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PF-07104091 as a Single Agent and in Combination Therapy
Sponsor: Pfizer
Summary
To assess the safety and tolerability of increasing doses of PF-07104091 and to estimate the Maximum Tolerated Dose (MTD) and/or select the Recommended Phase 2 dose (RP2D) for PF-07104091 as a single agent in participants with advanced or metastatic small cell lung, breast and ovarian cancers.
Official title: PHASE 1/2A DOSE ESCALATION, FINDING AND EXPANSION STUDY EVALUATING SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07104091 AS A SINGLE AGENT AND IN COMBINATION THERAPY
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2020-09-16
Completion Date
2026-03-30
Last Updated
2026-04-02
Healthy Volunteers
No
Interventions
PF-07104091 monotherapy dose escalation
PF-07104091 will be administered orally
PF-07104091 + palbociclib + fulvestrant
PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
PF-07104091 + palbociclib + letrozole
PF-07104091 will be administered orally in combination with palbociclib and letrozole
PF-07104091 monotherapy dose expansion (ovarian)
PF-07104091 will be administered orally
PF-07104091 monotherapy dose expansion (SCLC)
PF-07104091 will be administered orally
PF-07104091 + Fulvestrant (post CDK4/6)
PF-07104091 will be administered orally in combination with fulvestrant
PF-0704091 + Fulvestrant (post CDK4/6)
PF-07104091 + fulvestrant (post 4/6) dose expansion
Locations (46)
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Clive, Iowa, United States
Des Moines Oncology Research Association
Des Moines, Iowa, United States
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines, Iowa, United States
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines, Iowa, United States
Norton Cancer Institute Downtown
Louisville, Kentucky, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky, United States
Norton Cancer Institute, Downtown
Louisville, Kentucky, United States
Norton Hospital
Louisville, Kentucky, United States
Norton Cancer Institute, St. Matthews Campus
Louisville, Kentucky, United States
Norton Women's and Children's Hospital (St. Matthews)
Louisville, Kentucky, United States
Norton Cancer Institute, Audubon
Louisville, Kentucky, United States
Norton Hospital (Audubon)
Louisville, Kentucky, United States
Norton Brownsboro Hospital
Louisville, Kentucky, United States
Norton Cancer Institute, Brownsboro Campus
Louisville, Kentucky, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham & Women's Hospital
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
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City, New York, United States
NYU Langone Hospital - Long Island
Mineola, New York, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York, United States
Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York, New York, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States
NYU Langone Medical Center (Tisch Hospital)
New York, New York, United States
MSK Rockefeller Outpatient Pavilion
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
White Plains Hospital
White Plains, New York, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
University of Virginia Cancer Center
Charlottesville, Virginia, United States
University of Virginia Health System
Charlottesville, Virginia, United States
UVA Breast Care Center
Charlottesville, Virginia, United States
Centro Oncologico Korben
Caba, Buenos Aires, Argentina
Fundación Cenit Para La Investigación En Neurociencias
CABA, Buenos Aires F.D., Argentina
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, Argentina
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, Bulgaria
Complex Oncology Center - Shumen
Shumen, Bulgaria
Jilin Province Cancer Hospital
Changchun, Jilin, China
The First Hospital of Jilin University
Changchun, Jilin, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
The Cancer Institute Hospital of JFCR
Koto, Tokyo, Japan