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Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15 (PROACC-1)

Primary Purpose

Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ponsegromab
Placebo for ponsegromab
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Documented diagnosis of non-small cell lung, pancreatic, colorectal cancer
  • Cachexia defined by Fearon criteria
  • Serum GDF-15 concentrations
  • Signed informed consent

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 renal or liver function

Sites / Locations

  • CARTI ConwayRecruiting
  • CARTI Cancer CenterRecruiting
  • CARTI North Little RockRecruiting
  • CARTI StuttgartRecruiting
  • Pacific Cancer Medical Center INCRecruiting
  • Beverly Hills Cancer CenterRecruiting
  • Emad Ibrahim,MD,INC.Recruiting
  • Providence Medical FoundationRecruiting
  • Christiana Care Health Services - Helen F. Graham Cancer CenterRecruiting
  • Christiana Care Health Services, Helen F. Graham Cancer Center PharmacyRecruiting
  • Christiana Care Hematology Oncology - Helen F Graham Cancer CenterRecruiting
  • Medical Oncology Hematology Consultants, P A, Helen F. Graham Cancer CenterRecruiting
  • Christiana Care Health Services - Christiana HospitalRecruiting
  • Tallahassee Memorial HealthCareRecruiting
  • TMH Cancer CenterRecruiting
  • IU Health Arnett Cancer CenterRecruiting
  • Baptist Health LexingtonRecruiting
  • Pennington Biomedical Research CenterRecruiting
  • Tandem Clinical Research
  • Tandem Clinical ResearchRecruiting
  • Bozeman Health Deaconess HospitalRecruiting
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
  • Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
  • Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
  • Oncology Hematology West P.C. dba Nebraska Cancer Specialists
  • Oncology Hematology West P.C. dba Nebraska Cancer - Papillion
  • Regional Cancer Care Associates
  • Duke Cancer InstituteRecruiting
  • Marion L. Shepard Cancer CenterRecruiting
  • Oregon Health and Science University: Center for Health and Healing 1Recruiting
  • Oregon Health and Science University: Center for Health and Healing 2Recruiting
  • Oregon Health and Science UniversityRecruiting
  • The University of Texas MD Anderson Cancer CenterRecruiting
  • Carta - Clinical Associates in Research Therapeutics of America, LLCRecruiting
  • Peninsula Cancer InstituteRecruiting
  • Virginia Mason Medical CenterRecruiting
  • VA Puget Sound Health Care SystemRecruiting
  • Medical Oncology Associates, PS (dba Summit Cancer Centers)Recruiting
  • Medical Oncology Associates, PS (dba Summit Cancer Centers)Recruiting
  • Medical Oncology Associates, PSRecruiting
  • Central Washington Health Services Association d/b/a Confluence Health
  • Wenatchee Valley HospitalRecruiting
  • St Vincent's Hospital SydneyRecruiting
  • Orange HospitalRecruiting
  • Prince of Wales HospitalRecruiting
  • GenesisCare North Shore
  • GenesisCare North ShoreRecruiting
  • St Vincent's Hospital MelbourneRecruiting
  • Peter MacCallum Cancer CentreRecruiting
  • Western Health-Sunshine & Footscray HospitalsRecruiting
  • Complex Oncology Center - BurgasRecruiting
  • Specialized Hospital for Active Treatment of Oncology - HaskovoRecruiting
  • "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EADRecruiting
  • Complex Oncology Center - Ruse EOODRecruiting
  • Complex Oncology Center - ShumenRecruiting
  • Multiprofile Hospital for Active Treatment Serdika EOODRecruiting
  • MHAT for Women's Health NadezhdaRecruiting
