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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04553133
Other study ID # C4161001
Secondary ID 2022-001679-15
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 16, 2020
Est. completion date January 7, 2026

Study information

Verified date March 2023
Source Pfizer
Contact Pfizer CT.gov Call Center
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 320
Est. completion date January 7, 2026
Est. primary completion date January 7, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
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

Country Name City State
China Fudan University Shanghai Cancer Center Shanghai Shanghai
China Tianjin Medical University Cancer Institute & Hospital Tianjin Tianjin
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan The Cancer Institute Hospital of JFCR Koto Tokyo
Mexico COI Centro Oncologico Internacional S.A.P.I. de C.V. Mexico City Distrito Federal
Mexico Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo LEÓN
Mexico Oaxaca Site Management Organization Oaxaca
United States Brigham & Women's Hospital Boston Massachusetts
United States Dana Farber Cancer Institute Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
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 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 START Midwest Grand Rapids Michigan
United States Memorial Sloan Kettering Westchester Harrison New York
United States University of Texas MD Anderson Cancer Center Houston Texas
United States Norton Brownsboro Hospital Louisville Kentucky
United States Norton Cancer Institute Downtown Louisville Kentucky
United States Norton Cancer Institute Pharmacy, Downtown Pharmacy Louisville Kentucky
United States Norton Cancer Institute, Audubon Louisville Kentucky
United States Norton Cancer Institute, Brownsboro Campus Louisville Kentucky
United States Norton Cancer Institute, Downtown Louisville Kentucky
United States Norton Cancer Institute, St. Matthews Louisville Kentucky
United States Norton Diagnostic Center - Fern Creek Louisville Kentucky
United States Norton Hospital Louisville Kentucky
United States Norton Hospital (Audubon) Louisville Kentucky
United States Norton Women's and Children's Hospital (St. Matthews) Louisville Kentucky
United States Memorial Sloan Kettering Monmouth Middletown New Jersey
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 Memorial Sloan Kettering Cancer Center New York New York
United States MSK Rockefeller Outpatient Pavilion New York New York
United States NYU Langone Medical Center (Tisch Hospital) New York New York
United States White Plains Hospital White Plains New York

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  China,  Japan,  Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose Escalation: Number of participants with Dose-limiting toxicities (DLT) during first cycle Number of participants with DLTs, which are typically Grade 3 or higher adverse events will be summarized by dose level 28 days
Primary To evaluate incidence of treatment emergent adverse events and laboratory abnormalities Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities will be summarized by dose level From baseline until end of study treatment or study completion (approximately 2 years)
Primary Evaluate pulse rate that is out of normal range and changes in pulse rate as compared to baseline Identify pulse rate readings that are outside the normal range. The number and percentage of participants who experienced significant pulse rate change from baseline will be summarized by dose level From baseline until end of study treatment or study completion (approximately 2 years)
Primary Evaluate blood pressure that is out of normal range and changes in blood pressure as compared to baseline Identify systolic and diastolic readings that are outside the normal range. The number and percentage of participants who experienced significant blood pressure change from baseline will be summarized by dose level From baseline until end of study treatment or study completion (approximately 2 years)
Primary To evaluate heart rate corrected QT interval and changes in corrected QT interval as compared to baseline Determine the effect of the drug on QT prolongation. The number and percentage of participants who experienced QT interval prolongation will be summarized by dose level From baseline until end of study treatment or study completion (approximately 2 years)
Primary To evaluate the preliminary antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose expansion Percentage of participants with a best overall response of complete response (CR) or partial response (PR) using RECIST 1.1 From baseline through disease progression or study completion (approximately 2 years)
Secondary Maximum plasma concentration (Cmax) of PF-07104091 after a single dose and multiple dose Peak concentration of PF-07104091 during selected cycles Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Secondary Time to maximum plasma concentration (Tmax) of PF-07104091 after a single dose and multiple dose Time to peak concentration of PF-07104091 during selected cycles Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Secondary Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-07104091 AUC of PF-07104091 will be calculated at selected cycles Day 1 and Day 15 of Cycle 1 (each cycle is 28 days)
Secondary Area under the curve of PF-07104091 with or without food AUC of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food From baseline through time to event on study or study completion (approximately 2 years)
Secondary Maximum plasma concentration of PF-07104091 with or without food Peak concentrations of PF-07104091 in plasma and whether absorption of the drug is affected when taken by food From baseline through time to event on study or study completion (approximately 2 years)
Secondary To document any preliminary evidence of antitumor activity of PF-07104091 as a single agent and in combination with palbociclib and in combination with letrozole or fulvestrant or fulvestrant alone by objective response rate (ORR) in dose escalation Percentage of participants with a best overall response of CR or PR using RECIST 1.1 From baseline and every 8 weeks through disease progression or study completion (approximately 2 years)
Secondary To document any preliminary evidence of antitumor activity of PF-07104091 by time to event endpoints Time from first assessment of event endpoint to last assessment of using RECIST 1.1 From baseline through time to event on study or study completion (approximately 2 years)
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