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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasms; Prostate Cancer; Adenocarcinoma of Lung; Liposarcoma
• Intervention / Treatment: Drug: PF-07220060; Combination product: Letrozole; Combination product: Fulvestrant; Combination product: Enzalutamide; Drug: Midazolam

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: Interventional
• Enrollment (Actual): 362
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1426ABP
    • Fundación Respirar
  • Córdoba, Argentina, X50004FHP
    • Clínica Universitaria Reina Fabiola
  • La Rioja, Argentina, F5300COE
    • Fundación CORI para la Investigación y Prevención del Cáncer
  • Buenos Aires
    • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
      • Hospital Britanico de Buenos Aires
  • Ciudad Autã³noma de Buenos Aires
    • CABA, Ciudad Autã³noma de Buenos Aires, Argentina, 1125
      • Fundación Cenit para la Investigación en Neurociencias
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Cancer Hospital Chinese Academy of Medical Science
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
• Czechia
  • Olomouc, Czechia, 779 00
    • Fakultni Nemocnice Olomouc
  • Prague, Czechia, 12808
    • Vseobecna Fakultni Nemocnice V Praze
• Japan
  • Chiba
    • Kashiwa, Chiba, Japan, 277-8577
      • National Cancer Center Hospital East
• Mexico
  • Oaxaca City, Mexico, 68000
    • Oaxaca Site Management Organization
  • Mexico City
    • Mexico City, Mexico City, Mexico, 04700
      • Hospital MAC Periferico Sur
    • Mexico City, Mexico City, Mexico, 14080
      • INCAN
    • Mexico City, Mexico City, Mexico
      • COI Centro Oncologico Internacional S.A.P.I. de C.V.
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
  • Oaxaca
    • Oaxaca City, Oaxaca, Mexico, 68000
      • Hospital Reforma
• Slovakia
  • Bratislava, Slovakia, 833 10
    • Narodny Onkologicky Ustav
  • Bratislava, Slovakia, 812 50
    • Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA
  • Nové Zámky, Slovakia, 940 34
    • Fakultna nemocnica s poliklinikou Nove Zamky
  • Poprad, Slovakia, 058 01
    • POKO Poprad, s.r.o.
• United Kingdom
  • London, United Kingdom, W1G 6AD
    • Sarah Cannon Research Institute UK
  • Manchester, United Kingdom, M20 4BX
    • The Christie Hospital NHS Foundation Trust
  • Edinburgh, CITY of
    • Edinburgh, Edinburgh, CITY of, United Kingdom, EH4 2XR
      • Cancer Research UK Edinburgh Centre
  • London, CITY of
    • London, London, CITY of, United Kingdom, EC1A 7BE
      • St Bartholomew'S Hospital
• United States
  • California
    • Los Angeles, California, United States, 90064
      • Ellison Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Smilow Cancer Hospital Phase 1 Unit
    • New Haven, Connecticut, United States, 06510
      • Smilow Cancer Hospital at Yale - New Haven
    • New Haven, Connecticut, United States, 06510
      • Yale-New Haven Hospital-Yale Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02115
      • Brigham & Women's Hospital
    • Newton, Massachusetts, United States, 02459
      • Dana Farber Cancer Institute- Chestnut Hill
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • START Midwest
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute - Pharmacy
    • Nashville, Tennessee, United States, 37203
      • SCRI Oncology Partners
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

