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

Colorectal Cancer Clinical Trial

— PROACC-1  

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)

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
• Start date: November 21, 2022
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Anorexia
• Cachexia
• Colorectal Cancer
• Fatigue
• Loss of Appetite
• Non-small Cell Lung Cancer
• Pancreatic Cancer

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 Rimousk	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

External Links

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