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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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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