- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04557449
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
Study Overview
Status
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
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Pfizer CT.gov Call Center
- Phone Number: 1-800-718-1021
- Email: ClinicalTrials.gov_Inquiries@pfizer.com
Study Locations
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Buenos Aires, Argentina, C1426ABP
- Recruiting
- Fundación Respirar
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Córdoba, Argentina, X50004FHP
- Recruiting
- Clinica Universitaria Reina Fabiola
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La Rioja, Argentina, F5300COE
- Recruiting
- Fundación CORI para la Investigación y Prevención del Cáncer
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Buenos Aires
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Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina, 1280
- Recruiting
- Hospital Británico de Buenos Aires
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Ciudad Autã³noma DE Buenos Aires
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Caba, Ciudad Autã³noma DE Buenos Aires, Argentina, 1125
- Recruiting
- Fundacion CENIT para la investigacion en Neurociencias
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Beijing
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Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital Chinese Academy of Medical Science
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Henan
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Zhengzhou, Henan, China, 450008
- Recruiting
- Henan Cancer Hospital
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Hubei
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Wuhan, Hubei, China, 430079
- Recruiting
- Hubei Cancer Hospital
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Shaanxi
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Xi'an, Shaanxi, China, 710061
- Not yet recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
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Shanxi
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Xi'an, Shanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
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Sichuan
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Chengdu, Sichuan, China, 610041
- Not yet recruiting
- West China Hospital of Sichuan University
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Recruiting
- Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine
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Ningbo, Zhejiang, China, 315010
- Not yet recruiting
- The first affiliated hospital of Ningbo University
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Wenzhou, Zhejiang, China, 325000
- Not yet recruiting
- The First Affiliated Hospital of Wenzhou Medical University
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Olomouc, Czechia, 779 00
- Recruiting
- Fakultní nemocnice Olomouc
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Praha 2, Czechia, 12808
- Recruiting
- Vseobecna fakultni nemocnice v Praze
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Chiba
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Kashiwa, Chiba, Japan, 277-8577
- Recruiting
- National Cancer Center Hospital East
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Oaxaca, Mexico, 68000
- Recruiting
- Oaxaca Site Management Organization
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Distrito Federal
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Cdmx, Distrito Federal, Mexico, 14080
- Recruiting
- INCAN
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Ciudad de Mexico, Distrito Federal, Mexico, 04700
- Recruiting
- Hospital MAC Periferico Sur
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Mexico City, Distrito Federal, Mexico
- Recruiting
- COI Centro Oncologico Internacional S.A.P.I. de C.V.
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Nuevo LEÓN
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Monterrey, Nuevo LEÓN, Mexico, 64460
- Recruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
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Oaxaca
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Oaxaca de Juárez, Oaxaca, Mexico, 68000
- Recruiting
- Hospital Reforma
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Bratislava, Slovakia, 833 10
- Recruiting
- Narodny Onkologicky Ustav
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Bratislava, Slovakia, 812 50
- Recruiting
- Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA
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Nove Zamky, Slovakia, 940 34
- Recruiting
- Fakultna nemocnica s poliklinikou Nove Zamky
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Poprad, Slovakia, 058 01
- Recruiting
- POKO Poprad, s.r.o.
