LiposarcomaPhase 1/2CDK4iNCT04557449
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
A Phase 1/2 study testing PF-07220060, Letrozole and Fulvestrant in people with Liposarcoma and Prostate Cancer, run by Pfizer at 39 sites in 8 countries.
Trial 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 in combination with endocrine therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liposarcoma, Prostate Cancer, Advanced Breast Cancer
- What is being tested?
- PF-07220060, Letrozole and Fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 39 sitesin 8 countries
- Study dates
- 23 Sep 2020to 7 Oct 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part 1: Breast Cancer (BC)
- Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC
- Part 1A/Part 1D/Part 1E 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 1G: HR-positive/HER2-negative BC
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- Part 2A, 2B, 2C, 2E, and 2F: HR-positive/HER2-negative BC
- Part 1D: metastatic castration resistant prostate cancer
- Giredestrant Combination Cohort: ER-positive/HER2-negative BC
- 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
- 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: 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: no 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 1G and 2F: at least 2 lines of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
- Giredestrant Combination Cohort: at least 1 (no more than 3) prior line(s) of SOC for advanced or metastatic disease, including CDK4/6 inhibitor and endocrine therapy
- 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
Who cannot join
- 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; Part 1G and 2F: tamoxifen treatment within 35 days of Day -4
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- Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry
- Part 1G and 2F: history of or current pulmonary embolism or deep vein thrombosis
- Giredestrant Combination Cohort: history (within 6 months of screening) of or presence of idiopathic symptomatic bradycardia or resting heart rate <50 bpm at screening
- 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
Trial locations and contacts
39 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
39 sites in 8 countries
United States14 sites, 10 recruiting
- Active, not recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
- Active, not recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
The University of Texas, MD Anderson Cancer Center - West Houston
Houston, Texas, 77079
- Active, not recruiting
Ellison Institute
Los Angeles, California, 90064
- Recruiting
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee, 37203
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Smilow Cancer Hospital - Yale New Haven Health
New Haven, Connecticut, 06510
- Recruiting
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, 06510
- Recruiting
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut, 06511
- Recruiting
Yale University - Smilow Cancer Hospital; C/O Thomas Ferencz, RPh, BCOP
New Haven, Connecticut, 06511
- Active, not recruiting
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts, 02467
- Recruiting
Smilow Cancer Hospital - Trumbull
Trumbull, Connecticut, 06611
Mexico6 sites
- Active, not recruiting
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, Mexico City, 04700
- Active, not recruiting
Hospital MAC Periferico Sur
Mexico City, Mexico City, 04700
- Active, not recruiting
INCAN
Mexico City, Mexico City, 14080
- Active, not recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460
- Active, not recruiting
Hospital Reforma
Oaxaca City, Oaxaca, 68000
- Active, not recruiting
Oaxaca Site Management Organization
Oaxaca City, 68000
Argentina5 sites
- Active, not recruiting
Fundación Respirar
Buenos Aires, C1426ABP
- Active, not recruiting
Fundación Cenit Para La Investigación En Neurociencias
CABA, Ciudad Autã³noma de Buenos Aires, 1125
- Active, not recruiting
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280
- Active, not recruiting
Clínica Universitaria Reina Fabiola
Córdoba, X50004FHP
- Active, not recruiting
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE
China5 sites
- Active, not recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
- Active, not recruiting
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
- Active, not recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Active, not recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
- Active, not recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450008
United Kingdom4 sites
- Active, not recruiting
Cancer Research UK Edinburgh Centre
Edinburgh, Edinburgh, CITY of, EH4 2XR
- Active, not recruiting
St Bartholomew's Hospital
London, London, CITY of, EC1A 7BE
- Active, not recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
- Active, not recruiting
The Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
Slovakia3 sites
- Active, not recruiting
Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA
Bratislava, 812 50
- Active, not recruiting
Narodny onkologicky ustav
Bratislava, 833 10
- Active, not recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, 940 34
Czechia1 site
- Active, not recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Japan1 site
- Active, not recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 277-8577
About this study
Official title: 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 in combination with endocrine therapy.
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.
Read more
Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide.
The Giredestrant Combination Cohort will evaluate PF-07220060 in combination with giredestrant.
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 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 doses of PF-07220060 will be administered in combination with enzalutamide.
In Part 1G, PF-07220060 will be administered in combination with tamoxifen to determine the RDE.
Part 2A is an expansion cohort for PF-07220060 in combination with fulvestrant and will explore more than one dose of PF-07220060.
Part 2B and Part 2C are expansion cohorts for PF-07220060 in combination with letrozole and fulvestrant, respectively.
Part 2E is an expansion cohort to evaluate PF-07220060 Monotherapy versus PF-07220060 plus fulvestrant combination therapy.
Part 2F is an expansion cohort for PF-07220060 in combination with tamoxifen. The Giredestrant Combination Cohort Group A will determine the tolerable dose of PF-07220060 in combination with giredestrant. In Group B, additional participants will be enrolled at the tolerable dose to further assess safety and PK.
