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Clinical Trials in the USA / NCT04553133
Active, not recruiting Phase 2

PF-07104091 as a Single Agent and in Combination Therapy

NCT04553133 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 2
Started
2020-09-16
Last updated
2026-05-06

Condition(s) studied

Small Cell Lung CancerOvarian CancerBreast Cancer

Investigational drug(s) / intervention(s)

PF-07104091 monotherapy dose escalationPF-07104091 + palbociclib + fulvestrantPF-07104091 + palbociclib + letrozolePF-07104091 monotherapy dose expansion (ovarian)PF-07104091 monotherapy dose expansion (SCLC)PF-07104091 + Fulvestrant (post CDK4/6)PF-0704091 + Fulvestrant (post CDK4/6)

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (22)

FacilityCityRegionStatus
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood Clive Iowa
Des Moines Oncology Research Association Des Moines Iowa
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood Des Moines Iowa
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood Des Moines Iowa
Norton Hospital Louisville Kentucky
Norton Cancer Institute, St. Matthews Campus Louisville Kentucky
Norton Cancer Institute, Audubon Louisville Kentucky
Norton Brownsboro Hospital Louisville Kentucky
Norton Cancer Institute, Brownsboro Campus Louisville Kentucky
Massachusetts General Hospital Boston Massachusetts
Dana-Farber Cancer Institute - Chestnut Hill Newton Massachusetts
Memorial Sloan Kettering Monmouth Middletown New Jersey
Memorial Sloan Kettering Cancer Center (IDS Pharmacy) Long Island City New York
Laura & Isaac Perlmutter Cancer Center - NYU ACC New York New York
NYU Langone Medical Center (Tisch Hospital) New York New York
White Plains Hospital White Plains New York
UVA Breast Care Center Charlottesville Virginia
Centro de Investigaciones Medicas y Desarrollo LC Buenos Aires Buenos Aires F.D.
Complex Oncology Center - Plovdiv EOOD Plovdiv Bulgaria
Complex Oncology Center - Shumen Shumen Bulgaria
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin Municipality

More Pfizer trials in the USA

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04553133 on ClinicalTrials.gov ↗ ← All trials in the USA