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London, United Kingdom, W1G 6AD
- Recruiting
- Sarah Cannon Research Institute UK
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Manchester, United Kingdom, M20 4BX
- Recruiting
- The Christie Hospital NHS Foundation Trust
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Edinburgh, CITY OF
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Edinburgh, Edinburgh, CITY OF, United Kingdom, EH4 2XR
- Recruiting
- Cancer Research UK Edinburgh Centre
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London, CITY OF
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London, London, CITY OF, United Kingdom, EC1A 7BE
- Recruiting
- St Bartholomew's Hospital
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Connecticut
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New Haven, Connecticut, United States, 06510
- Recruiting
- Smilow Cancer Hospital at Yale - New Haven
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New Haven, Connecticut, United States, 06511
- Recruiting
- Smilow Cancer Hospital Phase 1 Unit
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute
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Boston, Massachusetts, United States, 02115
- Recruiting
- Brigham & Women's Hospital
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Boston, Massachusetts, United States, 02215
- Recruiting
- Dana-Farber Cancer Institute (DFCI)
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Newton, Massachusetts, United States, 02459
- Recruiting
- Dana Farber Cancer Institute- Chestnut Hill
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Michigan
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Grand Rapids, Michigan, United States, 49546
- Recruiting
- START Midwest
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Tennessee Oncology, PLLC
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Nashville, Tennessee, United States, 37203
- Recruiting
- Sarah Cannon Research Institute
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- The University of Texas MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1A Monotherapy Escalation Arm 1
PF-07220060 Monotherapy Escalation
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CDK4 inhibitor
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Experimental: 1A Monotherapy Escalation Arm 2
PF-07220060 Monotherapy Escalation
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CDK4 inhibitor
|
Experimental: 1A Monotherapy Escalation Arm 3
PF-07220060 Monotherapy Escalation
|
CDK4 inhibitor
|
Experimental: 1A Monotherapy Escalation Arm 4
PF-07220060 Monotherapy Escalation
|
CDK4 inhibitor
|
Experimental: 1B Combination Dose Finding Arm 1
PF-07220060 with Letrozole combination Escalation
|
CDK4 inhibitor
Endocrine Therapy
Other Names:
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Experimental: 1B Combination Dose Finding Arm 2
PF-07220060 with Letrozole Combination Escalation
|
CDK4 inhibitor
Endocrine Therapy
Other Names:
|
Experimental: 1C Combination Dose Finding Arm 1
PF-07220060 with Fulvestrant Combination Escalation
|
CDK4 inhibitor
Endocrine Therapy
Other Names:
|
Experimental: 1C Combination Dose Finding Arm 2
PF-07220060 with Fulvestrant Combination Escalation
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CDK4 inhibitor
Endocrine Therapy
Other Names:
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Experimental: 2B Combination Dose Expansion
PF-07220060 with Letrozole Combination Expansion
|
CDK4 inhibitor
Endocrine Therapy
Other Names:
|
Experimental: 2C Combination Dose Expansion
PF-07220060 with fulvestrant Combination Expansion
|
CDK4 inhibitor
Endocrine Therapy
Other Names:
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Experimental: 1D Monotherapy Food Effect
PF-07220060 Monotherapy Food Effect
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CDK4 inhibitor
|
Experimental: 1A Monotherapy Escalation Arm 5
PF-07220060 Monotherapy Escalation
|
CDK4 inhibitor
|
Experimental: 1F Combination Dose Finding
PF-07220060 with Enzalutamide Escalation
|
CDK4 inhibitor
Androgen Receptor inhibitor
Other Names:
|
Experimental: 1E DDI Cohort
PF-07220060 DDI with Midazolam
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CDK4 inhibitor
Benzodiazepine used for DDI
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Experimental: 2D Combination Dose Expansion
PF-07220060 with enzalutamide Combination Expansion
|
CDK4 inhibitor
Androgen Receptor inhibitor
Other Names:
|
Experimental: 2A Combination Dose Expansion
PF-07220060 with fulvestrant combination dose expansion
|
CDK4 inhibitor
Endocrine Therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
Time Frame: Day -7 through the end of Cycle 1
|
Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1D)
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Day -7 through the end of Cycle 1
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Number of participants with dose limiting toxicities in the Dose Escalation Portion
Time Frame: Baseline up to day 28 of Cycle 1.
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First cycle (28 days) dose limiting toxicities (Parts 1A, 1B, 1C, 1F)
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Baseline up to day 28 of Cycle 1.
