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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.

Clinical Trial Details

Geo Regions

Category

Breast Cancer

Category

Genitourinary Cancer

Category

Other or Multiple Cancer Types

Atirmociclib (PF-07220060)

Atirmociclib (PF-07220060) is an investigational compound. Its safety and efficacy have not been established.

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

Phase 1 /2

NCT04557449

Active enrolling

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Locations

United States, Argentina, China, Czechia, Japan, Mexico, Slovakia, United Kingdom

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Study design
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 1

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 2

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 3

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 4

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1B Combination Dose Finding Arm 1

PF-07220060 with Letrozole combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1B Combination Dose Finding Arm 2

PF-07220060 with Letrozole Combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1C Combination Dose Finding Arm 1

PF-07220060 with Fulvestrant Combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1C Combination Dose Finding Arm 2

PF-07220060 with Fulvestrant Combination Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2B Combination Dose Expansion

PF-07220060 with Letrozole Combination Expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2C Combination Dose Expansion

PF-07220060 with fulvestrant Combination Expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1D Monotherapy Food Effect

PF-07220060 Monotherapy Food Effect

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1A Monotherapy Escalation Arm 5

PF-07220060 Monotherapy Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1F Combination Dose Finding

PF-07220060 with Enzalutamide Escalation

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 1E DDI Cohort

PF-07220060 DDI with Midazolam

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor

DRUG: Midazolam

Benzodiazepine used for DDI
Participant Group/Arm

EXPERIMENTAL: 2D Combination Dose Expansion

PF-07220060 with enzalutamide Combination Expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2A Combination Dose Expansion

PF-07220060 with fulvestrant combination dose expansion

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Participant Group/Arm

EXPERIMENTAL: 2E Combination Dose Expansion

PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy

Intervention/Treatment

DRUG: PF-07220060

CDK4 inhibitor
Study design table for Clinical Trial
Key eligibility criteria
Inclusion criteria
Inclusion Criteria * Part 1: Breast Cancer (BC) * Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC * Part 1A/Part 1D/Part1E also include: Refractory HR-positive/HER2-positive BC * Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests * Part 1F: prostate cancer * Part 2A, 2B, 2C and 2E: * HR-positive/HER2-negative BC * Patients who are either postmenopausal women or pre/peri-menopausal (Part 2C only) * Part 1D: metastatic castration resistant prostate cancer * Lesion: * Part 1: evaluable lesion (including skin or bone lesion only) * Part 2A, 2B, 2C and 2E: measurable lesion per RECIST v1.1 * Part 2D: Participants with evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded. * Prior systemic Treatment * Part 1: HR-positive/HER2-negative BC * At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator * At least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease * HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy * Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available * Part 2A and 2E: participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed * Part 2B: participants who have not received any prior systemic anti-cancer therapies for advanced/metastatic BC * Part 2C: * Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or * Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal * One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy * Part 2D: * Received prior abiraterone; enzalutamide and CDK4i naive * 0-1 line of chemotherapy is allowed General Inclusion Criteria * All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1 * Adequate renal, liver, and bone marrow function
Exclusion criteria
* Part 1D: participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal * Part 2B: prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor * Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway * Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease * Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Major surgery or radiation within 4 weeks prior to study intervention * Last anti-cancer treatment within 2 weeks prior to study intervention * Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry * Pregnant or breastfeeding female participant * Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease
Key dates
Study start date
  • September 2020
Estimated Study Completion Date
  • November 2027
Key endpoints
Primary Outcome Measures
Outcome Measure

Number of participants with dose limiting toxicities in the Dose Escalation Portion

Measure Description

First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)

Time Frame

Baseline up to day 28 of Cycle 1.

Outcome Measure

Incidence of clinically significant AEs

Measure Description

Adverse Events

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

Outcome Measure

Incidence of clinically significant laboratory assessments

Measure Description

safety laboratory abnormalities

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

Outcome Measure

Incidence of clinically significant abnormal vital and ECG parameters

Measure Description

vital signs and heart rate corrected QT interval

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)

Outcome Measure

Food Effect

Measure Description

Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D)

Time Frame

Day -7 through the end of Cycle 1

Outcome Measure

DDI

Measure Description

Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)

Time Frame

D1 to the end of Cycle 1

Primary Outcome Measures table for Clinical Trial
Secondary Outcome Measures:
Outcome Measure

Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point Within the Dose Interval (AUClast) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Single Dose: Area Under the Plasma Concentration Versus Time Curve from Time Zero Extrapolated to Infinity (AUCinf) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion

Measure Description

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

Outcome Measure

Tumor Response per RECIST v1.1 and per PCGW3

Measure Description

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

Outcome Measure

Duration of Response (DOR)

Measure Description

Per RECIST v1.1

Time Frame

baseline up to approximately 24 months

Outcome Measure

Progression Free Survival (PFS)

Measure Description

PFS per RECIST v.1.1

Time Frame

baseline up to approximately 24 months

Outcome Measure

Time to Progression (TTP)

Measure Description

TTP per RECIST v1.1

Time Frame

baseline up to approximately 24 months

Outcome Measure

Clinical Benefit Rate (CBR)

Measure Description

CBR per RECIST v1.1 (Parts 2B, 2C)

Time Frame

baseline up to approximately 24 months

Outcome Measure

Peak and Trough Concentration of PF-07220060

Measure Description

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

Outcome Measure

Peak and trough concentrations of enzalutamide and N-desmethyl enzalutamide

Measure Description

Peak and trough concentrations (Part 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

Outcome Measure

Time to first skeletal events

Measure Description

Time to first skeletal events (Part 2D)

Time Frame

Cycle 1 (each cycle is 28 days) to up to approximately 24 months

Outcome Measure

Quality of life questionnaire

Measure Description

time to functional status deterioration by FACT-P (Part 2D)

Time Frame

Cycle 1 (each cycle is 28 days) to up to approximately 24 months

Outcome Measure

Radiographic Progression Free survival

Measure Description

Part 2D

Time Frame

Cycle 1 (each cycle is 28 days) up to approximately 24 months

Outcome Measure

PSA50

Measure Description

Part 1F and 2D

Time Frame

Cycle 1 (each cycle is 28 days) to up to approximately 24 months

Secondary Outcome Measures table for Clinical Trial
Number of participants

337

Collaborators and investigators

Sponsor: Pfizer

Collaborator: None

This information is current as of November 18th 2024.

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When calling, please reference this study number:

More Information Close 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. NCT04557449