PF-07220060
DrugCDK4 inhibitor
NCT Number: NCT04557449
This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy.
The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.
In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively).
In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A.
Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC.
Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively.
Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide.
Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants.
The Japan monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as a single agent in Japanese participants.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Hospital Británico de Buenos Aires, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CDK4 inhibitor
Endocrine Therapy
Other names: Femara
Endocrine Therapy
Other names: Faslodex
Benzodiazepine used for DDI
Androgen Receptor inhibitor
Other names: Xtandi
Time frame: Baseline up to day 28 of Cycle 1.
First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)
Time frame: Weekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days
Adverse Events
Time frame: Weekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months
safety laboratory abnormalities
Time frame: Day 1, Day 8, Day 15 of Cycle 1 and starting from Cycle 2, and then every 28 days through study completion, up to approximately 24 months (Each cycle is 28 days)
vital signs and heart rate corrected QT interval
Time frame: Day -7 through the end of Cycle 1
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D)
Time frame: D1 to the end of Cycle 1
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Time Frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)
Time frame: baseline up to approximately 24 months
Per RECIST v1.1 (Part 1 A-E; Part 2B and 2C); per PCWG3 (Part 1F and Part 2D)
Time frame: baseline up to approximately 24 months
Per RECIST v1.1
Time frame: baseline up to approximately 24 months
PFS per RECIST v.1.1
Time frame: baseline up to approximately 24 months
TTP per RECIST v1.1
Time frame: baseline up to approximately 24 months
CBR per RECIST v1.1 (Parts 2B, 2C)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Peak and trough concentration (Parts 2B, 2C, 2D)
Time frame: Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Peak and trough concentrations (Part 2D)
Time frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
Time to first skeletal events (Part 2D)
Time frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
time to functional status deterioration by FACT-P (Part 2D)
Time frame: Cycle 1 (each cycle is 28 days) up to approximately 24 months
Part 2D
Time frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
Part 1F and 2D
Pfizer
Industry
A PHASE 1/2A STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF PF-07220060 AS A SINGLE AGENT AND AS PART OF COMBINATION THERAPY IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
Acronym: CDK4i
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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