Breast Cancer Clinical Trial

PF-07104091 as a Single Agent and in Combination Therapy

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 small cell lung, non small cell lung, and ovarian and breast cancers.

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Full Description

Study C4161001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety, pharmacokinetic (PK) and pharmacodynamic study of PF-07104091 in adult patients with advanced or metastatic small cell lung cancer (SCLC), advanced platinum resistant epithelial ovarian cancer/fallopian tube cancer/primary peritoneal cancer, locally recurrent/advanced or metastatic triple negative breast cancer (TNBC), HR-positive HER2-negative advanced or mBC, advanced or metastatic non-small cell lung cancer (NSCLC). This two part study will assess the safety and tolerability of increasing dose levels of PF-07104091 in Part 1, and establish the recommended Phase 2 dose (RP2D) in Part 2.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Participants with HR-positive HER2-negative advanced or metastatic breast cancer (received at least two prior lines in the advanced or metastatic setting including one prior line of combined CDK4/6 inhibitor and endocrine therapy and no more than two prior lines of cytotoxic chemotherapy)
Participants with locally recurrent/advanced or metastatic TNBC who have received up to 2 prior lines of chemotherapy in the advanced or metastatic setting
Participants with advanced platinum resistant epithelial ovarian cancer (EOC)/fallopian tube cancer/primary peritoneal cancer (PPC) (histologically or cytologically proven) who have received at least 1 systemic anti-cancer therapy containing a platinum analog
Participants with cytological diagnosis of advanced/metastatic SCLC
Participants with or cytological diagnosis of advanced/metastatic NSCLC
Participants with HR-positive HER2-negative advanced or metastatic breast cancer (second line plus setting) (histologically or cytologically proven).
Participants entering the study in the expansion cohort have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated
Performance Status 0 or 1
Adequate bone marrow, hematological, kidney and liver function
Resolved acute effects of any prior therapy to baseline severity

Exclusion Criteria:

Participants with known symptomatic brain metastases requiring steroids
Participants with any other active malignancy within 3 years prior to enrollment
Major surgery within 3 weeks prior to study entry
Radiation therapy within 3 weeks prior to study entry.
Systemic anti cancer therapy within 4 weeks prior to study
Prior irradiation to >25% of the bone marrow
Participants with active, uncontrolled bacterial, fungal, or viral infection, including HBV, HCV, and known HIV or AIDS related illness
Active COVID-19/SARS-CoV2 infection
Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Any of the following in the previous 6 months: myocardial infarction, long QT syndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities, unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New York Heart Association class III or IV, cerebrovascular accident, transient ischemic attack, symptomatic pulmonary embolism, and/or other clinical significant episode of thrombo embolic disease.
Anticoagulation with vitamin K antagonists or factor Xa inhibitors is not allowed.
Hypertension that cannot be controlled by medications
Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry.
Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.
Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.
Participants with advanced/metastatic, symptomatic, visceral spread, that are at risk of life threatening complications in the short
Participants with an indwelling catheter that has an external component such as those used for drainage of effusion(s) or central venous catheter that is externally
Previous high dose chemotherapy requiring stem cell rescue
Known abnormalities in coagulation such as bleeding diathesis, or treatment with anticoagulants precluding intramuscular injections of goserelin (if applicable).
Current use or anticipated need for food or drugs that are known strong CYP3A4/5 or UGT1A9 inhibitors or inducers
Current use or anticipated need for drugs that are known sensitive UGT1A1 substrates with narrow therapeutic
Serum pregnancy test positive at screening
Other medical or psychiatric condition

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

154

Study ID:

NCT04553133

Recruitment Status:

Active, not recruiting

Sponsor:

Pfizer

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There are 41 Locations for this study

See Locations Near You

Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Clive Iowa, 50325, United States
Des Moines Oncology Research Association
Des Moines Iowa, 50309, United States
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines Iowa, 50309, United States
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines Iowa, 50314, United States
Norton Cancer Institute Downtown
Louisville Kentucky, 40202, United States
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville Kentucky, 40202, United States
Norton Cancer Institute, Downtown
Louisville Kentucky, 40202, United States
Norton Hospital
Louisville Kentucky, 40202, United States
Norton Cancer Institute, St. Matthews
Louisville Kentucky, 40207, United States
Norton Women's and Children's Hospital (St. Matthews)
Louisville Kentucky, 40207, United States
Norton Cancer Institute, Audubon
Louisville Kentucky, 40217, United States
Norton Hospital (Audubon)
Louisville Kentucky, 40217, United States
Norton Brownsboro Hospital
Louisville Kentucky, 40241, United States
Norton Cancer Institute, Brownsboro Campus
Louisville Kentucky, 40241, United States
Norton Diagnostic Center - Fern Creek
Louisville Kentucky, 40291, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
Dana-Farber Cancer Institute - Chestnut Hill
Newton Massachusetts, 02459, United States
START Midwest
Grand Rapids Michigan, 49546, United States
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City New York, 11101, United States
NYU Langone Hospital - Long Island
Mineola New York, 11501, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola New York, 11501, United States
Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York New York, 10016, United States
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York New York, 10016, United States
NYU Langone Medical Center (Tisch Hospital)
New York New York, 10016, United States
MSK Rockefeller Outpatient Pavilion
New York New York, 10022, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
White Plains Hospital
White Plains New York, 10601, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22903, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
UVA Breast Care Center
Charlottesville Virginia, 22911, United States
Centro Oncologico Korben
Caba Buenos Aires, C1426, Argentina
Fundación Cenit Para La Investigación En Neurociencias
Caba Ciudad Autónoma DE Buenos Aires, 1125, Argentina
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan , 5400, Argentina
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo , 6300, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv , 4004, Bulgaria
Complex Oncology Center - Shumen
Shumen , 9700, Bulgaria
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Jilin Province Cancer Hospital
Changchun Jilin, 13000, China
The First Hospital of Jilin University
Changchun Jilin, 13002, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20003, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin Tianjin, 30006, China
Henan Cancer Hospital
Zhengzhou , 45000, China
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
The Cancer Institute Hospital of JFCR
Koto Tokyo, 135-8, Japan
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City Distrito Federal, 04700, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey Nuevo LEÓN, 64460, Mexico
Oaxaca Site Management Organization
Oaxaca , 68000, Mexico

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

154

Study ID:

NCT04553133

Recruitment Status:

Active, not recruiting

Sponsor:


Pfizer

How clear is this clinincal trial information?

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