The China and Japan monotherapy cohorts will evaluate safety, tolerability, and PK of PF-07220060 as single agent in Chinese and Japanese participants, respectively.
- Conditions
- Liposarcoma, Prostate Cancer, Advanced Breast Cancer, NSCLC (Non-small Cell Lung Cancer), Colorectal Cancer
- Being tested
- PF-07220060, Letrozole, Fulvestrant, Midazolam, Enzalutamide
- Keywords
- CDK4 inhibitor, Breast cancer, enzalutamide, fulvestrant, letrozole, endocrine therapy, Colorectal Cancer (CRC), Solid Tumors, giredestrant, tamoxifen
- Medical subject headings
- Liposarcoma, Prostatic Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-07220060Drug
CDK4 inhibitor
LetrozoleCombination product
Also called Femara
Endocrine Therapy
FulvestrantCombination product
Also called Faslodex
Endocrine Therapy
MidazolamOther
Benzodiazepine
EnzalutamideCombination product
Also called Xtandi
Androgen Receptor inhibitor
GiredestrantCombination product
Endocrine Therapy
TamoxifenCombination product
Endocrine Therapy
| Study group | Role | What they receive |
|---|---|---|
| 1A Monotherapy Escalation Arm 1 | Experimental | PF-07220060 Monotherapy Escalation Receives: Drug: PF-07220060 |
| 1A Monotherapy Escalation Arm 2 | Experimental | PF-07220060 Monotherapy Escalation Receives: Drug: PF-07220060 |
| 1A Monotherapy Escalation Arm 3 | Experimental | PF-07220060 Monotherapy Escalation Receives: Drug: PF-07220060 |
| 1A Monotherapy Escalation Arm 4 | Experimental | PF-07220060 Monotherapy Escalation Receives: Drug: PF-07220060 |
| 1A Monotherapy Escalation Arm 5 | Experimental | PF-07220060 Monotherapy Escalation Receives: Drug: PF-07220060 |
| 1B Combination Dose Finding Arm 1 | Experimental | PF-07220060 with Letrozole combination Escalation Receives: Drug: PF-07220060; Combination Product: Letrozole |
| 1B Combination Dose Finding Arm 2 | Experimental | PF-07220060 with Letrozole Combination Escalation Receives: Drug: PF-07220060; Combination Product: Letrozole |
| 1C Combination Dose Finding Arm 1 | Experimental | PF-07220060 with Fulvestrant Combination Escalation Receives: Drug: PF-07220060; Combination Product: Fulvestrant |
| 1C Combination Dose Finding Arm 2 | Experimental | PF-07220060 with Fulvestrant Combination Escalation Receives: Drug: PF-07220060; Combination Product: Fulvestrant |
| 1D Monotherapy Food Effect | Experimental | PF-07220060 Monotherapy Food Effect Receives: Drug: PF-07220060 |
| 1E DDI Cohort | Other | PF-07220060 DDI with Midazolam Receives: Drug: PF-07220060; Other: Midazolam |
| 1F Combination Dose Finding | Experimental | PF-07220060 with Enzalutamide Escalation Receives: Drug: PF-07220060; Combination Product: Enzalutamide |
| 1G Combination Dose Finding Arm 1 | Experimental | PF-07220060 with Tamoxifen Combination De-Escalation Receives: Drug: PF-07220060; Combination Product: Tamoxifen |
| 2A Combination Dose Expansion | Experimental | PF-07220060 with fulvestrant combination expansion Receives: Drug: PF-07220060; Combination Product: Fulvestrant |
| 2B Combination Dose Expansion | Experimental | PF-07220060 with Letrozole Combination Expansion Receives: Drug: PF-07220060; Combination Product: Letrozole |
| 2C Combination Dose Expansion | Experimental | PF-07220060 with fulvestrant Combination Expansion Receives: Drug: PF-07220060; Combination Product: Fulvestrant |
| 2E Combination Dose Expansion | Experimental | PF-07220060 Monotherapy OR PF-07220060 plus fulvestrant combination therapy Receives: Drug: PF-07220060; Combination Product: Fulvestrant |
| 2F Combination Dose Expansion | Experimental | PF-07220060 with Tamoxifen Combination Expansion Receives: Drug: PF-07220060; Combination Product: Tamoxifen |
| Giredestrant Combination Cohort (Group A) | Experimental | PF-07220060 with Giredestrant Combination Receives: Drug: PF-07220060; Combination Product: Giredestrant |
| Giredestrant Combination Cohort (Group B) | Experimental | PF-07220060 with Giredestrant Combination Receives: Drug: PF-07220060; Combination Product: Giredestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with dose limiting toxicities in the Dose Escalation or De-escalation Portion
First cycle (28 days) dose limiting toxicities
Measured: At the end of Cycle 1 (each cycle is 28 days)
Incidence of clinically significant AEs
Adverse Events
Measured: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
Incidence of clinically significant laboratory assessments
safety laboratory abnormalities
Measured: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
Incidence of clinically significant abnormal vital and ECG parameters
vital signs and heart rate corrected QT interval
Measured: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
Maximal Plasma Concentration (Cmax) of PF-07220060 given with and without food
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)
Measured: Cycle 1 (each cycle is 28 days)
Time to Maximum Plasma Concentration (Tmax) of PF-07220060 given with and without food
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)
Measured: Cycle 1 (each cycle is 28 days)
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Time Point (AUClast) of PF-07220060 given with and without food
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1D)
Measured: Cycle 1 (each cycle is 28 days)