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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
|
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
Time Frame: D1 to the end of Cycle 1
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Maximal Concentration, Time to Maximum Plasma Concentration, Area under the Plasma Concentration (Part 1E)
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D1 to the end of Cycle 1
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
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)
|
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
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)
|
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
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
|
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)
|
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
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)
|
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
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)
|
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
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)
|
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
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)
|
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
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)
|
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
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)
|
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
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)
|
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
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)
|
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
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)
|
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)
Time Frame: baseline up to approximately 24 months
|
Per RECIST v1.1
|
baseline up to approximately 24 months
|
Progression Free Survival (PFS)
Time Frame: baseline up to approximately 24 months
|
PFS per RECIST v.1.1
|
baseline up to approximately 24 months
|
Time to Progression (TTP)
Time Frame: baseline up to approximately 24 months
|
TTP per RECIST v1.1
|
baseline up to approximately 24 months
|
Clinical Benefit Rate (CBR)
Time Frame: baseline up to approximately 24 months
|
CBR per RECIST v1.1 (Parts 2B, 2C)
|
baseline up to approximately 24 months
|
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)
|
baseline up to approximately 24 months
|
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)
|
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
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)
|
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 Frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
|
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 Frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
|
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
Time Frame: Cycle 1 (each cycle is 28 days) up to approximately 24 months
|
Part 2D
|
Cycle 1 (each cycle is 28 days) up to approximately 24 months
|
PSA50
Time Frame: Cycle 1 (each cycle is 28 days) to up to approximately 24 months
|
Part 1F and 2D
|
Cycle 1 (each cycle is 28 days) to up to approximately 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Male
- Breast Diseases
- Prostatic Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Sarcoma
- Neoplasms, Adipose Tissue
- Urogenital Diseases
- Male Urogenital Diseases
- Genital Diseases, Male
- Genital Diseases
- Breast Neoplasms
- Prostatic Neoplasms
- Adenocarcinoma of Lung
- Liposarcoma
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Tranquilizing Agents
- Psychotropic Drugs
- Hypnotics and Sedatives
- Adjuvants, Anesthesia
- Anti-Anxiety Agents
- GABA Modulators
- GABA Agents
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Estrogen Receptor Antagonists
- Midazolam
- Letrozole
- Fulvestrant
Other Study ID Numbers
- C4391001
- 2020-002938-33 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Innocrin PharmaceuticalCompletedBreast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the BreastUnited States
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G1 Therapeutics, Inc.TerminatedBreast Cancer | Breast Neoplasm | Triple-Negative Breast Cancer | Triple-Negative Breast NeoplasmsUnited States, Bulgaria, Croatia, Slovenia, Serbia, Belgium, North Macedonia, Slovakia
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Seagen Inc.CompletedTriple Negative Breast Neoplasms | Hormone Receptor Positive Breast Neoplasms | HER2 Positive Breast Neoplasms | HER2 Mutations Breast NeoplasmsUnited States
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University of WashingtonNational Cancer Institute (NCI)CompletedInflammatory Breast Cancer | Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast CancerUnited States
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Sidney Kimmel Cancer Center at Thomas Jefferson...Celgene CorporationTerminatedInflammatory Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Recurrent Breast Cancer | HER2-negative Breast CancerUnited States
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Providence Health & ServicesBrooklyn ImmunoTherapeutics, LLCActive, not recruitingBreast Neoplasm | Triple Negative Breast Cancer | Breast Neoplasm, MaleUnited States
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Joseph Baar, MD, PhDCompletedBreast Cancer | Stage I Breast Cancer | Inflammatory Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast CancerUnited States
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Wake Forest University Health SciencesMerck Sharp & Dohme LLCCompletedMale Breast Cancer | Breast - FemaleUnited States
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GlaxoSmithKlineCompletedMetastatic Breast Cancer | Neoplasms, BreastJapan
Clinical Trials on PF-07220060
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PfizerActive, not recruitingHealthy ParticipantsNetherlands
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PfizerRecruitingBreast Cancer | Solid TumorsChina, United States, Bulgaria, Spain, Brazil, Czechia, Argentina, South Africa, Mexico
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PfizerArvinas Estrogen Receptor, Inc.RecruitingBreast CancerUnited States, Japan, Puerto Rico
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PfizerRecruitingHealthy ParticipantsUnited States
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PfizerRecruitingLocally Advanced or Metastatic ER+ HER2- Breast Cancer | Locally Advanced or Metastatic Castration-resistant Prostate Cancer | Locally Advanced or Metastatic Non-small Cell Lung CancerUnited States, China, Australia, Korea, Republic of, Japan
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PfizerCompleted
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PfizerCompleted
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University of FloridaCompletedGastrointestinal Symptoms | Stool Frequency | Gastrointestinal Transit TimeUnited States
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PfizerCompletedSchizophreniaUnited States