Phase
Condition
Prostate Cancer, Early, Recurrent
Prostate Cancer
Urologic Cancer
Treatment
Enzalutamide
Midazolam
PF-07220060
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Part 1: Breast Cancer (BC)
Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth FactorReceptor 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 amplificationaccording 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 2Conly)
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 withbone metastases only are allowed. Participants with biochemical recurrence onlyare excluded.
Prior systemic Treatment
Part 1: HR-positive/HER2-negative BC
At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced ormetastatic disease, or if CDK4/6 inhibitors are not considered appropriatein the opinion of the investigator
At least 1 line of anti-endocrine in countries without CDK4/6 inhibitorapproval or reimbursement, for advanced or metastatic disease
HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatmentof approved HER2 targeting therapy
Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to atleast 2 lines of SOC for advanced or recurrent disease or for which nostandard therapy is available
Part 2A and 2E: participants must have received at least 1 line of standard ofcare (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo isallowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed
Part 2B: participants who have not received any prior systemic anti-cancertherapies for advanced/metastatic BC
Part 2C:
Progressed during treatment or within 12 months of completion of adjuvanttherapy with an aromatase inhibitor if postmenopausal, or tamoxifen if preor perimenopausal, or
Progressed while on or within 1 month after the endo the prior aromataseinhibitor therapy for advanced/metastatic BC if postmenopausal or priorendocrine treatment for advanced/metastatic BC if pre or perimenopausal
One previous line of chemotherapy for advanced/metastatic disease isallowed 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 toprovide clinical benefit for their condition.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
Adequate renal, liver, and bone marrow function
Exclusion
Exclusion Criteria:
Part 1D: participants who have had a gastrectomy or have dietary or otherrestrictions 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 aromataseinhibitor with disease recurrence while on or within 12 months of completingtreatment. Prior treatment with any CDK4/6 inhibitor
Part 2C: prior treatment with any CDK inhibitor, fulvestrant, everolimus, or anyagent whose mechanism of action is to inhibit the PI3K-mTOR pathway
Known active uncontrolled or symptomatic Central Nervous System (CNS) metastasescarcinomatous meningitis, or leptomeningeal disease
Other active malignancy within 3 years prior to randomization, except for adequatelytreated 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 weeksprior to study entry
Pregnant or breastfeeding female participant
Active inflammatory gastrointestinal (GI) disease, known diverticular disease orprevious gastric resection or lap band surgery including impairment ofgastrointestinal function or GI disease
Study Design
Connect with a study center
Hospital Británico de Buenos Aires
Ciudad autónoma de Buenos Aires, Buenos Aires 1280
ArgentinaActive - Recruiting
Fundación Cenit Para La Investigación En Neurociencias
Caba, Ciudad Autã³noma DE Buenos Aires 1125
ArgentinaActive - Recruiting
Fundación Respirar
Buenos Aires, C1426ABP
ArgentinaActive - Recruiting
Clínica Universitaria Reina Fabiola
Córdoba, X50004FHP
ArgentinaActive - Recruiting
Fundación CORI para la Investigación y Prevención del Cáncer
La Rioja, F5300COE
ArgentinaActive - Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing 100021
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450008
ChinaActive - Recruiting
Hubei Cancer Hospital
Wuhan, Hubei 430079
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shanxi 710061
ChinaActive - Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310016
ChinaActive - Recruiting
The first affiliated hospital of Ningbo University
Ningbo, Zhejiang 315010
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang 325000
ChinaSite Not Available
Fakultni nemocnice Olomouc
Olomouc, 779 00
CzechiaActive - Recruiting
Vseobecna fakultni nemocnice v Praze
Praha 2, 12808
CzechiaActive - Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
JapanSite Not Available
INCAN
Cdmx, Distrito Federal 14080
MexicoActive - Recruiting
Hospital MAC Periferico Sur
Ciudad de Mexico, Distrito Federal 04700
MexicoActive - Recruiting
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, Distrito Federal
MexicoActive - Recruiting
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo LEÓN 64460
MexicoActive - Recruiting
Hospital Reforma
Oaxaca de Juárez, Oaxaca 68000
MexicoActive - Recruiting
Oaxaca Site Management Organization
Oaxaca, 68000
MexicoActive - Recruiting
Narodny onkologicky ustav
Bratislava, 833 10
SlovakiaActive - Recruiting
Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA
Bratislava, 812 50
SlovakiaActive - Recruiting
Fakultna nemocnica s poliklinikou Nove Zamky
Nove Zamky, 940 34
SlovakiaActive - Recruiting
POKO Poprad, s.r.o.
Poprad, 058 01
SlovakiaActive - Recruiting
Cancer Research UK Edinburgh Centre
Edinburgh, Edinburgh, CITY OF EH4 2XR
United KingdomActive - Recruiting
St Bartholomew's Hospital
London, London, CITY OF EC1A 7BE
United KingdomActive - Recruiting
Sarah Cannon Research Institute UK
London, W1G 6AD
United KingdomActive - Recruiting
The Christie Hospital NHS Foundation Trust
Manchester, M20 4BX
United KingdomActive - Recruiting
Scottsdale Healthcare Hospitals dba HonorHealth
Scottsdale, Arizona 85258
United StatesSite Not Available
Ellison Institute
Los Angeles, California 90064
United StatesSite Not Available
Smilow Cancer Center at Yale New Haven-Hospital
New Haven, Connecticut 06510
United StatesActive - Recruiting
Smilow Cancer Hospital Phase 1 Unit
New Haven, Connecticut 06511
United StatesActive - Recruiting
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut 06510
United StatesActive - Recruiting
Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut 06510
United StatesActive - Recruiting
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesActive - Recruiting
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts 02215
United StatesActive - Recruiting
Dana Farber Cancer Institute- Chestnut Hill
Newton, Massachusetts 02459
United StatesActive - Recruiting
START Midwest
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Tennessee Oncology PLLC
Franklin, Tennessee 37067
United StatesSite Not Available
Tennessee Oncology, PLLC
Franklin, Tennessee 37067
United StatesActive - Recruiting
SCRI Oncology Partners
Nashville, Tennessee 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesActive - Recruiting
Sarah Cannon Research Institute - Pharmacy
Nashville, Tennessee 37203
United StatesActive - Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
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