Spots Global Cancer Trial Database for Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
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Trial Identification
Brief Title: Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
Official Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PONSEGROMAB IN PATIENTS WITH CANCER, CACHEXIA, AND ELEVATED CONCENTRATIONS OF GDF-15, FOLLOWED BY AN OPTIONAL OPEN-LABEL TREATMENT PERIOD (PROACC -1)
Study ID: NCT05546476
Study Description
Brief Summary: Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.
Detailed Description: A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15. During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo. Assessments include: * Body weight measurements * Measure the impact of ponsegromab compared to placebo on physical activity. * Measure the impact of ponsegromab compared to placebo on appetite, fatigue, nausea, vomiting and physical function questionnaires. * Blood samples to evaluate safety and additional endpoints including the amount of study drug in the blood and the effects of the study drug on levels of GDF15 * Up to 3 additional blood samples (two samples during Part A and one sample during Part B, if relevant) in a subset of participants as part of a substudy for more comprehensive assessment of the amount of study drug in the blood and of the effects of the study drug on levels of GDF-15.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CARTI Conway, Conway, Arkansas, United States
CARTI Cancer Center, Little Rock, Arkansas, United States
CARTI North Little Rock, North Little Rock, Arkansas, United States
CARTI Stuttgart, Stuttgart, Arkansas, United States
Pacific Cancer Medical Center INC, Anaheim, California, United States
Beverly Hills Cancer Center, Beverly Hills, California, United States
Emad Ibrahim,MD,INC., Redlands, California, United States
Providence Medical Foundation, Santa Rosa, California, United States
Christiana Care Health Services - Helen F. Graham Cancer Center, Newark, Delaware, United States
Christiana Care Health Services, Helen F. Graham Cancer Center Pharmacy, Newark, Delaware, United States
Christiana Care Hematology Oncology - Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants, P A, Helen F. Graham Cancer Center, Newark, Delaware, United States
Christiana Care Health Services - Christiana Hospital, Newark, Delaware, United States
Tallahassee Memorial HealthCare, Tallahassee, Florida, United States
TMH Cancer Center, Tallahassee, Florida, United States
IU Health Arnett Cancer Center, Lafayette, Indiana, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States
Tandem Clinical Research, Marrero, Louisiana, United States
Bozeman Health Deaconess Hospital, Bozeman, Montana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont, Fremont, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island, Grand Island, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional, Grand Island, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer - Methodist, Omaha, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan, Omaha, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer Specialists, Omaha, Nebraska, United States
Oncology Hematology West P.C. dba Nebraska Cancer - Papillion, Papillion, Nebraska, United States
Regional Cancer Care Associates, Little Silver, New Jersey, United States
Duke Cancer Institute, Durham, North Carolina, United States
Marion L. Shepard Cancer Center, Washington, North Carolina, United States
Oregon Health and Science University: Center for Health and Healing 1, Portland, Oregon, United States
Oregon Health and Science University: Center for Health and Healing 2, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Carta - Clinical Associates in Research Therapeutics of America, LLC, San Antonio, Texas, United States
Peninsula Cancer Institute, Newport News, Virginia, United States
Virginia Mason Medical Center, Seattle, Washington, United States
VA Puget Sound Health Care System, Seattle, Washington, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers), Spokane Valley, Washington, United States
Medical Oncology Associates, PS (dba Summit Cancer Centers), Spokane, Washington, United States
Medical Oncology Associates, PS, Spokane, Washington, United States
Central Washington Health Services Association d/b/a Confluence Health, Wenatchee, Washington, United States
Wenatchee Valley Hospital, Wenatchee, Washington, United States
St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia
Orange Hospital, Orange, New South Wales, Australia
Prince of Wales Hospital, Randwick, New South Wales, Australia
