Spots Global Cancer Trial Database for Study of PF-07248144 in Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: Study of PF-07248144 in Advanced or Metastatic Solid Tumors
Official Title: A Phase 1 Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Anti-tumor Activity of PF-07248144 in Participants With Advanced or Metastatic Solid Tumors.
Study ID: NCT04606446
Study Description
Brief Summary: This is an open-label, multi center study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-07248144 and early signs of clinical efficacy of PF-07248144 as a single agent and in combination with either fulvestrant or letrozole + palbociclib or with PF-07220060 + fulvestrant
Detailed Description: Study has two parts, Part 1 (dose escalation) and Part 2 (dose expansion). Part 1 is divided into Parts 1A, 1B, 1C and 1D and Part 2 is divided into Parts 2A, 2B and 2D. In Part 1A, single escalating doses of PF-07248144 alone will be administered to determine the maximum tolerable dose (MTD) and select the recommended dose for expansion (RDE). In Part 1B,1C and 1D, PF-07248144 will be administered in combination with either fulvestrant (Part 1B); palbociclib + letrozole (Part 1C) or PF-07220060+fulvestrant (Part 1D).. After the determination of the monotherapy RDE in Part 1A, PF-07248144 will be evaluated in a dose expansion cohort as a monotherapy in Part 2A. After determination of the combination RDE from Part 1B, PF-07248144 in combination with fulvestrant, PF-07248144 will be evaluated in a combination dose expansion with fulvestrant in Part 2B. In Part 1C, PF-07248144 in combination with letrozole + palbociclib will be evaluated for dose finding to determine the MTD and RDE for this combination. After determination of the triple combination RDE from Part 1D, PF-07248144 in combination with PF-07220060 + fulvestrant will be evaluated in a combination dose-expansion cohort, Part 2D.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
HonorHealth, Scottsdale, Arizona, United States
Cedars Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States
Cedars-Sinai Medical Center; SOCCI Pharmacy, Los Angeles, California, United States
UCSF Medical Center at Mission Bay, San Francisco, California, United States
Smilow Cancer Hospital at Yale - New Haven, New Haven, Connecticut, United States
Yale-New Haven Hospital- Yale Cancer Center, New Haven, Connecticut, United States
Yale-New Haven Hospital, New Haven, Connecticut, United States
Smilow Cancer Hospital Phase 1 Unit, New Haven, Connecticut, United States
Yale New Haven Hospital, New Haven, Connecticut, United States
Yale University - Yale Cancer Center, New Haven, Connecticut, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
St. Elizabeth Healthcare, Edgewood, Kentucky, United States
James Graham Brown Cancer Center, Louisville, Kentucky, United States
University Medical Center, lnc.:DBA University of Louisville Hospital, Louisville, Kentucky, United States
Michigan Health Professionals, Farmington Hills, Michigan, United States
Revive Research Institute, Farmington Hills, Michigan, United States
Thomas Jefferson University, Bodine Center for Radiation Therapy, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Clinical Research Unit, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Gibbon Building, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Investigational Drug Service, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Main Office Building, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Research Organization, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
TJU Research PK/PD Lab, Philadelphia, Pennsylvania, United States
Tennessee Oncology PLLC, Franklin, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
The Sarah Cannon Research Institute / Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The University of Texas M. D. Anderson Cancer Center, Houston, Texas, United States
U.T. MD Anderson Cancer Center, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
Swedish Medical Center, Seattle, Washington, United States
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
Cancer Research South Australia, Adelaide, South Australia, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Royal Melbourne Hospital, Parkville, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals, St Albans, Victoria, Australia
St. John of God Subiaco Hospital, Subiaco, Western Australia, Australia
Beijing Cancer hospital, Beijing, Beijing, China
SUN Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Hubei Cancer Hospital, Wuhan, Hubei, China
Jilin Cancer Hospital, Changchun, Jilin, China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Kanagawa cancer center, Yokohama, Kanagawa, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Seoul National University Bundang Hospital, Seongnam, Ky?nggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, Taegu-kwangyǒkshi, Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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