Maximal Plasma Concentration (Cmax) of Midazolam with and without PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)
Measured: Cycle 1 (each cycle is 28 days)
Time to Maximum Plasma Concentration (Tmax) of Midazolam with and without PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)
Measured: Cycle 1 (each cycle is 28 days)
Area Under the Plasma Concentration Versus Time Curve from Time Zero to the Last Sampling Timepoint (AUClast) of Midazolam with and without PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Part 1E)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Maximal Concentration (Cmax,ss) of PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Time to Maximum Plasma Concentration (Tmax,ss) of PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Minimum Plasma Concentration (Cmin,ss) of PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Maximal Concentration (Cmax,ss) of Giredestrant
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Time to Maximum Plasma Concentration (Tmax,ss) of Giredestrant
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCτ,ss) of Giredestrant
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Steady State Minimum Plasma Concentration (Cmin,ss) of Giredestrant
Pharmacokinetic (PK) assessments (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days)
Secondary outcomes (21)
Single Dose: Maximal Plasma Concentration (Cmax) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1F)
Measured: Cycle 1 (each cycle is 28 days)
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, 1F)
Measured: Cycle 1 (each cycle is 28 days)
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, 1F)
Measured: Cycle 1 (each cycle is 28 days)
Multiple Dose: Steady State Maximal Concentration (Cmax,ss) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)
Measured: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
Multiple Dose: Steady State Time to Maximum Plasma Concentration (Tmax,ss) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)
Measured: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCt,ss) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)
Measured: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
Multiple Dose: Steady State Minimum Plasma Concentration (Cmin,ss) in the Dose Escalation and Dose Finding portion
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 1A, 1B, 1C, 1E, 1F, 1G)
Measured: Cycle 1 (each cycle is 28 days) for Parts 1A/1B/1C/1E/1F; Cycle 2 (each cycle is 28 days) for Part 1G
Steady State Peak Concentration of Enzalutamide and N-desmethyl Enzalutamide
Pharmacokinetic (PK) assessments for enzalutamide (Part 1F)
Measured: Cycles 1 - 12 (each cycle is 28 days)
Steady State Trough Concentration of Enzalutamide and N-desmethyl Enzalutamide
Pharmacokinetic (PK) assessments for enzalutamide (Part 1F)
Measured: Cycle 3 (each cycle is 28 days)
Tumor Response per RECIST v1.1 and per PCGW3
Per RECIST v1.1 (all cohorts except for Part 1F); per PCWG3 (Part 1F)
Measured: baseline up to approximately 24 months
Duration of Response (DOR)
Per RECIST v1.1
Measured: baseline up to approximately 24 months
Progression Free Survival (PFS)
PFS per RECIST v.1.1
Measured: baseline up to approximately 24 months
Clinical Benefit Rate (CBR)
CBR per RECIST v1.1
Measured: baseline up to approximately 24 months
PSA50
Part 1F
Measured: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
Incidence of clinically significant AEs
Adverse Events (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
Incidence of clinically significant laboratory assessments
Safety laboratory abnormalities (Giredestrant Combination Cohort)
Measured: Cycle 1 (each cycle is 28 days) through study completion, up to approximately 24 months
Steady State Minimal Concentration (Cmin,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen
Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)
Measured: Cycle 2 (each cycle is 28 days)
Metabolite to Parent Ratio of Minimal Concentration (MRCmin) of 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen
Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)
Measured: Cycle 2 (each cycle is 28 days)
Steady State Area Under the Plasma Concentration Versus Time Curve Within One Dose Interval (AUCt,ss) of Tamoxifen, 4-hydroxy-tamoxifen, N-desmethyltamoxifen, and Endoxifen
Pharmacokinetic (PK) assessments for tamoxifen and metabolites (Parts 1G and 2F)
Measured: Cycle 2 (each cycle is 28 days)
Steady State Peak Concentration of PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Part 2A, 2B, 2C, 2E, 2F)
Measured: Cycle 1 (each cycle is 28 days) for Part 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F
Steady State Trough Concentration of PF-07220060
Pharmacokinetic (PK) assessments for PF-07220060 (Parts 2A, 2B, 2C, 2E, 2F)
Measured: Cycle 1 (each cycle is 28 days) for Parts 2A/2B/2C/2E; Cycle 2 (each cycle is 28 days) for Part 2F
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start23 Sep 2020
- Primary completion7 Oct 2029 (estimated)
- Study completion7 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiposarcomaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557449
- Sponsor's protocol ID
- C4391001
- Other IDs
- 2020-002938-33, 2024-512120-11-00
- Acronym
- CDK4i
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2020
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.