Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
NCT ID: NCT05546476
Last Updated: 2025-05-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
187 participants
INTERVENTIONAL
2022-11-21
2025-04-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment
ponsegromab low dose subcutaneous injection every 4 weeks
ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment
Match placebo subcutaneous injection every 4 weeks
Placebo for ponsegromab
Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment
Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment
ponsegromab medium dose subcutaneous injection every 4 weeks
ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment
ponsegromab high dose subcutaneous injection every 4 weeks
ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Interventions
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ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Placebo for ponsegromab
Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment
Eligibility Criteria
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Inclusion Criteria
* Cachexia defined by Fearon criteria of weight loss
* Serum GDF-15 concentrations
* Signed informed consent
* ECOG PS ≤3 with life expectancy of at least 4 months to be able to complete Part A.
Exclusion Criteria
* Current active reversible causes of decreased food intake.
* Cachexia caused by other reasons.
* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
* inadequate liver function
* renal disease requiring dialysis
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
IU Health Arnett Cancer Center
Lafayette, Indiana, 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
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
Virginia Mason Medical Center
Seattle, 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
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
Complex Oncology Center - Ruse EOOD
Rousse, , 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 Multiprofile Hospital for Active Treatment Sofiamed
Sofia, , Bulgaria
Complex Oncology Center - Vratsa
Vratsa, , Bulgaria
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski
Rimouski, Quebec, Canada
Peking University First Hospital
Beijing, Beijing Municipality, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 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 Municipality, 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
Bacs-Kiskun Varmegyei Oktatokorhaz
Kecskemét, Bács-Kiskun county, 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, Hyōgo, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
Aichi Cancer Center Hospital
Nagoya, Nagoya, Aichi, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, , Japan
The Cancer Institute Hospital of JFCR
Tokyo, , Japan
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
Krakow, Lesser Poland Voivodeship, Poland
Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego
Grudziądz, , Poland
NZOZ "Vegamed"
Katowice, , Poland
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
Lublin, , Poland
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
Banská Bystrica, , Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
Bratislava, , Slovakia
Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOU
Bratislava, , Slovakia
Fakultna nemocnica s poliklinikou Nove Zamky
Nové Zámky, , Slovakia
Nemocnica na okraji mesta, n.o.
Partizánske, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
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
Valencia, , Spain
Chi Mei Hospital - Liouying Branch
Tainan City, Tainan, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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References
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Groarke JD, Crawford J, Collins SM, Lubaczewski S, Roeland EJ, Naito T, Hendifar AE, Fallon M, Takayama K, Asmis T, Dunne RF, Karahanoglu I, Northcott CA, Harrington MA, Rossulek M, Qiu R, Saxena AR. Ponsegromab for the Treatment of Cancer Cachexia. N Engl J Med. 2024 Dec 19;391(24):2291-2303. doi: 10.1056/NEJMoa2409515. Epub 2024 Sep 14.
Groarke JD, Crawford J, Collins SM, Lubaczewski SL, Breen DM, Harrington MA, Jacobs I, Qiu R, Revkin J, Rossulek MI, Saxena AR. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC-1 study design. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1054-1061. doi: 10.1002/jcsm.13435. Epub 2024 Mar 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-510446-24-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
C3651003
Identifier Type: -
Identifier Source: org_study_id
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