  • University Specialized Hospital for Active Treatment of Oncology EADRecruiting
  • University Multiprofile Hospital for Active Treatment SofiamedRecruiting
  • Complex Oncology Center - VratsaRecruiting
  • William Osler Health SystemRecruiting
  • Victoria Hospital & Children's Hospital - London Health Sciences CentreRecruiting
  • The Ottawa Hospital - General CampusRecruiting
  • Princess Margaret Cancer CentreRecruiting
  • CIUSSS- saguenay-Lac-Saint-Jean
  • CIUSSS- saguenay-Lac-Saint-JeanRecruiting
  • Centre Hospitalier Regional De RimouskiRecruiting
  • Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de RimousRecruiting
  • Peking University First HospitalRecruiting
  • Henan Cancer HospitalRecruiting
  • Tongji Hospital Tongji Medical,Science & TechnologyRecruiting
  • Changzhou No.2 People's HospitalRecruiting
  • Changzhou No.2 People's HospitalRecruiting
  • Changzhou No.2 People's HospitalRecruiting
  • The First Affiliated Hospital of Nanchang UniversityRecruiting
  • Qilu Hospital of Shandong UniversityRecruiting
  • Shanghai Changhai HospitalRecruiting
  • Shanxi Provincial Cancer HospitalRecruiting
  • Sir Run Run Shaw Hospital of Zhejiang University School of MedicineRecruiting
  • The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical UniversityRecruiting
  • Fakultni nemocnice Olomouc
  • Fakultni nemocnice Bulovka
  • Res Medica s.r.o.
  • Oblastní nemocnice Příbram, a.s.
  • Bacs-Kiskun Varmegyei Oktatokorhaz
  • Jász-Nagykun-Szolnok Megyei Hetényi Géza KórházRecruiting
  • Semmelweis Egyetem
  • Országos Korányi Pulmonológiai IntézetRecruiting
  • National Cancer Center Hospital EastRecruiting
  • National Hospital Organization Shikoku Cancer CenterRecruiting
  • Hyogo Cancer CenterRecruiting
  • Kanagawa cancer centerRecruiting
  • Aichi Cancer Center HospitalRecruiting
  • Shizuoka Cancer CenterRecruiting
  • Japanese Foundation For Cancer Research Cancer Institute HospitalRecruiting
  • University Hospital,Kyoto Prefectural University of Medicine
  • University Hospital,Kyoto Prefectural University of MedicineRecruiting
  • Japanese Foundation for Cancer ResearchRecruiting
  • Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.Recruiting
  • Szpital Specjalistyczny im. Ludwika Rydygiera w KrakowieRecruiting
  • Wojewodzki Szpital Specjalistyczny w Bialej PodlaskiejRecruiting
  • Szpital Specjalistyczny w Prabutach Spolka z o.o.Recruiting
  • Regionalny Szpital Specjalistyczny im. dr. Władyslawa BiegańskiegoRecruiting
  • NZOZ "Vegamed"Recruiting
  • Specjalistyczna Praktyka Lekarska Slawomir MandziukRecruiting
  • Centrum Pulmonologii i Torakochirurgii w Bystrej
  • Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska BystricaRecruiting
  • Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
  • Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOURecruiting
  • Specializovana nemocnica sv. Svorada Zobor, n.o.Recruiting
  • Fakultna nemocnica s poliklinikou Nove ZamkyRecruiting
  • Nemocnica na okraji mesta, n.o.Recruiting
  • Fakultna nemocnica TrnavaRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitari General de CatalunyaRecruiting
  • Institut Català d'Oncologia - L'HospitaletRecruiting
  • Hospital Son LlàtzerRecruiting
  • Fundación Instituto Valenciano de OncologíaRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Chi Mei Hospital - Liouying BranchRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Koo Foundation Sun Yat-Sen Cancer CenterRecruiting
  • Chang Gung Medical Foundation-Linkou BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment

Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment

Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment

Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment

Arm Description

ponsegromab low dose subcutaneous injection every 4 weeks

Match placebo subcutaneous injection every 4 weeks

ponsegromab medium dose subcutaneous injection every 4 weeks

ponsegromab high dose subcutaneous injection every 4 weeks

Outcomes

Primary Outcome Measures

Change from baseline in body weight for ponsegromab compared to placebo

Secondary Outcome Measures

Change from baseline in physical activity as measured with remote digital sensors
evaluation of physical activity (Sedentary, light and moderate) and gait speed.
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.
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.
Incidence of adverse events
Incidence of lab abnormalities
Incidence of vital sign abnormalities
Incidence of ECG abnormalities

Full Information

First Posted
August 12, 2022
Last Updated
October 4, 2023
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT05546476
Brief Title
Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Loss of Appetite, Fatigue, Cachexia
Keywords
cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind for 12-week double-blind treatment period followed by an up to 1 year optional open-label treatment period
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment
Arm Type
Experimental
Arm Description
ponsegromab low dose subcutaneous injection every 4 weeks
Arm Title
Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment
Arm Type
Placebo Comparator
Arm Description
Match placebo subcutaneous injection every 4 weeks
Arm Title
Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment
Arm Type
Experimental
Arm Description
ponsegromab medium dose subcutaneous injection every 4 weeks
Arm Title
Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment
Arm Type
Experimental
Arm Description
ponsegromab high dose subcutaneous injection every 4 weeks
Intervention Type
Drug
Intervention Name(s)
ponsegromab
Intervention Description
Double-Blind ponsegromab Treatment followed by Open Label ponsegromab Treatment
Intervention Type
Drug
Intervention Name(s)
Placebo for ponsegromab
Intervention Description
Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment
Primary Outcome Measure Information:
Title
Change from baseline in body weight for ponsegromab compared to placebo
Time Frame
baseline, Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in physical activity as measured with remote digital sensors
Description
evaluation of physical activity (Sedentary, light and moderate) and gait speed.
Time Frame
baseline, Week 12
Title
change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS and FAACT-5IASS) scores
Description
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.
Time Frame
baseline, Week 12
Title
Change from baseline in anorexia/appetite; Nausea and vomiting; and Fatigue as measured by the Cancer Related Cachexia Symptom Diary (CRCSD)
Description
Self-reported questionnaire that measures severity of symptoms related to cancer cachexia: appetite, nausea, vomiting, and fatigue.
Time Frame
baseline, Week 12
Title
Incidence of adverse events
Time Frame
Week 12
Title
Incidence of lab abnormalities
Time Frame
Week 12
Title
Incidence of vital sign abnormalities
Time Frame
Week 12
Title
Incidence of ECG abnormalities
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pfizer CT.gov Call Center
Phone
1-800-718-1021
Email
ClinicalTrials.gov_Inquiries@pfizer.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
CARTI Conway
City
Conway
State/Province
Arkansas
ZIP/Postal Code
72034
Country
United States
Individual Site Status
Recruiting
Facility Name
CARTI Cancer Center
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Name
CARTI North Little Rock
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
Country
United States
Individual Site Status
Recruiting
Facility Name
CARTI Stuttgart
City
Stuttgart
State/Province
Arkansas
ZIP/Postal Code
72160
Country
United States
Individual Site Status
Recruiting
Facility Name
Pacific Cancer Medical Center INC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Individual Site Status
Recruiting
Facility Name
Beverly Hills Cancer Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Emad Ibrahim,MD,INC.
City
Redlands
State/Province
California
ZIP/Postal Code
92373
Country
United States
Individual Site Status
Recruiting
Facility Name
Providence Medical Foundation
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Care Health Services - Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Care Health Services, Helen F. Graham Cancer Center Pharmacy
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Care Hematology Oncology - Helen F Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Hematology Consultants, P A, Helen F. Graham Cancer Center
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Care Health Services - Christiana Hospital
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Name
Tallahassee Memorial HealthCare
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
TMH Cancer Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Name
IU Health Arnett Cancer Center
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Individual Site Status
Recruiting
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Individual Site Status
Recruiting
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Individual Site Status
Recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Name
Bozeman Health Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Individual Site Status
Recruiting
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Fremont
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Grand Island
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Regional
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Hematology West P.C. dba Nebraska Cancer - Methodist
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Bergan
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68124
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Hematology West P.C. dba Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Oncology Hematology West P.C. dba Nebraska Cancer - Papillion
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Regional Cancer Care Associates
City
Little Silver
State/Province
New Jersey
ZIP/Postal Code
07739
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Marion L. Shepard Cancer Center
City
Washington
State/Province
North Carolina
ZIP/Postal Code
27889
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University: Center for Health and Healing 1
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University: Center for Health and Healing 2
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Carta - Clinical Associates in Research Therapeutics of America, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Individual Site Status
Recruiting
Facility Name
Peninsula Cancer Institute
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23601
Country
United States
Individual Site Status
Recruiting
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Associates, PS (dba Summit Cancer Centers)
City
Spokane Valley
State/Province
Washington
ZIP/Postal Code
99216
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Associates, PS (dba Summit Cancer Centers)
