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COMPLETED
NCT05546476
PHASE2

Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

Sponsor: Pfizer

View on ClinicalTrials.gov

Summary

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

187

Start Date

2022-11-21

Completion Date

2025-04-23

Last Updated

2026-06-03

Healthy Volunteers

No

Interventions

DRUG

ponsegromab

Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment

DRUG

Placebo for ponsegromab

Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment

Locations (78)

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 Megyei 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, Tainan, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, Taiwan