Last updated 33 days ago
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors
337 patients around the world
Available in Argentina, Mexico, United States
Pfizer
10Research sites
337Patients around the world
This study is for people with
Prostate cancer
Metastatic prostate cancer
Breast Cancer
Liposarcoma
Dedifferentiated Liposarcoma
Solid tumors
Lung cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Part 1: Breast Cancer (BC) Refractory Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) BC.Part 1A/Part 1D/Part1E also include: Refractory HR-positive/HER2-positive BC.Part 1: Tumors other than BC (Part 1A/Part 1D/Part 1E): NSCLC, prostate, CRC, liposarcoma, or tumors with previously confirmed CDK4 or CCND1 amplification according to local standard tests.Part 1F: Prostate cancer.Part 2A, 2B and 2C: HR-positive/HER2-negative BC.Patients who are either postmenopausal women or pre/peri-menopausal (Part 2C only).Part 1D: Metastatic castration resistant prostate cancer.Lesion: Part 1: Evaluable lesion (including skin or bone lesion only).Part 2A, 2B and 2C: Measurable lesion per RECIST v1.1.Part 2D: Participants with evaluable disease as per PCWG3; participants with bone metastases only are allowed. Participants with biochemical recurrence only are excluded.Prior systemic Treatment: Part 1: HR-positive/HER2-negative BC:At least 1 line of SOC, including CD4/6 inhibitor therapy for advanced or metastatic disease, or if CDK4/6 inhibitors are not considered appropriate in the opinion of the investigator.At least 1 line of anti-endocrine in countries without CDK4/6 inhibitor approval or reimbursement, for advanced or metastatic disease.HR-positive/HER2-positive BC (Parts 1A/1D/1E): at least 1 prior treatment of approved HER2 targeting therapy.Tumors other than BC (Parts 1A/1D/1E/1F): tumor that is resistant to at least 2 lines of SOC for advanced or recurrent disease or for which no standard therapy is available.Part 2A: Participants must have received at least 1 line of standard of care (including prior CDK4/6i) for advanced/metastatic disease; Prior chemo is allowed; Prior fulvestrant, mTOR and/or PI3K inhibitors are allowed.Part 2B: Participants who have not received any prior systemic anti-cancer therapies for advanced/metastatic BC.Part 2C:Progressed during treatment or within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre or perimenopausal, or.Progressed while on or within 1 month after the endo the prior aromatase inhibitor therapy for advanced/metastatic BC if postmenopausal or prior endocrine treatment for advanced/metastatic BC if pre or perimenopausal.One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.Part 2D:Received prior abiraterone; enzalutamide and CDK4i naive.0-1 line of chemotherapy is allowedGeneral Inclusion Criteria.All participants must be refractory to or intolerant of existing therapies known to provide clinical benefit for their condition.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.Adequate renal, liver, and bone marrow function.
- Part 1D: Participants who have had a gastrectomy or have dietary or other restrictions that preclude a 10 hour overnight fast or consumption of the high fat, high calorie meal.Part 2B: Prior neoadjuvant or adjuvant treatment with a non-steroidal aromatase inhibitor with disease recurrence while on or within 12 months of completing treatment. Prior treatment with any CDK4/6 inhibitor.Part 2C: Prior treatment with any CDK inhibitor, fulvestrant, everolimus, or any agent whose mechanism of action is to inhibit the PI3K-mTOR pathway.Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases carcinomatous meningitis, or leptomeningeal disease.Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.Major surgery or radiation within 4 weeks prior to study intervention.Last anti-cancer treatment within 2 weeks prior to study intervention.Participation in other studies involving investigational drug(s) within 4 weeks prior to study entry.Pregnant or breastfeeding female participant.Active inflammatory gastrointestinal (GI) disease, known diverticular disease or previous gastric resection or lap band surgery including impairment of gastrointestinal function or GI disease.
Sites
Centro de Investigaciones Clínicas - Clínica Viedma - Río Negro
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Fundación Respirar
Recruiting
Incan - Instituto Do Cancer - Hospital Pompeia
Universidad Autónoma de Nuevo León, Hospital Universitario Dr. José Eleuterio González
Recruiting
Oaxaca Site Management Organization S.C.
Recruiting
Hospital MAC - Periférico Sur
Recruiting
COI Centro Oncológico Internacional S.A.P.I
Recruiting
Hospital Reforma
Recruiting
StudyCDK4i
SponsorPfizer
Study typeInterventional
Conditions
Metastatic prostate cancerBreast CancerDedifferentiated LiposarcomaSolid tumorsLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT04557449
