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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-07104091 is an investigational compound. Its safety and efficacy have not been established.
Active enrolling
United States, China, Japan, Mexico
EXPERIMENTAL: PF-07104091
CDK2 monotherapy dose escalation
DRUG: PF-07104091 monotherapy dose escalation
PF-07104091 will be administered orally
EXPERIMENTAL: PF-07104091 + palbociclib + fulvestrant
CDK2 + palbociclib + fulvestrant
DRUG: PF-07104091 + palbociclib + fulvestrant
PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
EXPERIMENTAL: PF-07104091 + palbociclib + letrozole
CDK2 + palbociclib + letrozole
DRUG: PF-07104091 + palbociclib + letrozole
PF-07104091 will be administered orally in combination with palbociclib and letrozole
EXPERIMENTAL: PF-07104091 monotherapy dose expansion (SCLC)
PF-07104091 monotherapy dose expansion (SCLC)
DRUG: PF-07104091 monotherapy dose expansion (SCLC)
PF-07104091 will be administered orally
EXPERIMENTAL: PF-07104091 monotherapy dose expansion (ovarian)
PF-07104091 monotherapy dose expansion (ovarian)
DRUG: PF-07104091 monotherapy dose expansion (ovarian)
PF-07104091 will be administered orally
EXPERIMENTAL: PF-07104091 + fulvestrant (post CDK4/6) dose expansion
PF-07104091 + fulvestrant (post CDK4/6) dose expansion
DRUG: PF-0704091 + Fulvestrant (post CDK4/6)
PF-07104091 + fulvestrant (post 4/6) dose expansion
EXPERIMENTAL: PF-07104091 + fulvestrant (post CDK 4/6) dose escalation
CDK2+ fulvestrant (post CDK 4/6) dose escalation
DRUG: PF-07104091 + Fulvestrant (post CDK4/6)
PF-07104091 will be administered orally in combination with fulvestrant
Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle
Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level
28 days
To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level
From baseline until end of study treatment or study completion (approximately 2 years)
Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline
Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level
From baseline until end of study treatment or study completion (approximately 2 years)
Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline
Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level
From baseline until end of study treatment or study completion (approximately 2 years)
To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline
Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level
From baseline until end of study treatment or study completion (approximately 2 years)
To evaluate the preliminary antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose expansion
Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1
From baseline through disease progression or study completion (approximately 2 years)
Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose
Peak concentration of PF-07104091 during selected cycles
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose
Time to peak concentration of PF-07104091 during selected cycles
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091
AUC of PF-07104091 will be calculated at selected cycles
Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Area under the curve of PF-07104091 with or without food
AUC of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
From baseline through time to event on study or study completion (approximately 2 years)
Maximum plasma concentration of PF-07104091 with or without food
Peak concentrations of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food
From baseline through time to event on study or study completion (approximately 2 years)
To document any preliminary evidence of antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose escalation
Percentage of participants with a best overall response of CR or PR using RECIST 1.1
From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)
To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints
Time from first assessment of event endpoint to last assessment of using RECIST 1.1
From baseline through time to event on study or study completion (approximately 2 years)
320
Sponsor: Pfizer
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: