during the first 48 weeks and then every 12 weeks) up to approximately 2 years.
Number or Patients with Adverse Events (AEs) by Type
From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by Incidence
From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by Seriousness
From screening until 28 days after the last dose, to approximately 5 years
Number or Patients with AEs by relationship to study interventions
From screening until 28 days after the last dose, to approximately 5 years
Number of Participants With Abnormal Electrocardiogram (ECG; Arm A and B)
From screening until 28 days after the last dose, to approximately 5 years
Number of Participants With Increase From Baseline in Corrected QT (QTc) Interval (Arm A only)
The study includes a QTc sub-study in approximately 40 participants in Arm A enrolled at selected sites which will evaluate the effect of PF-07248144 on QTc interval via collection of triplicate ECGs (central reading) time-matched with pharmacokinetic (PK) draws.
0h pre-dose on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1, and Cycle 3 Day 1; additional 4 hrs post dose on Cycle 1 Day 15 and Cycle 2 Day 1
Number of Participants With Laboratory Test Abnormalities
From screening until 28 days after the last dose, to approximately 5 years
Ctrough of PF-07248144
Ctrough was defined as pre-dose serum concentration during multiple dosing and observed directly from data.
Cycle 1 (Day 1), Cycle 1 (Day 15), Cycle 2 (Day 1), and Cycles 3, 5, and 7 (Day 1) only. Each Cycle is 28 days
400
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.
NCT07062965
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