For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
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.
Vepdegestrant is an investigational compound. Its safety and efficacy have not been established. * Vepdegestrant is being co-developed with Arvinas.
Active Not-enrolling
United States
for more information at clinicaltrials.gov
EXPERIMENTAL: ARV-471
Parts A and B: ARV-471 administered QD or BID for 28 day cycles.
DRUG: ARV-471
Parts A and B: ARV-471 administered QD or BID for 28 day cycles.EXPERIMENTAL: ARV-471 and palbociclib (IBRANCE®)
Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days.
DRUG: ARV-471 in combination with palbociclib (IBRANCE®)
Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 daysPart A: Incidence of Dose Limiting Toxicities of ARV-471
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
28 Days
Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-471
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
First study drug dose through a minimum of 30 calendar Days After Last study drug administration
Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-471
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
First study drug dose through a minimum of 30 calendar Days After Last study drug administration
Part B: Assessment of anti-tumor activity of ARV-471
Clinical benefit response rate based on the summation of CRs, PRs and stable disease of 24 weeks duration or longer
through study completion, up to approximately 2 years
Part C: Incidence of Dose Limiting Toxicities of combination ARV-471 + palbociclib
First cycle dose-limiting toxicities and determination of a maximum tolerated dose (MTD) if applicable among the doses evaluated
28 Days
Part C: Number of Patients with Adverse Events as a measure of safety and tolerability of combination ARV-471 + palbociclib
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug combination
First study drug dose through a minimum of 30 calendar Days After Last study drug administration
Part C: Incidence of laboratory abnormalities as a measure of safety and tolerability of combination ARV-471 + palbociclib
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing
First study drug dose through a minimum of 30 calendar Days After Last study drug administration
Part A: Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
Concentration-time curve (AUC) for single and multiple dose of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of ARV-471
Part A: Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Maximum concentration (Cmax) for single and multiple dose of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of ARV-471
Part A: Assessment of pharmacokinetic parameter minimum concentration (Cmin).
Minimum concentration (Cmin) for single and multiple dose of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of ARV-471
Part A: Assessment of pharmacokinetic parameter time to maximum concentration (Tmax).
Time to maximum concentration (Tmax) for single and multiple dose of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of ARV-471
Part A: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating overall response rate per RECIST 1.1.
through study completion, up to approximately 2 years
Part A: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating clinical benefit response (CBR) rate based on the summation of complete responses (CRs), partial responses (PRs) and stable disease of 24 weeks duration or longer.
through study completion, up to approximately 2 years
Part A: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating disease control rate (complete response, partial response, stable disease).
through study completion, up to approximately 2 years
Part A: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating progression free survival.
through study completion, up to approximately 2 years
Part A: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating duration of response.
through study completion, up to approximately 2 years
Part B: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating overall response rate per RECIST 1.1 in patients with measurable disease at baseline.
through study completion, up to approximately 2 years
Part B: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating duration of response.
through study completion, up to approximately 2 years
Part B: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating progression-free survival.
through study completion, up to approximately 2 years
Part B: Assessment of anti-tumor activity of ARV-471
Anti-tumor activity of ARV-471 will be assessed by evaluating overall survival.
through study completion, up to approximately 2 years
Part B: Evaluation of Plasma Concentrations of ARV-471
To characterize the pre-dose concentrations of ARV-471.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of investigational products]
Part B: Evaluation of Safety and Tolerability
Further evaluation of safety and tolerability of ARV-471 will be based on adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
First study drug dose through a minimum of 30 calendar Days After Last study drug administration
Part B: Evaluation of Safety and Tolerability
Further evaluation of safety and tolerability of ARV-471 will be based on Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
First study drug dose through a minimum of 30 calendar Days After Last study drug administration
Part C:Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC)
Concentration-time curve (AUC) for single and multiple doses of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses, and of palbociclib when given alone and in combination with ARV-471.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of investigational products
Part C: Assessment of pharmacokinetic parameter maximum concentration (Cmax).
Maximum concentration (Cmax) for single and multiple doses of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses, and of palbociclib when given alone and in combination with ARV-471
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of investigational products
Part C: Assessment of pharmacokinetic parameter minimum concentration (Cmin).
Minimum concentration (Cmin) for single and multiple dose of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of investigational products
Part C: Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
Time to maximum concentration (Tmax) for single and multiple dose of ARV-471 PK parameters will be assessed when applicable after a single dose and after multiple doses.
At predefined intervals throughout the ARV-471 treatment period, up to approximately 4 weeks after last dose of investigational products
Part C: Assessment of anti-tumor activity of ARV-471 in combination with palbociclib
Anti-tumor activity of ARV-471 in combination with palbociclib will be assessed by evaluating overall response rate per RECIST 1.1 in patients with measurable disease at baseline.
through study completion, up to approximately 2 years
Part C: Assessment of anti-tumor activity of ARV-471 in combination with palbociclib
Anti-tumor activity of ARV-471 in combination with palbociclib will be assessed by evaluating clinical benefit response (CBR) rate based on the summation of complete responses (CRs), partial responses (PRs) and stable disease of 24 weeks duration or longer.
through study completion, up to approximately 2 years
Part C: Assessment of anti-tumor activity of ARV-471 in combination with palbociclib
Anti-tumor activity of ARV-471 in combination with palbociclib will be assessed by evaluating time to event endpoints: progression free survival, duration of response.
through study completion, up to approximately 2 years
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Sponsor: Arvinas Estrogen Receptor, Inc.
Collaborator: Pfizer
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number: