A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer.
Launched by PFIZER · Sep 27, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new drug called PF-06821497 (also known as Mevrometostat) to see if it works better when combined with another medication called enzalutamide for men with metastatic castration-resistant prostate cancer (mCRPC). This type of cancer has spread beyond the prostate and does not respond to hormone therapy that lowers testosterone levels. The researchers want to find out if the combination of these two drugs can help patients more than enzalutamide alone, especially for those who haven't received other specific treatments yet.
To participate in this study, men must be at least 18 years old, have a confirmed diagnosis of prostate cancer that has spread, and be receiving hormone therapy to keep testosterone levels low. They should also have progressive disease while on this hormone treatment. However, certain health conditions, recent surgeries, or previous treatments may make someone ineligible. If you join this study, you will receive regular check-ups and monitoring to see how the treatment affects your cancer and overall health. This trial is currently recruiting participants, so if you or someone you know is interested, it's a good opportunity to discuss with a healthcare provider.
Gender
MALE
Eligibility 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.
- • Progressive disease in the setting of medical or surgical castration.
- • ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.
- Exclusion Criteria:
- • Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that make the participant inappropriate for the study.
- • Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
- • Clinically significant cardiovascular disease.
- • Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
- • Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
- * Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:
- • 1. Treatment with first-generation antiandrogen (ADT) agents;
- • 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 (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
- • Inadequate organ function.
About Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Edmonton, Alberta, Canada
Seattle, Washington, United States
Madrid, , Spain
Sapporo, Hokkaido, Japan
Seattle, Washington, United States
Seattle, Washington, United States
Glendale, Arizona, United States
Kashiwa, Chiba, Japan
Sapporo, Hokkaido, Japan
Glasgow, , United Kingdom
Taipei, , Taiwan
Milano, , Italy
Yamagata, , Japan
Taichung, , Taiwan
Tainan, , Taiwan
Hamburg, , Germany
Kaohsiung, , Taiwan
Kobe, Hyogo, Japan
Suita, Osaka, Japan
Patras, , Greece
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Martin, , Slovakia
Prague, , Czechia
Kanazawa, Ishikawa, Japan
Yokohama, Kanagawa, Japan
Yokosuka, Kanagawa, Japan
Halifax, Nova Scotia, Canada
Seoul, , Korea, Republic Of
Jinan, Shandong, China
Shanghai, Shanghai, China
Nijmegen, Gelderland, Netherlands
Matsuyama, Ehime, Japan
Helsinki, , Finland
Brest, , France
Porto Alegre, Rio Grande Do Sul, Brazil
Goyang Si, , Korea, Republic Of
Fukuoka, , Japan
Xi'an, Shaanxi, China
Taipei, , Taiwan
Beijing, Beijing, China
Ostrava, , Czechia
Pierre Bénite, , France
Changsha, Hunan, China
Zhengzhou, Henan, China
Stockholm, , Sweden
Suzhou, Jiangsu, China
Christchurch, Canterbury, New Zealand
Porto Alegre, Rio Grande Do Sul, Brazil
Chandler, Arizona, United States
Springdale, Arkansas, United States
Myrtle Beach, South Carolina, United States
Wuhan, Hubei, China
Valencia, , Spain
Næstved, , Denmark
Hohhot, Inner Mongolia, China
Quincy, Illinois, United States
Shinjuku Ku, Tokyo, Japan
Osaka, , Japan
Wenzhou, Zhejiang, China
Daegu, , Korea, Republic Of
Xinxiang, Henan, China
Kumamoto, , Japan
Guangzhou, Guangdong, China
Nanjing, Jiangsu, China
Roma, Lazio, Italy
Olomouc, , Czechia
Cremona, , Italy
Qingdao, Shandong, China
Soweto, Gauteng, South Africa
Bratislava, , Slovakia
Calgary, Alberta, Canada
Madrid, , Spain
Nürtingen, , Germany
Oshawa, Ontario, Canada
Omaha, Nebraska, United States
Huai'an, Jiangsu, China
Glendale, Arizona, United States
Chiba Shi, Chiba, Japan
Nantong, Jiangsu, China
Seoul, Jongno Gu, Korea, Republic Of
Yantai, Shandong, China
Beijing, Beijing, China
Olomouc, Olomoucký Kraj, Czechia
Terni, , Italy
Turku, Varsinais Suomi, Finland
Tübingen, , Germany
Fuzhou, Fujian, China
Myrtle Beach, South Carolina, United States
Trencin, , Slovakia
Jiaxing, , China
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Pierre Bénite, Rhône, France
Gyor, , Hungary
Plovdiv, , Bulgaria
Port Elizabeth, Eastern Cape, South Africa
Montréal, Quebec, Canada
Ankara, , Turkey
Saint Helena, California, United States
Weifang, Shandong, China
Sao Paulo, , Brazil
Rogers, Arkansas, United States
Nürtingen, Baden Württemberg, Germany
Goyang Si, Kyǒnggi Do, Korea, Republic Of
Seoul, Seoul Teukbyeolsi [Seoul], Korea, Republic Of
Reims, , France
Bordeaux, Aquitaine, France
Athens, , Greece
Kraków, Małopolskie, Poland
Buenos Aires, , Argentina
Salisbury, North Carolina, United States
Fayetteville, Arkansas, United States
Verona, , Italy
Xi'an, Shaanxi, China
São José Do Rio Preto, São Paulo, Brazil
Prague, Praha 4, Czechia
Vejle, Syddanmark, Denmark
Tampere, Pirkanmaa, Finland
Tauranga, Bay Of Plenty, New Zealand
Prague, , Czechia
Pretoria, Gauteng, South Africa
Brest, Finistère, France
Trento, , Italy
Torun, Kujawsko Pomorskie, Poland
Patras, Achaḯa, Greece
Chicoutimi, Quebec, Canada
Strasbourg, Alsace, France
Oulu, Pohjois Pohjanmaa, Finland
Athens, Attikí, Greece
Mar Del Plata, Buenos Aires, Argentina
George, Western Cape, South Africa
Pardubice, Pardubický Kraj, Czechia
Gyor, Győr Moson Sopron, Hungary
Daegu, Taegu Kwangyǒkshi, Korea, Republic Of
Madrid, Madrid, Comunidad De, Spain
Capital, Córdoba, Argentina
Wuhu, Anhui, China
Prague, , Czechia
Prague, , Czechia
Næstved, Sjælland, Denmark
Saint Herblain, Loire Atlantique, France
Le Mans, Pays De La Loire, France
Münster, Nordrhein Westfalen, Germany
Valencia, Valenciana, Comunitat, Spain
Blackburn, Blackburn With Darwen, United Kingdom
Myrtle Beach, South Carolina, United States
Tübingen, Baden Württemberg, Germany
Chaidari, Attikí, Greece
Ostrava, Moravskoslezský Kraj, Czechia
Athens, Attikí, Greece
Stockholm, , Sweden
Hwasun, Jeonranamdo, Korea, Republic Of
Roma, Lazio, Italy
Pleven, , Bulgaria
Kuopio, Pohjois Savo, Finland
Santo André, São Paulo, Brazil
Rome, Roma, Italy
Lyon Cedex08, Rhône Alpes, France
Reims, Marne, France
Natal, Rio Grande Do Norte, Brazil
Cheng Du, Sichuan, China
Phoenix, Arizona, United States
Ankara, , Turkey
Kraków, Małopolskie, Poland
Ningbo, Zhejiang, China
Meldola, Emilia Romagna, Italy
Ostrava Poruba, , Czechia
Gabrovo, , Bulgaria
Guilin, Guangxi, China
Cordoba, Córdoba, Argentina
Athens, , Greece
Jung Gu, Taejǒn Kwangyǒkshi, Korea, Republic Of
Santo André, , Brazil
São Paulo, , Brazil
Larissa, Thessalía, Greece
Lublin, Lubelskie, Poland
San Antonio, Texas, United States
Lisle, Illinois, United States
Lisle, Illinois, United States
Westmont, Illinois, United States
Gilbert, Arizona, United States
Mesa, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Myrtle Beach, South Carolina, United States
Cordoba, , Argentina
Piotrków Trybunalski, łódzkie, Poland
Sao Paulo, São Paulo, Brazil
Shantou, Guangdong, China
Hangzhou City, Zhejiang, China
Caba, Buenos Aires, Argentina
Capital Federal, Buenos Aires, Argentina
Hidden Valley Lake, California, United States
Napa, California, United States
Quincy, Illinois, United States
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Jiaxing, Zhejiang/Nanhu, China
Shenyang, , China
Prague, Praha 2, Czechia
Clermont Ferrand, , France
Miskolc, , Hungary
Suita, Osaka, Japan
Saint Grégoire, Ille Et Vilaine, France
Bronx, New York, United States
Stara Zagora, , Bulgaria
Miskolc, Borsod Abaúj Zemplén, Hungary
İstanbul, İ̇stanbul, Turkey
Mar Del Plata, Buenos Aires, Argentina
Piotrków Trybunalski, , Poland
Ostrava Poruba, Moravskoslezský Kraj, Czechia
Kraków, , Poland
Capital, , Argentina
São José Do Rio Preto, , Brazil
Pardubice, , Czechia
Jung Gu, , Korea, Republic Of
Lyon Cedex08, , France
Kraków, , Poland
Wroclaw, , Poland
Larissa, , Greece
Chaidari, , Greece
Fortaleza, , Brazil
İstanbul, , Turkey
Porto Alegre, Rio Grande Do Sul, Brazil
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported