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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05546476
Other study ID # C3651003
Secondary ID 2022-003016-87
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date November 21, 2022
Est. completion date April 30, 2025

Study information

Verified date June 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 187
Est. completion date April 30, 2025
Est. primary completion date March 13, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
ponsegromab
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Placebo for ponsegromab
Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment

Locations

Country Name City State
Australia St Vincent's Hospital Sydney Darlinghurst New South Wales
Australia St Vincent's Hospital Melbourne Fitzroy Victoria
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Orange Hospital Orange New South Wales
Australia Prince of Wales Hospital Randwick New South Wales
Australia Western Health-Sunshine & Footscray Hospitals St Albans Victoria
Australia GenesisCare North Shore St Leonards New South Wales
Bulgaria 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 MHAT for Women's Health Nadezhda Sofia
Bulgaria Multiprofile Hospital for Active Treatment Serdika EOOD Sofia
Bulgaria University Multiprofile Hospital for Active Treatment Sofiamed Sofia
Bulgaria University Specialized Hospital for Active Treatment of Oncology EAD Sofia
Bulgaria Complex Oncology Center - Vratsa Vratsa
Canada William Osler Health System Brampton Ontario
Canada CIUSSS- saguenay-Lac-Saint-Jean Chicoutimi Quebec
Canada Victoria Hospital & Children's Hospital - London Health Sciences Centre London Ontario
Canada The Ottawa Hospital - General Campus Ottawa Ontario
Canada Centre Hospitalier Regional De Rimouski Rimouski Quebec
Canada Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimouski Rimouski Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario
China Peking University First Hospital Beijing Beijing
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 Sir Run Run Shaw Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang
China Qilu Hospital of Shandong University Jinan Shandong
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Shanghai Changhai Hospital Shanghai Shanghai
China Shanxi Provincial Cancer Hospital Taiyuan Shanxi
China The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University Wenzhou Zhejiang
China Tongji Hospital Tongji Medical,Science & Technology Wuhan Hubei
China Henan Cancer Hospital Zhengzhou Henan
Czechia Res Medica s.r.o. Novy Knin Stredoceský KRAJ
Czechia Fakultni nemocnice Olomouc Olomouc Olomoucký KRAJ
Czechia Fakultni nemocnice Bulovka Prague Praha 8
Czechia Oblastní nemocnice Príbram, a.s. Príbram Stredoceský KRAJ
Hungary Országos Korányi Pulmonológiai Intézet Budapest
Hungary Semmelweis Egyetem Budapest
Hungary Bacs-Kiskun Varmegyei Oktatokorhaz Kecskemét Bács-kiskun
Hungary Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház Szolnok Jász-nagykun-szolnok
Japan Hyogo Cancer Center Akashi Hyogo
Japan National Cancer Center Hospital East Kashiwa Chiba
Japan Japanese Foundation For Cancer Research Cancer Institute Hospital Koto-Ku Tokyo
Japan University Hospital,Kyoto Prefectural University of Medicine Kyoto
Japan National Hospital Organization Shikoku Cancer Center Matsuyama Ehime
Japan Shizuoka Cancer Center Nagaizumi-cho,Sunto-gun Shizuoka
Japan Aichi Cancer Center Hospital Nagoya Nagoya, Aichi
Japan Japanese Foundation for Cancer Research Tokyo
Japan Kanagawa cancer center Yokohama Kanagawa
Poland Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej Biala Podlaska Podlaskie
Poland Centrum Pulmonologii i Torakochirurgii w Bystrej Bystra Slaskie
Poland Regionalny Szpital Specjalistyczny im. Dr. Wladyslawa Bieganskiego Grudziadz
Poland NZOZ "Vegamed" Katowice
Poland Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji sp. z o.o. Kraków Malopolskie
Poland Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Kraków Malopolskie
Poland Specjalistyczna Praktyka Lekarska Slawomir Mandziuk Lublin
Poland Szpital Specjalistyczny w Prabutach Spolka z o.o. Prabuty Pomorskie
Slovakia Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica Banska Bystrica
Slovakia Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOU Bratislava
Slovakia Univerzitna nemocnica Bratislava, Nemocnica Ruzinov 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
Spain Hospital Universitari Vall d'Hebron Barcelona Barcelona [barcelona]
Spain Institut Català d'Oncologia - L'Hospitalet L'Hospitalet de Llobregat Catalunya [cataluña]
Spain Hospital Universitario HM Sanchinarro Madrid
Spain Hospital Son Llàtzer Palma Illes Balears [islas Baleares]
Spain Hospital Universitari General de Catalunya Sant Cugat del Vallès Barcelona [barcelona]
Spain Fundación Instituto Valenciano de Oncología Valencia Valenciana, Comunitat
Spain Hospital Universitari i Politecnic La Fe València
Taiwan Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan National Cheng Kung University Hospital Tainan
Taiwan Chi Mei Hospital - Liouying Branch Tainan City Tainan
Taiwan Koo Foundation Sun Yat-Sen Cancer Center Taipei
Taiwan Chang Gung Medical Foundation-Linkou Branch Taoyuan
United States Pacific Cancer Medical Center INC Anaheim California
United States Pennington Biomedical Research Center Baton Rouge Louisiana
United States Beverly Hills Cancer Center Beverly Hills California
United States Bozeman Health Deaconess Hospital Bozeman Montana
United States CARTI Conway Conway Arkansas
United States Duke Cancer Institute Durham North Carolina
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 The University of Texas MD Anderson Cancer Center Houston Texas
United States IU Health Arnett Cancer Center Lafayette Indiana
United States Baptist Health Lexington Lexington Kentucky
United States CARTI Cancer Center Little Rock Arkansas
United States Regional Cancer Care Associates Little Silver New Jersey
United States Tandem Clinical Research Marrero Louisiana
United States Christiana Care Health Services - Christiana Hospital Newark Delaware
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 Peninsula Cancer Institute Newport News Virginia
United States CARTI North Little Rock North Little Rock Arkansas
United States Oncology Hematology West P.C. dba Nebraska Cancer - Methodist Omaha Nebraska
United States Oncology Hematology West P.C. dba Nebraska Cancer Specialists 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 - Papillion Papillion Nebraska
United States Oregon Health and Science University Portland Oregon
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 Emad Ibrahim,MD,INC. Redlands California
United States Carta - Clinical Associates in Research Therapeutics of America, LLC San Antonio Texas
United States Providence Medical Foundation Santa Rosa California
United States VA Puget Sound Health Care System Seattle Washington
United States Virginia Mason Medical Center Seattle Washington
United States Medical Oncology Associates, PS Spokane Washington
United States Medical Oncology Associates, PS (dba Summit Cancer Centers) Spokane Washington
United States Medical Oncology Associates, PS (dba Summit Cancer Centers) Spokane Valley Washington
United States CARTI Stuttgart Stuttgart Arkansas
United States Tallahassee Memorial HealthCare Tallahassee Florida
United States TMH Cancer Center Tallahassee Florida
United States Marion L. Shepard Cancer Center Washington North Carolina
United States Central Washington Health Services Association d/b/a Confluence Health Wenatchee Washington
United States Wenatchee Valley Hospital Wenatchee Washington

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Bulgaria,  Canada,  China,  Czechia,  Hungary,  Japan,  Poland,  Slovakia,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in body weight for ponsegromab compared to placebo baseline, Week 12
Secondary Change from baseline in physical activity as measured with remote digital sensors evaluation of physical activity (Sedentary, light and moderate) and gait speed. baseline, Week 12
Secondary change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS and FAACT-5IASS) scores FACT-G score sums 27 items; ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life. baseline, Week 12
Secondary Change from baseline in anorexia/appetite; Nausea and vomiting; and Fatigue as measured by the Cancer Related Cachexia Symptom Diary (CRCSD) Self-reported questionnaire that measures severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue. baseline, Week 12
Secondary Incidence of adverse events Week 12
Secondary Incidence of lab abnormalities Week 12
Secondary Incidence of vital sign abnormalities Week 12
Secondary Incidence of ECG abnormalities Week 12
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