A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma
Status: Recruiting
Location: See all (101) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Signed Informed Consent Document
• Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
• Cachexia defined by Fearon criteria of weight loss
• Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
• ECOG PS ≤1 with life expectancy of at least 4 months
Locations
United States
Alabama
The Kirklin Clinic of UAB Hospital
NOT_YET_RECRUITING
Birmingham
The University of Alabama at Birmingham
NOT_YET_RECRUITING
Birmingham
Arkansas
Central Arkansas Radiation Therapy Institute, dba CARTI
NOT_YET_RECRUITING
Bryant
Central Arkansas Radiation Therapy Institute, dba CARTI
NOT_YET_RECRUITING
Conway
CARTI Cancer Center
NOT_YET_RECRUITING
Little Rock
Central Arkansas Radiation Therapy Institute, dba CARTI
NOT_YET_RECRUITING
North Little Rock
Central Arkansas Radiation Therapy Institute, dba CARTI
NOT_YET_RECRUITING
Pine Bluff
California
Cedars-Sinai Cancer at Cedars-Sinai Medical Center
NOT_YET_RECRUITING
Los Angeles
UCLA Department of Medicine - Hematology/Oncology
NOT_YET_RECRUITING
Los Angeles
UCLA Hematology/Oncology - Santa Monica
NOT_YET_RECRUITING
Santa Monica
Providence Medical Foundation
NOT_YET_RECRUITING
Santa Rosa
Washington, D.c.
Georgetown University Medical Center
NOT_YET_RECRUITING
Washington D.c.
Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy
NOT_YET_RECRUITING
Washington D.c.
Hawaii
Cardiology Associates, Inc
RECRUITING
‘aiea
Invision, LLC
RECRUITING
Honolulu
University of Hawaii Cancer Center
RECRUITING
Honolulu
Illinois
Hope and Healing Cancer Services
NOT_YET_RECRUITING
Hinsdale
Hope and Healing Cancer Services New Lenox
NOT_YET_RECRUITING
New Lenox
Kentucky
University of Kentucky Healthcare - Markey Cancer Center
NOT_YET_RECRUITING
Lexington
University of Kentucky Medical Center
NOT_YET_RECRUITING
Lexington
University of Kentucky Research Foundation
NOT_YET_RECRUITING
Lexington
University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO)
NOT_YET_RECRUITING
Lexington
Maryland
JHU Oncology Central Kit Services
NOT_YET_RECRUITING
Baltimore
Johns Hopkins Hospital
NOT_YET_RECRUITING
Baltimore
Oncology Investigational Drug Service (IDS)
NOT_YET_RECRUITING
Baltimore
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
NOT_YET_RECRUITING
Baltimore
Nevada
Renown Health Medical Oncology
RECRUITING
Reno
Renown Office of Clinical Research
RECRUITING
Reno
Renown Regional Medical Center
RECRUITING
Reno
Oregon
OHSU Center for Health & Healing 1
NOT_YET_RECRUITING
Portland
Oregon Health and Science University
NOT_YET_RECRUITING
Portland
OSHU Center for Health and Healing 2
NOT_YET_RECRUITING
Portland
Texas
Houston Methodist Hospital
NOT_YET_RECRUITING
Houston
Washington
Virginia Mason Medical Center
NOT_YET_RECRUITING
Seattle
Other Locations
Australia
Icon Cancer Centre Hobart
RECRUITING
Hobart
ICON Cancer Centre - Kurralta Park
NOT_YET_RECRUITING
Kurralta Park
Shoalhaven District Memorial Hospital
NOT_YET_RECRUITING
Nowra
Western Health-Sunshine & Footscray Hospitals
NOT_YET_RECRUITING
St Albans
Westmead Hospital
NOT_YET_RECRUITING
Westmead
Brazil
Oncocentro
NOT_YET_RECRUITING
Belo Horizonte
Liga Norte Riograndense Contra o Câncer
NOT_YET_RECRUITING
Natal
Hospital Moinhos de Vento
NOT_YET_RECRUITING
Porto Alegre
Icesp - Instituto Do Câncer Do Estado de São Paulo
NOT_YET_RECRUITING
São Paulo
Hospital Santa Rita de Cassia
NOT_YET_RECRUITING
Vitória
Canada
CIUSSS- saguenay-Lac-Saint-Jean
RECRUITING
Chicoutimi
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
RECRUITING
Greenfield Park
Jewish General Hospital
NOT_YET_RECRUITING
Montreal
China
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
The Second Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Qilu Hospital of Shandong University
RECRUITING
Jinan
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Shanghai General Hospital
NOT_YET_RECRUITING
Shanghai
The University of Hong Kong-Shenzhen Hospital
RECRUITING
Shenzhen
The First Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
India
Chittaranjan National Cancer Institute
NOT_YET_RECRUITING
Kolkata
Tata Memorial Hospital
RECRUITING
Mumbai
Rajiv Gandhi Cancer Institute And Research Centre
NOT_YET_RECRUITING
New Delhi
Venkateshwar Hospital
NOT_YET_RECRUITING
New Delhi
Israel
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Medical Center
RECRUITING
Tel Aviv
Japan
Chiba cancer center
RECRUITING
Chiba
National Cancer Center Hospital
RECRUITING
Chuo-ku
Kyushu University Hospital
RECRUITING
Fukuoka
National Hospital Organization Kyushu Cancer Center
RECRUITING
Fukuoka
National Cancer Center Hospital East
NOT_YET_RECRUITING
Kashiwa
St. Marianna University Hospital
RECRUITING
Kawasaki
Kagawa University Hospital
RECRUITING
Kita-gun
The Cancer Institute Hospital of JFCR
RECRUITING
Koto-ku
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Shizuoka Cancer Center
NOT_YET_RECRUITING
Nagaizumi-cho
Aichi Cancer Center Hospital
RECRUITING
Nagoya
The University of Osaka Hospital
NOT_YET_RECRUITING
Suita
Yamaguchi University Hospital
RECRUITING
Ube
Wakayama Medical University Hospital
RECRUITING
Wakayama
Wakayama Minami Radiology Clinic
RECRUITING
Wakayama-shi Kimiidera 870-2
Kanagawa cancer center
RECRUITING
Yokohama
Puerto Rico
Pan American Center for Oncology Trials, LLC - Dorado Office
RECRUITING
Dorado
Pan American Center for Oncology Trials, LLC - Mayaguez Office
RECRUITING
Mayagüez
Pan American Center for Oncology Trials, LLC
RECRUITING
Rio Piedras
Pan American Center for Oncology Trials, LLC
RECRUITING
San Juan
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
Keimyung University Dongsan Hospital
RECRUITING
Daegu
Inha University Hospital
RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
RECRUITING
Seoul
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2025-10-03
Estimated Completion Date: 2029-12-10
Participants
Target number of participants: 982
Treatments
Experimental: Double-Blind ponsegromab Treatment lower dose
ponsegromab 200 mg subcutaneous injection every 4 weeks
Experimental: Double-Blind ponsegromab Treatment higher dose
ponsegromab 400 mg subcutaneous injection every 4 weeks
Placebo_comparator: Double-Blind Placebo Treatment
Match placebo subcutaneous injection every 4 weeks
Related Therapeutic Areas
Sponsors
Leads: Pfizer