17

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1A Monotherapy Escalation Arm 1; PF-07220060 Monotherapy Escalation	Drug: PF-07220060; CDK4 inhibitor
Experimental: 1A Monotherapy Escalation Arm 2; PF-07220060 Monotherapy Escalation	Drug: PF-07220060; CDK4 inhibitor
Experimental: 1A Monotherapy Escalation Arm 3; PF-07220060 Monotherapy Escalation	Drug: PF-07220060; CDK4 inhibitor
Experimental: 1A Monotherapy Escalation Arm 4; PF-07220060 Monotherapy Escalation	Drug: PF-07220060; CDK4 inhibitor
Experimental: 1B Combination Dose Finding Arm 1; PF-07220060 with Letrozole combination Escalation	Drug: PF-07220060; CDK4 inhibitor; Combination product: Letrozole; Endocrine Therapy; Other Names: Femara
Experimental: 1B Combination Dose Finding Arm 2; PF-07220060 with Letrozole Combination Escalation	Drug: PF-07220060; CDK4 inhibitor; Combination product: Letrozole; Endocrine Therapy; Other Names: Femara
Experimental: 1C Combination Dose Finding Arm 1; PF-07220060 with Fulvestrant Combination Escalation	Drug: PF-07220060; CDK4 inhibitor; Combination product: Fulvestrant; Endocrine Therapy; Other Names: Faslodex
Experimental: 1C Combination Dose Finding Arm 2; PF-07220060 with Fulvestrant Combination Escalation	Drug: PF-07220060; CDK4 inhibitor; Combination product: Fulvestrant; Endocrine Therapy; Other Names: Faslodex
Experimental: 2B Combination Dose Expansion; PF-07220060 with Letrozole Combination Expansion	Drug: PF-07220060; CDK4 inhibitor; Combination product: Letrozole; Endocrine Therapy; Other Names: Femara
Experimental: 2C Combination Dose Expansion; PF-07220060 with fulvestrant Combination Expansion	Drug: PF-07220060; CDK4 inhibitor; Combination product: Fulvestrant; Endocrine Therapy; Other Names: Faslodex
Experimental: 1D Monotherapy Food Effect; PF-07220060 Monotherapy Food Effect	Drug: PF-07220060; CDK4 inhibitor
Experimental: 1A Monotherapy Escalation Arm 5; PF-07220060 Monotherapy Escalation	Drug: PF-07220060; CDK4 inhibitor
Experimental: 1F Combination Dose Finding; PF-07220060 with Enzalutamide Escalation	Drug: PF-07220060; CDK4 inhibitor; Combination product: Enzalutamide; Androgen Receptor inhibitor; Other Names: Xtandi
Experimental: 1E DDI Cohort; PF-07220060 DDI with Midazolam	Drug: PF-07220060; CDK4 inhibitor; Drug: Midazolam; Benzodiazepine used for DDI
Experimental: 2D Combination Dose Expansion; PF-07220060 with enzalutamide Combination Expansion	Drug: PF-07220060; CDK4 inhibitor; Combination product: Enzalutamide; Androgen Receptor inhibitor; Other Names: Xtandi
Experimental: 2A Combination Dose Expansion; PF-07220060 with fulvestrant combination dose expansion	Drug: PF-07220060; CDK4 inhibitor; Combination product: Fulvestrant; Endocrine Therapy; Other Names: Faslodex
Experimental: 2E Combination Dose Expansion; PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy	Drug: PF-07220060; CDK4 inhibitor; Combination product: Fulvestrant; Endocrine Therapy; Other Names: Faslodex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of clinically significant AEs	Adverse Events	Weekly during Cycle 1 and 2 and then every 28 days through study completion, up to approximately 24 months; Each cycle is 28 days
Incidence of clinically significant laboratory assessments	safety laboratory abnormalities	Weekly during Cycle 1 and 2 (each cycle is 28 days) and then every 28 days through study completion, up to approximately 24 months
Food Effect	Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D)	Day -7 through the end of Cycle 1
Number of participants with dose limiting toxicities in the Dose Escalation Portion	First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)	Baseline up to day 28 of Cycle 1.
Incidence of clinically significant abnormal vital and ECG parameters	vital signs and heart rate corrected QT interval	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)
DDI	Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)	D1 to the end of Cycle 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Single Dose: Maximal concentration (Cmax) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Single Dose: Time to Maximum Plasma Concentration (Tmax) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
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	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
Apparent Oral Plasma Clearance (CL/F) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Single Dose: Apparent Volume of Distribution (Vz/F) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Steady State Maximal Concentration (Css,max) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Time to Maximum Plasma Concentration at Steady State (Tss,max) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCss,t) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Steady State Minimum Plasma Concentration (Css,min) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Steady State Apparent Oral Plasma Clearance (CLss/F) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Apparent Volume of Distribution at Steady State (Vss/F) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Terminal Elimination Half-Life (t1/2) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Multiple Dose: Accumulation Ratio (Rac (AUCss,t /AUCsd,t)) in the Dose Escalation and Dose Finding portion	Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Duration of Response (DOR)	Per RECIST v1.1	baseline up to approximately 24 months
Progression Free Survival (PFS)	PFS per RECIST v.1.1	baseline up to approximately 24 months
Time to Progression (TTP)	TTP per RECIST v1.1	baseline up to approximately 24 months
Clinical Benefit Rate (CBR)	CBR per RECIST v1.1 (Parts 2B, 2C)	baseline up to approximately 24 months
Tumor Response per RECIST v1.1 and per PCGW3	Per RECIST v1.1 (Part 1 A-E; Part 2B and 2C); per PCWG3 (Part 1F and Part 2D)	baseline up to approximately 24 months
Peak and Trough Concentration of PF-07220060	Peak and trough concentration (Parts 2B, 2C, 2D)	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 of enzalutamide and N-desmethyl enzalutamide	Peak and trough concentrations (Part 2D)	Cycle 1 (each cycle is 28 days) and Day 1 of each subsequent cycle and at study completion visit, up to approximately 24 months
Time to first skeletal events	Time to first skeletal events (Part 2D)	Cycle 1 (each cycle is 28 days) to up to approximately 24 months
Quality of life questionnaire	time to functional status deterioration by FACT-P (Part 2D)	Cycle 1 (each cycle is 28 days) to up to approximately 24 months
Radiographic Progression Free survival	Part 2D	Cycle 1 (each cycle is 28 days) up to approximately 24 months
PSA50	Part 1F and 2D	Cycle 1 (each cycle is 28 days) to up to approximately 24 months

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Estimated): September 23, 2026
• Study Completion (Estimated): November 23, 2027

Study Registration Dates

• First Submitted: September 15, 2020
• First Submitted That Met QC Criteria: September 15, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; enzalutamide; Solid Tumors; letrozole; Colorectal Cancer (CRC); fulvestrant; endocrine therapy; CDK4 inhibitor
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Colonic Diseases; Lung Neoplasms; Skin Diseases; Breast Diseases; Carcinoma; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms, Adipose Tissue; Skin and Connective Tissue Diseases; Adenocarcinoma of Lung; Prostatic Neoplasms; Colorectal Neoplasms; Breast Neoplasms; Liposarcoma; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Nitriles; Benzazepines; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Benzodiazepines; Triazoles; Letrozole; Fulvestrant; Midazolam; enzalutamide
• Other Study ID Numbers: C4391001; 2024-512120-11-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No