Spots Global Cancer Trial Database for Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
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Trial Identification
Brief Title: Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
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
Study ID: NCT04557449
Study Description
Brief Summary: This is a Phase 1/2A, open label, multicenter, nonrandomized, multiple dose, safety, tolerability, pharmacokinetic and pharmacodynamic study of PF-07220060 administered as a single agent and then in combination with endocrine therapy.
Detailed Description: The study consists of two parts and a China and Japan monotherapy cohort. Part 1 includes dose escalation cohorts evaluating PF-07220060 as single agent or in combination with endocrine therapy or enzalutamide, as well as a food effect cohort and a DDI cohort Part 2 includes dose expansion cohorts evaluating PF-07220060 in combination with endocrine therapy or enzalutamide. In Part 1A, single escalating doses of PF-07220060 alone will be administered to determine the maximum tolerated dose (MTD) and select the recommended dose for expansion In Part 1B and Part 1C, PF-07220060 will be administered in combination with 1 of 2 endocrine therapies (letrozole and fulvestrant, respectively). In Part 1D, food effect assessment of PF-07220060 at the RP2D dose level from the Part 1A will be conducted In Part 1E, the effect of PF-07220060 on the PK of midazolam will be evaluated (DDI) In Part 1F, escalating dosed of PF-07220060 will be administered in combination with enzalutamide Part 1B and Part 1C may commence at MTD or before reaching the MTD at a dose level in Part 1A. Part 2A is a dose expansion cohort with fulvestrant and will explore more than one dose of PF-07220060 in participants diagnosed with mBC. Part 2B and Part 2C are expansion for combination therapy of PF-07220060 with letrozole and fulvestrant, respectively. Part 2D is the expansion cohort for combination therapy of PF-07220060 with enzalutamide. The China monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as single agent in Chinese participants. The Japan monotherapy cohort will evaluate safety, tolerability and PK of PF-07220060 administered as a single agent in Japanese participants.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Smilow Cancer Hospital at Yale - New Haven, New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit, New Haven, Connecticut, United States
Brigham & Women's Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute (DFCI), Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Dana Farber Cancer Institute- Chestnut Hill, Newton, Massachusetts, United States
START Midwest, Grand Rapids, Michigan, United States
Tennessee Oncology, PLLC, Franklin, Tennessee, United States
Sarah Cannon Research Institute - Pharmacy, Nashville, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Hospital Brit谩nico de Buenos Aires, Ciudad aut贸noma de Buenos Aires, Buenos Aires, Argentina
Fundaci贸n Cenit Para La Investigaci贸n En Neurociencias, Caba, Ciudad Aut茫鲁noma DE Buenos Aires, Argentina
Fundaci贸n Respirar, Buenos Aires, , Argentina
Cl铆nica Universitaria Reina Fabiola, C贸rdoba, , Argentina
Fundaci贸n CORI para la Investigaci贸n y Prevenci贸n del C谩ncer, La Rioja, , Argentina
Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Hubei Cancer Hospital, Wuhan, Hubei, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shanxi, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The first affiliated hospital of Ningbo University, Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
INCAN, Cdmx, Distrito Federal, Mexico
Hospital MAC Periferico Sur, Ciudad de Mexico, Distrito Federal, Mexico
COI Centro Oncologico Internacional S.A.P.I. de C.V., Mexico City, Distrito Federal, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Monterrey, Nuevo LE脫N, Mexico
Hospital Reforma, Oaxaca de Ju谩rez, Oaxaca, Mexico
Oaxaca Site Management Organization, Oaxaca, , Mexico
Onkologicky ustav sv. Alzbety, s.r.o., Interna klinika VSZaSP a OUSA, Bratislava, , Slovakia
Narodny onkologicky ustav, Bratislava, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky, Nove Zamky, , Slovakia
POKO Poprad, s.r.o., Poprad, , Slovakia
Cancer Research UK Edinburgh Centre, Edinburgh, Edinburgh, CITY OF, United Kingdom
St Bartholomew's Hospital, London, London, CITY OF, United Kingdom
Sarah Cannon Research Institute UK, London, , United Kingdom
The Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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