Phase
Condition
Small Cell Lung Cancer
Breast Cancer
Ovarian Cancer
Treatment
PF-07104091 monotherapy dose expansion (SCLC)
PF-07104091 + palbociclib + fulvestrant
PF-07104091 monotherapy dose escalation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 includingone prior line of combined CDK4/6 inhibitor and endocrine therapy and no more thantwo prior lines of cytotoxic chemotherapy)
Participants with locally recurrent/advanced or metastatic TNBC who have received upto 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 orcytologically proven) who have received at least 1 systemic anti-cancer therapycontaining 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 measurablelesion 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
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 mayaffect participant safety or interpretation of study results
Any of the following in the previous 6 months: myocardial infarction, long QTsyndrome, Torsade de Pointes, arrhythmias, serious conduction system abnormalities,unstable angina, coronary/peripheral artery bypass graft, symptomatic CHF, New YorkHeart Association class III or IV, cerebrovascular accident, transient ischemicattack, symptomatic pulmonary embolism, and/or other clinical significant episode ofthrombo 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 weeksprior to study entry.
Known or suspected hypersensitivity to active ingredient/excipients in PF 07104091.
Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticulardisease or previous gastric resection or lap band surgery.
Participants with advanced/metastatic, symptomatic, visceral spread, that are atrisk of life threatening complications in the short
Participants with an indwelling catheter that has an external component such asthose 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 withanticoagulants precluding intramuscular injections of goserelin (if applicable).
Current use or anticipated need for food or drugs that are known strong CYP3A4/5 orUGT1A9 inhibitors or inducers
Current use or anticipated need for drugs that are known sensitive UGT1A1 substrateswith narrow therapeutic
Serum pregnancy test positive at screening
Other medical or psychiatric condition
Study Design
Study Description
Connect with a study center
Centro Oncologico Korben
Caba, Buenos Aires C1426AGE
ArgentinaSite Not Available
Fundación Cenit Para La Investigación En Neurociencias
Caba, Ciudad Autónoma DE Buenos Aires 1125
ArgentinaSite Not Available
Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan
San Juan, 5400
ArgentinaSite Not Available
Specialized Hospital for Active Treatment of Oncology - Haskovo
Haskovo, 6300
BulgariaSite Not Available
Complex Oncology Center - Plovdiv EOOD
Plovdiv, 4004
BulgariaSite Not Available
Complex Oncology Center - Shumen
Shumen, 9700
BulgariaSite Not Available
Henan Cancer Hospital
Zhengzhou, Henan 450008
ChinaSite Not Available
Jilin Province Cancer Hospital
Changchun, Jilin 130000
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
ChinaSite Not Available
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin 300060
ChinaSite Not Available
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
JapanSite Not Available
The Cancer Institute Hospital of JFCR
Koto, Tokyo 135-8550
JapanSite Not Available
COI Centro Oncologico Internacional S.A.P.I. de C.V.
Mexico City, Distrito Federal 04700
MexicoSite Not Available
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo LEÓN 64460
MexicoSite Not Available
Oaxaca Site Management Organization
Oaxaca, 68000
MexicoSite Not Available
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Clive, Iowa 50325
United StatesSite Not Available
Des Moines Oncology Research Association
Des Moines, Iowa 50309
United StatesSite Not Available
Medical Oncology & Hematology Associates DBA Mission Cancer and Blood
Des Moines, Iowa 50309
United StatesSite Not Available
Norton Brownsboro Hospital
Louisville, Kentucky 40241
United StatesSite Not Available
Norton Cancer Institute Downtown
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Cancer Institute Pharmacy, Downtown Pharmacy
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Cancer Institute, Audubon
Louisville, Kentucky 40217
United StatesSite Not Available
Norton Cancer Institute, Brownsboro Campus
Louisville, Kentucky 40241
United StatesSite Not Available
Norton Cancer Institute, Downtown
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Cancer Institute, St. Matthews
Louisville, Kentucky 40207
United StatesSite Not Available
Norton Diagnostic Center - Fern Creek
Louisville, Kentucky 40291
United StatesSite Not Available
Norton Hospital
Louisville, Kentucky 40202
United StatesSite Not Available
Norton Hospital (Audubon)
Louisville, Kentucky 40217
United StatesSite Not Available
Norton Women's and Children's Hospital (St. Matthews)
Louisville, Kentucky 40207
United StatesSite Not Available
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
Dana-Farber Cancer Institute - Chestnut Hill
Newton, Massachusetts 02459
United StatesSite Not Available
START Midwest
Grand Rapids, Michigan 49546
United StatesSite Not Available
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United StatesSite Not Available
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center (IDS Pharmacy)
Long Island City, New York 11101
United StatesSite Not Available
NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesSite Not Available
Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Mineola, New York 11501
United StatesSite Not Available
Laura & Isaac Perlmutter Cancer Center - NYU ACC
New York, New York 10016
United StatesSite Not Available
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York 10016
United StatesSite Not Available
MSK Rockefeller Outpatient Pavilion
New York, New York 10022
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
NYU Langone Medical Center (Tisch Hospital)
New York, New York 10016
United StatesSite Not Available
White Plains Hospital
White Plains, New York 10601
United StatesSite Not Available
Tennessee Oncology PLLC
Franklin, Tennessee 37067
United StatesSite Not Available
The Sarah Cannon Research Institute
Nashville, Tennessee 37203
United StatesSite Not Available
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
UVA Breast Care Center
Charlottesville, Virginia 22911
United StatesSite Not Available
University of Virginia Cancer Center
Charlottesville, Virginia 22903
United StatesSite Not Available
University of Virginia Health System
Charlottesville, Virginia 22908
United StatesSite Not Available
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