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Oncology Associates, PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Individual Site Status
Recruiting
Facility Name
Central Washington Health Services Association d/b/a Confluence Health
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wenatchee Valley Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Name
Orange Hospital
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Individual Site Status
Recruiting
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Name
GenesisCare North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
GenesisCare North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
St Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Western Health-Sunshine & Footscray Hospitals
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Hospital for Active Treatment of Oncology - Haskovo
City
Haskovo
ZIP/Postal Code
6300
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Ruse EOOD
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Shumen
City
Shumen
ZIP/Postal Code
9700
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital for Active Treatment Serdika EOOD
City
Sofia
ZIP/Postal Code
1303
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
MHAT for Women's Health Nadezhda
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Specialized Hospital for Active Treatment of Oncology EAD
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital for Active Treatment Sofiamed
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Complex Oncology Center - Vratsa
City
Vratsa
ZIP/Postal Code
3000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
William Osler Health System
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Victoria Hospital & Children's Hospital - London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
CIUSSS- saguenay-Lac-Saint-Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
CIUSSS- saguenay-Lac-Saint-Jean
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Regional De Rimouski
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre intégré de santé et de services sociaux du Bas Saint-Laurent- Hôpital régional de Rimous
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital Tongji Medical,Science & Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213004
Country
China
Individual Site Status
Recruiting
Facility Name
Changzhou No.2 People's Hospital
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213100
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Name
Shanghai Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Name
Shanxi Provincial Cancer Hospital
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030013
Country
China
Individual Site Status
Recruiting
Facility Name
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
Individual Site Status
Recruiting
Facility Name
The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325035
Country
China
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Olomouc
City
Olomouc
State/Province
Olomoucký KRAJ
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Fakultni nemocnice Bulovka
City
Prague
State/Province
Praha 8
ZIP/Postal Code
180 81
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Res Medica s.r.o.
City
Novy Knin
State/Province
Středočeský KRAJ
ZIP/Postal Code
26203
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Oblastní nemocnice Příbram, a.s.
City
Příbram
State/Province
Středočeský KRAJ
ZIP/Postal Code
261 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Bacs-Kiskun Varmegyei Oktatokorhaz
City
Kecskemét
State/Province
Bács-kiskun
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
City
Szolnok
State/Province
Jász-nagykun-szolnok
ZIP/Postal Code
5004
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Országos Korányi Pulmonológiai Intézet
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa
State/Province
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Cancer Center
City
Akashi
State/Province
Hyogo
ZIP/Postal Code
673-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa cancer center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Aichi Cancer Center Hospital
City
Nagoya
State/Province
Nagoya, Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
Shizuoka Cancer Center
City
Nagaizumi-cho,Sunto-gun
State/Province
Shizuoka
ZIP/Postal Code
411-8777
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Foundation For Cancer Research Cancer Institute Hospital
City
Koto-Ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
University Hospital,Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
University Hospital,Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Foundation for Cancer Research
City
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Centrum Badań Klinicznych Jagiellońskie Centrum Innowacji sp. z o.o.
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
30-348
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
City
Kraków
State/Province
Małopolskie
ZIP/Postal Code
31-826
Country
Poland
Individual Site Status
Recruiting
Facility Name
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej
City
Biala Podlaska
State/Province
Podlaskie
ZIP/Postal Code
21-500
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny w Prabutach Spolka z o.o.
City
Prabuty
State/Province
Pomorskie
ZIP/Postal Code
82-550
Country
Poland
Individual Site Status
Recruiting
Facility Name
Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego
City
Grudziadz
ZIP/Postal Code
86-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ "Vegamed"
City
Katowice
ZIP/Postal Code
40-060
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczna Praktyka Lekarska Slawomir Mandziuk
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Pulmonologii i Torakochirurgii w Bystrej
City
Bystra
State/Province
Śląskie
ZIP/Postal Code
43-360
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Ruzinov
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Individual Site Status
Not yet recruiting
Facility Name
Narodny onkologicky ustav, II. Onkologicka klinika LFUK a NOU
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Specializovana nemocnica sv. Svorada Zobor, n.o.
City
Nitra
ZIP/Postal Code
949 88
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica s poliklinikou Nove Zamky
City
Nove Zamky
ZIP/Postal Code
940 34
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Nemocnica na okraji mesta, n.o.
City
Partizanske
ZIP/Postal Code
95801
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari General de Catalunya
City
Sant Cugat del Vallès
State/Province
Barcelona [barcelona]
ZIP/Postal Code
08915
Country
Spain
Individual Site Status
Recruiting
Facility Name
Institut Català d'Oncologia - L'Hospitalet
City
L'Hospitalet de Llobregat
State/Province
Catalunya [cataluña]
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Son Llàtzer
City
Palma
State/Province
Illes Balears [islas Baleares]
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundación Instituto Valenciano de Oncología
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
València
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Chi Mei Hospital - Liouying Branch
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
73657
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Koo Foundation Sun Yat-Sen Cancer Center
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation-Linkou Branch
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=C3651003
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

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