GenesisCare North Shore, St Leonards, New South Wales, Australia
St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Western Health-Sunshine & Footscray Hospitals, St Albans, Victoria, Australia
Complex Oncology Center - Burgas, Burgas, , Bulgaria
Specialized Hospital for Active Treatment of Oncology - Haskovo, Haskovo, , Bulgaria
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD, Pleven, , Bulgaria
Complex Oncology Center - Ruse EOOD, Ruse, , Bulgaria
Complex Oncology Center - Shumen, Shumen, , Bulgaria
Multiprofile Hospital for Active Treatment Serdika EOOD, Sofia, , Bulgaria
MHAT for Women's Health Nadezhda, Sofia, , Bulgaria
University Specialized Hospital for Active Treatment of Oncology EAD, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed, Sofia, , Bulgaria
Complex Oncology Center - Vratsa, Vratsa, , Bulgaria
William Osler Health System, Brampton, Ontario, Canada
Victoria Hospital & Children's Hospital - London Health Sciences Centre, London, Ontario, Canada
The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean, Chicoutimi, Quebec, Canada
Centre Hospitalier Regional De Rimouski, Rimouski, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimousk, Rimouski, Quebec, Canada
Peking University First Hospital, Beijing, Beijing, China
Henan Cancer Hospital, Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology, Wuhan, Hubei, China
Changzhou No.2 People's Hospital, Changzhou, Jiangsu, China
Changzhou No.2 People's Hospital, Changzhou, Jiangsu, China
Changzhou No.2 People's Hospital, Changzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, China
Qilu Hospital of Shandong University, Jinan, Shandong, China
Shanghai Changhai Hospital, Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital, Taiyuan, Shanxi, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China
Fakultni nemocnice Olomouc, Olomouc, Olomoucký KRAJ, Czechia
Fakultni nemocnice Bulovka, Prague, Praha 8, Czechia
Res Medica s.r.o., Novy Knin, Středočeský KRAJ, Czechia
Oblastní nemocnice Příbram, a.s., Příbram, Středočeský KRAJ, Czechia
Bacs-Kiskun Varmegyei Oktatokorhaz, Kecskemét, Bács-kiskun, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház, Szolnok, Jász-nagykun-szolnok, Hungary
Semmelweis Egyetem, Budapest, , Hungary
Országos Korányi Pulmonológiai Intézet, Budapest, , Hungary
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Kanagawa cancer center, Yokohama, Kanagawa, Japan
Aichi Cancer Center Hospital, Nagoya, Nagoya, Aichi, Japan
Shizuoka Cancer Center, Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
Japanese Foundation For Cancer Research Cancer Institute Hospital, Koto-Ku, Tokyo, Japan
University Hospital,Kyoto Prefectural University of Medicine, Kyoto, , Japan
Japanese Foundation for Cancer Research, Tokyo, , Japan
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o., Kraków, Małopolskie, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie, Kraków, Małopolskie, Poland
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej, Biala Podlaska, Podlaskie, Poland
Szpital Specjalistyczny w Prabutach Spolka z o.o., Prabuty, Pomorskie, Poland
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego, Grudziadz, , Poland
NZOZ "Vegamed", Katowice, , Poland
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk, Lublin, , Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej, Bystra, Śląskie, Poland
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica, Banska Bystrica, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov, Bratislava, , Slovakia
Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOU, Bratislava, , Slovakia
Specializovana nemocnica sv. Svorada Zobor, n.o., Nitra, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky, Nove Zamky, , Slovakia
Nemocnica na okraji mesta, n.o., Partizanske, , Slovakia
Fakultna nemocnica Trnava, Trnava, , Slovakia
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [barcelona], Spain
Hospital Universitari General de Catalunya, Sant Cugat del Vallès, Barcelona [barcelona], Spain
Institut Català d'Oncologia - L'Hospitalet, L'Hospitalet de Llobregat, Catalunya [cataluña], Spain
Hospital Son Llàtzer, Palma, Illes Balears [islas Baleares], Spain
Fundación Instituto Valenciano de Oncología, Valencia, Valenciana, Comunitat, Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitari i Politecnic La Fe, València, , Spain
Chi Mei Hospital - Liouying Branch, Tainan City, Tainan, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center, Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch, Taoyuan, , Taiwan
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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