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Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors (CDK4i)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04557449
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : April 30, 2024
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE September 15, 2020
First Posted Date  ICMJE September 21, 2020
Last Update Posted Date April 30, 2024
Actual Study Start Date  ICMJE September 23, 2020
Estimated Primary Completion Date March 5, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2023)
  • Number of participants with dose limiting toxicities in the Dose Escalation Portion [ Time Frame: Baseline up to day 28 of Cycle 1. ]
    First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)
  • Incidence of clinically significant AEs [ 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
  • Incidence of clinically significant laboratory assessments [ 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
  • Incidence of clinically significant abnormal vital and ECG parameters [ 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
  • Food Effect [ Time Frame: Day -7 through the end of Cycle 1 ]
    Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D)
  • DDI [ Time Frame: D1 to the end of Cycle 1 ]
    Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)
Original Primary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Number of participants with dose limiting toxicities in the Dose Escalation Portion [ Time Frame: Baseline up to day 28 of Cycle 1. ]
  • Incidence of clinically significant AEs [ 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
  • Incidence of clinically significant laboratory assessments [ 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
  • Incidence of clinically significant abnormal vital and ECG parameters [ 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2023)
  • Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion [ 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)
  • Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion [ 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)
  • 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 [ 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)
  • 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 [ 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)
  • Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion [ 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)
  • Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion [ 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)
  • Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion [ 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)
  • Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion [ 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)
  • Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion [ 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)
  • Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion [ 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)
  • Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion [ 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)
  • Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion [ 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)
  • Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion [ 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)
  • Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion [ 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)
  • Tumor Response per RECIST v1.1 and per PCGW3 [ 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)
  • Duration of Response (DOR) [ Time Frame: baseline up to approximately 24 months ]
    Per RECIST v1.1
  • Progression Free Survival (PFS) [ Time Frame: baseline up to approximately 24 months ]
    PFS per RECIST v.1.1
  • Time to Progression (TTP) [ Time Frame: baseline up to approximately 24 months ]
    TTP per RECIST v1.1
  • Clinical Benefit Rate (CBR) [ Time Frame: baseline up to approximately 24 months ]
    CBR per RECIST v1.1 (Parts 2B, 2C)
  • Peak and Trough Concentration of PF-07220060 [ 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)
  • Peak and trough concentrations of enzalutamide and N-desmethyl enzalutamide [ 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 to first skeletal events [ Time Frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months ]
    Time to first skeletal events (Part 2D)
  • Quality of life questionnaire [ 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)
  • Radiographic Progression Free survival [ Time Frame: Cycle 1 (each cycle is 28 days) up to approximately 24 months ]
    Part 2D
  • PSA50 [ Time Frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months ]
    Part 1F and 2D
Original Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2020)
  • Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion [ 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
  • Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion [ 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
  • 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 [ 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
  • 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 [ 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
  • Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion [ 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
  • Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion [ 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
  • Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion [ 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
  • Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion [ 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
  • Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion [ 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
  • Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion [ 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
  • Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion [ 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
  • Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion [ 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
  • Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion [ 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
  • Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion [ 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
  • Tumor Response observed in participants in Dose Escalation and Dose Finding portion [ Time Frame: baseline up to approximately 24 months ]
  • Duration of Response (DOR) in participants enrolled in the Dose Escalation and Dose Finding portion [ Time Frame: baseline up to approximately 24 months ]
  • Progression Free Survival (PFS) observed in participants in the Dose Escalation and Dose Finding portion [ Time Frame: baseline up to approximately 24 months ]
  • Time to Progression (TTP) observed in participants enrolled in the Dose Escalation and Dose Finding portion [ Time Frame: baseline up to approximately 24 months ]
  • Overall Survival observed in participants enrolled in the Dose Expansion Arms [ Time Frame: baseline up to approximately 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Liposarcoma
  • CRC
  • Prostate Cancer
  • Breast Neoplasms
  • Adenocarcinoma of Lung
  • Solid Tumors
Intervention  ICMJE
  • Drug: PF-07220060
    CDK4 inhibitor
  • Combination Product: Letrozole
    Endocrine Therapy
    Other Name: Femara
  • Combination Product: Fulvestrant
    Endocrine Therapy
    Other Name: Faslodex
  • Drug: Midazolam
    Benzodiazepine used for DDI
  • Combination Product: Enzalutamide
    Androgen Receptor inhibitor
    Other Name: Xtandi
Study Arms  ICMJE
  • Experimental: 1A Monotherapy Escalation Arm 1
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: 1A Monotherapy Escalation Arm 2
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: 1A Monotherapy Escalation Arm 3
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: 1A Monotherapy Escalation Arm 4
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: 1B Combination Dose Finding Arm 1
    PF-07220060 with Letrozole combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Letrozole
  • Experimental: 1B Combination Dose Finding Arm 2
    PF-07220060 with Letrozole Combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Letrozole
  • Experimental: 1C Combination Dose Finding Arm 1
    PF-07220060 with Fulvestrant Combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Fulvestrant
  • Experimental: 1C Combination Dose Finding Arm 2
    PF-07220060 with Fulvestrant Combination Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Fulvestrant
  • Experimental: 2B Combination Dose Expansion
    PF-07220060 with Letrozole Combination Expansion
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Letrozole
  • Experimental: 2C Combination Dose Expansion
    PF-07220060 with fulvestrant Combination Expansion
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Fulvestrant
  • Experimental: 1D Monotherapy Food Effect
    PF-07220060 Monotherapy Food Effect
    Intervention: Drug: PF-07220060
  • Experimental: 1A Monotherapy Escalation Arm 5
    PF-07220060 Monotherapy Escalation
    Intervention: Drug: PF-07220060
  • Experimental: 1F Combination Dose Finding
    PF-07220060 with Enzalutamide Escalation
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Enzalutamide
  • Experimental: 1E DDI Cohort
    PF-07220060 DDI with Midazolam
    Interventions:
    • Drug: PF-07220060
    • Drug: Midazolam
  • Experimental: 2D Combination Dose Expansion
    PF-07220060 with enzalutamide Combination Expansion
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Enzalutamide
  • Experimental: 2A Combination Dose Expansion
    PF-07220060 with fulvestrant combination dose expansion
    Interventions:
    • Drug: PF-07220060
    • Combination Product: Fulvestrant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 3, 2023)		 337
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2020)		 52
Estimated Study Completion Date  ICMJE May 4, 2028
Estimated Primary Completion Date March 5, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and 2C:

    • 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 and 2C: 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: 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Argentina,   China,   Czechia,   Japan,   Mexico,   Slovakia,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04557449
Other Study ID Numbers  ICMJE C4391001
2020-002938-33 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Current Responsible Party Pfizer
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP