*Metastatic Castrate Resistant Prostate Cancer (mCRPC)
Conditions
Interventions
*Drug: PF-06821497
-875 mg BID (2 times a day)
-Other Names:
#EZH2i
*Drug: Docetaxel
-75 mg/m2 IV (every 21 days)
-Other Names:
#Taxotere
*Drug: Enzalutamide
-160 mg QD
-Other Names:
#XTANDI
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion Criteria: *Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. *Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan. *Surgically or medically castrated, with serum testosterone <=50 ng/dL (<=1.73 nmol/L) at screening. *Progressive disease in the setting of surgical or medical castration. Note: Evidence of disease progression with at least 12 weeks of abiraterone acetate in the metastatic castrate sensitive prostate cancer (mCSPC) setting, or first line metastatic castrate resistant prostate cancer (mCRPC) setting is required. *Eastern Cooperate Oncology Group (ECOG) performance status 0 - 2, with life expectancy of at least 6 months as assessed by the investigator.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: *Any medical (including active or clinically significant bacterial, fungal or viral infection) or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. *Know history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery. *Clinically significant cardiovascular disease. *Central nervous system (CNS) pathology/neurological findings including known or suspected brain metastasis or active leptomeningeal disease, symptomatic or impending spinal cord compression or cauda equina syndrome, or clinically significant history of seizure or any condition that may predispose to seizure. *Prior treatment for prostate cancer at any stage with any cytotoxic chemotherapy, radioligand therapy, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment (approved drugs or experimental compounds such as, antibody therapy, immunotherapy, gene therapy, angiogenesis inhibitors, EZH2 inhibitors), with the following exceptions: 1. Treatment with first-generation antiandrogen agents, if discontinued prior to first dose of study intervention. 2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion. * Previous administration with an investigational product within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer). *Inadequate renal function defined by an estimated glomerular filtration rate (eGFR) <45 mL/min. *Hepatic dysfunction. *Hematologic abnormalities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Radiographic Progression Free Survival (rPFS) assessed by blinded independent central review (BICR) per RECIST v1.1 and Prostate Cancer Clinical Trials Working Group 3 (PCWG3) [Time Frame: Randomization up to approximately 2 years.] -rPFS is defined as the time from the date of randomization to first objective evidence of radiographic progression as assessed in soft tissue per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or in bone per Prostate Cancer Clinical Trials Working Group 3 (PCWG3) guidelines by BICR, or death, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Overall survival(OS) [Time Frame:Randomization up to approximately 4.5 years] -OS is defined as the time from the date of randomization to the date of death due to any cause *Objective Response(ORR) [Time Frame:Randomization up to approximately 4.5 years] -The objective response rate is defined as the proportion of participants with measurable soft tissue disease at baseline who have a confirmed objective response of complete response (CR) or partial response (PR) per RECIST v1.1. *Duration of Response(DoR) in measurable soft tissue disease [Time Frame:Randomization up to approximately 4.5 years] -The DoR is defined as the first objective evidence of soft tissue response (CR or PR, whichever is earlier) to radiographic progression or death due to any cause whichever occurs first *Time to prostate specific antigen(PSA) progression. [Time Frame:Randomization up to approximately 4.5 years] -Proportion of participants with PSA response >=50% in participants with detectable PSA values at baseline *Time to initiation of antineoplastic therapy. [Time Frame:Randomization up to approximately 4.5 years] -Time from randomization to first use of new antineoplastic therapy *Prostate Specific Antigen Response [Time Frame:Randomization up to approximately 4.5 years] -Proportion of participants with PSA response >=50% in participants with detectable PSA values at baseline *Incidence of Adverse Events [Time Frame:Randomization up to approximately 4.5 years] -Type, incidence, severity [as graded by National Cancer Institute(NCI) common terminology criteria for adverse events(CTCAE) v5.0], seriousness and relationship to study medications of AEs *Time to first symptomatic skeletal event [Time Frame:Randomization up to approximately 4.5 years] -Time from randomization to first symptomatic skeletal event(symptomatic bone fractures, spinal cord compression, surgery or radiation to the bone whichever is first) *Change from baseline in patient reported pain symptoms per Brief Pain Invento | — |
Countries
Argentina, Australia, Brazil, Canada, China, Czechia, France, Germany, Greece, Hungary, Italy, Japan, Netherlands, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed