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

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

NCT ID: NCT05546476

Condition: Non-small Cell Lung Cancer
Pancreatic Cancer
Colorectal Cancer
Loss of Appetite
Fatigue
Cachexia

Conditions: Official terms:
Wasting Syndrome
Fatigue
Cachexia
Anorexia

Conditions: Keywords:
cancer
anorexia
cachexia
weight loss
loss of appetite
fatigue

Study type: Interventional

Study phase: Phase 2

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking description: Double-blind for 12-week double-blind treatment period followed by an up to 1 year optional open-label treatment period

Intervention:

Intervention type: Drug
Intervention name: ponsegromab
Description: Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Arm group label: Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment
Arm group label: Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment
Arm group label: Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment

Intervention type: Drug
Intervention name: Placebo for ponsegromab
Description: Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment
Arm group label: Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment

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.

Criteria for eligibility:
Criteria:
Key Inclusion Criteria: - Documented active diagnosis of non-small cell lung, pancreatic, colorectal cancer - 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. Key Exclusion Criteria: - Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization. - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CARTI Conway

Address:
City: Conway
Zip: 72034
Country: United States

Facility:
Name: CARTI Cancer Center

Address:
City: Little Rock
Zip: 72205
Country: United States

Facility:
Name: CARTI North Little Rock

Address:
City: North Little Rock
Zip: 72117
Country: United States

Facility:
Name: CARTI Stuttgart

Address:
City: Stuttgart
Zip: 72160
Country: United States

Facility:
Name: Pacific Cancer Medical Center INC

Address:
City: Anaheim
Zip: 92801
Country: United States

Facility:
Name: Beverly Hills Cancer Center

Address:
City: Beverly Hills
Zip: 90211
Country: United States

Facility:
Name: Emad Ibrahim,MD,INC.

Address:
City: Redlands
Zip: 92373
Country: United States

Facility:
Name: Providence Medical Foundation

Address:
City: Santa Rosa
Zip: 95403
Country: United States

Facility:
Name: Christiana Care Health Services - Helen F. Graham Cancer Center

Address:
City: Newark
Zip: 19713
Country: United States

Facility:
Name: Christiana Care Health Services, Helen F. Graham Cancer Center Pharmacy

Address:
City: Newark
Zip: 19713
Country: United States

Facility:
Name: Christiana Care Hematology Oncology - Helen F Graham Cancer Center

Address:
City: Newark
Zip: 19713
Country: United States

Facility:
Name: Medical Oncology Hematology Consultants, P A, Helen F. Graham Cancer Center

Address:
City: Newark
Zip: 19713
Country: United States

Facility:
Name: Christiana Care Health Services - Christiana Hospital

Address:
City: Newark
Zip: 19718
Country: United States

Facility:
Name: Tallahassee Memorial HealthCare

Address:
City: Tallahassee
Zip: 32308
Country: United States

Facility:
Name: TMH Cancer Center

Address:
City: Tallahassee
Zip: 32308
Country: United States

Facility:
Name: IU Health Arnett Cancer Center

Address:
City: Lafayette
Zip: 47904
Country: United States

Facility:
Name: Baptist Health Lexington

Address:
City: Lexington
Zip: 40503
Country: United States

Facility:
Name: Pennington Biomedical Research Center

Address:
City: Baton Rouge
Zip: 70808
Country: United States

Facility:
Name: Tandem Clinical Research

Address:
City: Marrero
Zip: 70072
Country: United States

Facility:
Name: Bozeman Health Deaconess Hospital

Address:
City: Bozeman
Zip: 59715
Country: United States

Facility:
Name: Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont

Address:
City: Fremont
Zip: 68025
Country: United States

Facility:
Name: Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island

Address:
City: Grand Island
Zip: 68803
Country: United States

Facility:
Name: Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional

Address:
City: Grand Island
Zip: 68803
Country: United States

Facility:
Name: Oncology Hematology West P.C. dba Nebraska Cancer - Methodist

Address:
City: Omaha
Zip: 68114
Country: United States

Facility:
Name: Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan

Address:
City: Omaha
Zip: 68124
Country: United States

Facility:
Name: Oncology Hematology West P.C. dba Nebraska Cancer Specialists

Address:
City: Omaha
Zip: 68130
Country: United States

Facility:
Name: Oncology Hematology West P.C. dba Nebraska Cancer - Papillion

Address:
City: Papillion
Zip: 68046
Country: United States

Facility:
Name: Regional Cancer Care Associates

Address:
City: Little Silver
Zip: 07739
Country: United States

Facility:
Name: Duke Cancer Institute

Address:
City: Durham
Zip: 27710
Country: United States

Facility:
Name: Marion L. Shepard Cancer Center

Address:
City: Washington
Zip: 27889
Country: United States

Facility:
Name: Oregon Health and Science University: Center for Health and Healing 1

Address:
City: Portland
Zip: 97239
Country: United States

Facility:
Name: Oregon Health and Science University: Center for Health and Healing 2

Address:
City: Portland
Zip: 97239
Country: United States

Facility:
Name: Oregon Health and Science University

Address:
City: Portland
Zip: 97239
Country: United States

Facility:
Name: The University of Texas MD Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Facility:
Name: Carta - Clinical Associates in Research Therapeutics of America, LLC

Address:
City: San Antonio
Zip: 78212
Country: United States

Facility:
Name: Peninsula Cancer Institute

Address:
City: Newport News
Zip: 23601
Country: United States

Facility:
Name: Virginia Mason Medical Center

Address:
City: Seattle
Zip: 98101
Country: United States

Facility:
Name: VA Puget Sound Health Care System

Address:
City: Seattle
Zip: 98108
Country: United States

Facility:
Name: Medical Oncology Associates, PS (dba Summit Cancer Centers)

Address:
City: Spokane Valley
Zip: 99216
Country: United States

Facility:
Name: Medical Oncology Associates, PS (dba Summit Cancer Centers)

Address:
City: Spokane
Zip: 99208
Country: United States

Facility:
Name: Medical Oncology Associates, PS

Address:
City: Spokane
Zip: 99208
Country: United States

Facility:
Name: Central Washington Health Services Association d/b/a Confluence Health

Address:
City: Wenatchee
Zip: 98801
Country: United States

Facility:
Name: Wenatchee Valley Hospital

Address:
City: Wenatchee
Zip: 98801
Country: United States

Facility:
Name: St Vincent's Hospital Sydney

Address:
City: Darlinghurst
Zip: 2010
Country: Australia

Facility:
Name: Orange Hospital

Address:
City: Orange
Zip: 2800
Country: Australia

Facility:
Name: Prince of Wales Hospital

Address:
City: Randwick
Zip: 2031
Country: Australia

Facility:
Name: GenesisCare North Shore

Address:
City: St Leonards
Zip: 2065
Country: Australia

Facility:
Name: St Vincent's Hospital Melbourne

Address:
City: Fitzroy
Zip: 3065
Country: Australia

Facility:
Name: Peter MacCallum Cancer Centre

Address:
City: Melbourne
Zip: 3000
Country: Australia

Facility:
Name: Western Health-Sunshine & Footscray Hospitals

Address:
City: St Albans
Zip: 3021
Country: Australia

Facility:
Name: Complex Oncology Center - Burgas

Address:
City: Burgas
Zip: 8000
Country: Bulgaria

Facility:
Name: Specialized Hospital for Active Treatment of Oncology - Haskovo

Address:
City: Haskovo
Zip: 6300
Country: Bulgaria

Facility:
Name: "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD

Address:
City: Pleven
Zip: 5800
Country: Bulgaria

Facility:
Name: Complex Oncology Center - Ruse EOOD

Address:
City: Ruse
Zip: 7002
Country: Bulgaria

Facility:
Name: Complex Oncology Center - Shumen

Address:
City: Shumen
Zip: 9700
Country: Bulgaria

Facility:
Name: Multiprofile Hospital for Active Treatment Serdika EOOD

Address:
City: Sofia
Zip: 1303
Country: Bulgaria

Facility:
Name: MHAT for Women's Health Nadezhda

Address:
City: Sofia
Zip: 1330
Country: Bulgaria

Facility:
Name: University Specialized Hospital for Active Treatment of Oncology EAD

Address:
City: Sofia
Zip: 1756
Country: Bulgaria

Facility:
Name: University Multiprofile Hospital for Active Treatment Sofiamed

Address:
City: Sofia
Zip: 1797
Country: Bulgaria

Facility:
Name: Complex Oncology Center - Vratsa

Address:
City: Vratsa
Zip: 3000
Country: Bulgaria

Facility:
Name: William Osler Health System

Address:
City: Brampton
Zip: L6R 3J7
Country: Canada

Facility:
Name: Victoria Hospital & Children's Hospital - London Health Sciences Centre

Address:
City: London
Zip: N6A 5W9
Country: Canada

Facility:
Name: The Ottawa Hospital - General Campus

Address:
City: Ottawa
Zip: K1H 8L6
Country: Canada

Facility:
Name: Princess Margaret Cancer Centre

Address:
City: Toronto
Zip: M5G 2M9
Country: Canada

Facility:
Name: CIUSSS- saguenay-Lac-Saint-Jean

Address:
City: Chicoutimi
Zip: G7H 5H6
Country: Canada

Facility:
Name: Centre Hospitalier Regional De Rimouski

Address:
City: Rimouski
Zip: G5L 5T1
Country: Canada

Facility:
Name: Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski

Address:
City: Rimouski
Zip: G5L 5T1
Country: Canada

Facility:
Name: Peking University First Hospital

Address:
City: Beijing
Zip: 100034
Country: China

Facility:
Name: Henan Cancer Hospital

Address:
City: Zhengzhou
Zip: 450008
Country: China

Facility:
Name: Tongji Hospital Tongji Medical,Science & Technology

Address:
City: Wuhan
Zip: 430030
Country: China

Facility:
Name: Changzhou No.2 People's Hospital

Address:
City: Changzhou
Zip: 213003
Country: China

Facility:
Name: Changzhou No.2 People's Hospital

Address:
City: Changzhou
Zip: 213004
Country: China

Facility:
Name: Changzhou No.2 People's Hospital

Address:
City: Changzhou
Zip: 213100
Country: China

Facility:
Name: The First Affiliated Hospital of Nanchang University

Address:
City: Nanchang
Zip: 330006
Country: China

Facility:
Name: Qilu Hospital of Shandong University

Address:
City: Jinan
Zip: 250012
Country: China

Facility:
Name: Shanghai Changhai Hospital

Address:
City: Shanghai
Zip: 200433
Country: China

Facility:
Name: Shanxi Provincial Cancer Hospital

Address:
City: Taiyuan
Zip: 030013
Country: China

Facility:
Name: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310016
Country: China

Facility:
Name: The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Address:
City: Wenzhou
Zip: 325035
Country: China

Facility:
Name: Fakultni nemocnice Olomouc

Address:
City: Olomouc
Zip: 779 00
Country: Czechia

Facility:
Name: Fakultni nemocnice Bulovka

Address:
City: Prague
Zip: 180 81
Country: Czechia

Facility:
Name: Res Medica s.r.o.

Address:
City: Novy Knin
Zip: 26203
Country: Czechia

Facility:
Name: Oblastní nemocnice Příbram, a.s.

Address:
City: Příbram
Zip: 261 01
Country: Czechia

Facility:
Name: Bacs-Kiskun Varmegyei Oktatokorhaz

Address:
City: Kecskemét
Zip: 6000
Country: Hungary

Facility:
Name: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház

Address:
City: Szolnok
Zip: 5004
Country: Hungary

Facility:
Name: Semmelweis Egyetem

Address:
City: Budapest
Zip: 1083
Country: Hungary

Facility:
Name: Országos Korányi Pulmonológiai Intézet

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: National Cancer Center Hospital East

Address:
City: Kashiwa
Zip: 277-8577
Country: Japan

Facility:
Name: National Hospital Organization Shikoku Cancer Center

Address:
City: Matsuyama
Zip: 791-0280
Country: Japan

Facility:
Name: Hyogo Cancer Center

Address:
City: Akashi
Zip: 673-8558
Country: Japan

Facility:
Name: Kanagawa cancer center

Address:
City: Yokohama
Zip: 241-8515
Country: Japan

Facility:
Name: Aichi Cancer Center Hospital

Address:
City: Nagoya
Zip: 464-8681
Country: Japan

Facility:
Name: Shizuoka Cancer Center

Address:
City: Nagaizumi-cho,Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: Japanese Foundation For Cancer Research Cancer Institute Hospital

Address:
City: Koto-Ku
Zip: 135-8550
Country: Japan

Facility:
Name: University Hospital,Kyoto Prefectural University of Medicine

Address:
City: Kyoto
Zip: 602-8566
Country: Japan

Facility:
Name: Japanese Foundation for Cancer Research

Address:
City: Tokyo
Zip: 135-8550
Country: Japan

Facility:
Name: Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.

