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ACTIVE NOT RECRUITING
NCT04553133
PHASE2

PF-07104091 as a Single Agent and in Combination Therapy

Sponsor: Pfizer

View on ClinicalTrials.gov

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

DRUG

PF-07104091 monotherapy dose escalation

PF-07104091 will be administered orally

DRUG

PF-07104091 + palbociclib + fulvestrant

PF-07104091 will be administered orally in combination with palbociclib and fulvestrant

DRUG

PF-07104091 + palbociclib + letrozole

PF-07104091 will be administered orally in combination with palbociclib and letrozole

DRUG

PF-07104091 monotherapy dose expansion (ovarian)

PF-07104091 will be administered orally

DRUG

PF-07104091 monotherapy dose expansion (SCLC)

PF-07104091 will be administered orally

DRUG

PF-07104091 + Fulvestrant (post CDK4/6)

PF-07104091 will be administered orally in combination with fulvestrant

DRUG

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