Address:
City: Kraków
Zip: 30-348
Country: Poland

Facility:
Name: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

Address:
City: Kraków
Zip: 31-826
Country: Poland

Facility:
Name: Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej

Address:
City: Biala Podlaska
Zip: 21-500
Country: Poland

Facility:
Name: Szpital Specjalistyczny w Prabutach Spolka z o.o.

Address:
City: Prabuty
Zip: 82-550
Country: Poland

Facility:
Name: Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego

Address:
City: Grudziadz
Zip: 86-300
Country: Poland

Facility:
Name: NZOZ "Vegamed"

Address:
City: Katowice
Zip: 40-060
Country: Poland

Facility:
Name: Specjalistyczna Praktyka Lekarska Slawomir Mandziuk

Address:
City: Lublin
Zip: 20-093
Country: Poland

Facility:
Name: Centrum Pulmonologii i Torakochirurgii w Bystrej

Address:
City: Bystra
Zip: 43-360
Country: Poland

Facility:
Name: Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica

Address:
City: Banska Bystrica
Zip: 975 17
Country: Slovakia

Facility:
Name: Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Address:
City: Bratislava
Zip: 826 06
Country: Slovakia

Facility:
Name: Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOU

Address:
City: Bratislava
Zip: 833 10
Country: Slovakia

Facility:
Name: Specializovana nemocnica sv. Svorada Zobor, n.o.

Address:
City: Nitra
Zip: 949 88
Country: Slovakia

Facility:
Name: Fakultna nemocnica s poliklinikou Nove Zamky

Address:
City: Nove Zamky
Zip: 940 34
Country: Slovakia

Facility:
Name: Nemocnica na okraji mesta, n.o.

Address:
City: Partizanske
Zip: 95801
Country: Slovakia

Facility:
Name: Fakultna nemocnica Trnava

Address:
City: Trnava
Zip: 917 75
Country: Slovakia

Facility:
Name: Hospital Universitari Vall d'Hebron

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Universitari General de Catalunya

Address:
City: Sant Cugat del Vallès
Zip: 08915
Country: Spain

Facility:
Name: Institut Català d'Oncologia - L'Hospitalet

Address:
City: L'Hospitalet de Llobregat
Zip: 08908
Country: Spain

Facility:
Name: Hospital Son Llàtzer

Address:
City: Palma
Zip: 07198
Country: Spain

Facility:
Name: Fundación Instituto Valenciano de Oncología

Address:
City: Valencia
Zip: 46009
Country: Spain

Facility:
Name: Hospital Universitario HM Sanchinarro

Address:
City: Madrid
Zip: 28050
Country: Spain

Facility:
Name: Hospital Universitari i Politecnic La Fe

Address:
City: València
Zip: 46026
Country: Spain

Facility:
Name: Chi Mei Hospital - Liouying Branch

Address:
City: Tainan City
Zip: 73657
Country: Taiwan

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital

Address:
City: Kaohsiung
Zip: 80756
Country: Taiwan

Facility:
Name: China Medical University Hospital

Address:
City: Taichung
Zip: 404332
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: Koo Foundation Sun Yat-Sen Cancer Center

Address:
City: Taipei
Zip: 112
Country: Taiwan

Facility:
Name: Chang Gung Medical Foundation-Linkou Branch

Address:
City: Taoyuan
Zip: 333
Country: Taiwan

Start date: November 21, 2022

Completion date: April 30, 2025

Lead sponsor:
Agency: Pfizer
Agency class: Industry

Source: Pfizer

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05546476
https://pmiform.com/clinical-trial-info-request?StudyID=C3651003