A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

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.

Interventions

• ponsegromab · DRUG

  Double-Blind ponsegromab Treatment

• placebo · DRUG

  Double-Blind placebo Treatment

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Key inclusion Criteria:

* 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

Key Exclusion Criteria:

* Current active reversible causes of decreased food intake
* Cachexia caused by other reasons
* Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
* Left ventricular ejection fraction \<50%
* Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
* History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
* History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
* Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
* Inadequate liver function
* Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2

Sites (220)

• The Kirklin Clinic of UAB Hospital, Birmingham, Alabama · RECRUITING
• The University of Alabama at Birmingham, Birmingham, Alabama · RECRUITING
• Mayo Clinic Hospital, Phoenix, Arizona · RECRUITING
• Central Arkansas Radiation Therapy Institute, dba CARTI, Bryant, Arkansas · RECRUITING
• Central Arkansas Radiation Therapy Institute, dba CARTI, Conway, Arkansas · RECRUITING
• CARTI Cancer Center, Little Rock, Arkansas · RECRUITING
• Central Arkansas Radiation Therapy Institute, dba CARTI, North Little Rock, Arkansas · RECRUITING
• Central Arkansas Radiation Therapy Institute, dba CARTI, Pine Bluff, Arkansas · RECRUITING
• UC San Diego Medical Center - Encinitas, Encinitas, California · RECRUITING
• Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California · RECRUITING
• UCI Health - Irvine, Irvine, California · RECRUITING
• UC San Diego Koman Family Outpatient Pavilion, La Jolla, California · RECRUITING
• UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion), La Jolla, California · RECRUITING
• UC San Diego Moores Cancer Center, La Jolla, California · RECRUITING
• UC San Diego Sulpizio Cardiovascular Center, La Jolla, California · RECRUITING
• Cedars-Sinai Cancer at Cedars-Sinai Medical Center, Los Angeles, California · RECRUITING
• UCLA Department of Medicine - Hematology/Oncology, Los Angeles, California · RECRUITING
• UC Irvine Health, Orange, California · RECRUITING
• UC San Diego Medical Center - Bankers Hill, San Diego, California · RECRUITING
• UC San Diego McGrath Outpatient Pavilion - Hillcrest, San Diego, California · RECRUITING
• UC San Diego Medical Center - Hillcrest, San Diego, California · RECRUITING
• UC San Diego Medical Center - Rancho Bernardo, San Diego, California · RECRUITING
• UCLA Hematology/Oncology - Santa Monica, Santa Monica, California · RECRUITING
• Providence Medical Foundation, Santa Rosa, California · RECRUITING
• UC San Diego Medical Center - Vista, Vista, California · RECRUITING
• Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy, Washington D.C., District of Columbia · RECRUITING
• Georgetown University Medical Center, Washington D.C., District of Columbia · RECRUITING
• Mayo Clinic Pharmacy, Jacksonville, Florida · RECRUITING
• Mayo Clinic, Jacksonville, Florida · RECRUITING
• University Cancer & Blood Center, LLC, Athens, Georgia · RECRUITING
• Invision, LLC, Honolulu, Hawaii · RECRUITING
• University of Hawaii Cancer Center, Honolulu, Hawaii · RECRUITING
• Cardiology Associates, Inc, ‘Aiea, Hawaii · RECRUITING
• Cancer Care Specialists of Illinois, Decatur, Illinois · RECRUITING
• Decatur Memorial Hospital, Decatur, Illinois · RECRUITING
• Hope and Healing Clinical Research LLC, Hinsdale, Illinois · RECRUITING
• Hope and Healing Clinical Research LLC New Lenox- Research Department, New Lenox, Illinois · RECRUITING
• Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon, O'Fallon, Illinois · RECRUITING
• United Imaging Consultants, Lenexa, Kansas · RECRUITING
• MidAmerica Cancer Care- American Oncology Partners, Merriam, Kansas · RECRUITING
• University of Kentucky Research Foundation, Lexington, Kentucky · RECRUITING
• University of Kentucky Healthcare - Markey Cancer Center, Lexington, Kentucky · RECRUITING
• University of Kentucky Medical Center, Lexington, Kentucky · RECRUITING
• University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO), Lexington, Kentucky · RECRUITING
• JHU Oncology Central Kit Services, Baltimore, Maryland · RECRUITING
• Johns Hopkins Hospital, Baltimore, Maryland · RECRUITING
• Oncology Investigational Drug Service (IDS), Baltimore, Maryland · RECRUITING
• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland · RECRUITING
• Mayo Clinic Cancer Center Outpatient Pharmacy, Rochester, Minnesota · RECRUITING
• Mayo Clinic, Rochester, Minnesota · RECRUITING
• Premier Imaging, Kansas City, Missouri · RECRUITING
• St. Joseph Medical Center, Kansas City, Missouri · RECRUITING
• MidAmerica Cancer Care - American Oncology Partners, Kansas City, Missouri · RECRUITING
• Nebraska Medicine, Omaha, Nebraska · RECRUITING
• Nebraska Medicine - Village Pointe, Omaha, Nebraska · RECRUITING
• University of Nebraska Medical Center, Omaha, Nebraska · RECRUITING
• Renown Health Medical Oncology, Reno, Nevada · RECRUITING
• Renown Office of Clinical Research, Reno, Nevada · RECRUITING
• Renown Regional Medical Center, Reno, Nevada · RECRUITING
• Atlantic Health System / Morristown Medical Center, Morristown, New Jersey · RECRUITING
• Jack & Sheryl Morris Cancer Center, New Brunswick, New Jersey · RECRUITING
• Rutgers Cancer Institute, New Brunswick, New Jersey · RECRUITING
• RWJ University Hospital Somerset, Steeplechase Cancer Center, Somerville, New Jersey · RECRUITING
• Rwj University Hospital Somerset, Somerville, New Jersey · RECRUITING
• Atlantic Health System / Overlook Medical Center, Summit, New Jersey · RECRUITING
• Icahn School of Medicine at Mount Sinai, New York, New York · RECRUITING
• University of Rochester Medical Center, Rochester, New York · RECRUITING
• UNC Hospitals, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina · RECRUITING
• Levine Cancer Institute, Charlotte, North Carolina · NOT_YET_RECRUITING
• University of North Carolina Hospitals at Hillsborough, Hillsborough, North Carolina · RECRUITING
• OHSU Center for Health & Healing 1, Portland, Oregon · RECRUITING
• Oregon Health and Science University, Portland, Oregon · RECRUITING
• OSHU Center for Health and Healing 2, Portland, Oregon · RECRUITING
• University of Texas Southwestern Medical Center - Simmons Cancer Center, Dallas, Texas · RECRUITING
• University of Texas Southwestern Medical Center-William P. Clements Jr. University Hospital, Dallas, Texas · RECRUITING
• University of Texas Southwestern Medical Center-Zale Lipshy University Hospital, Dallas, Texas · RECRUITING
• University of Texas Southwestern Medical Center, Dallas, Texas · RECRUITING
• Houston Methodist Hospital, Houston, Texas · RECRUITING
• Baylor Scott & White Vasicek Cancer Treatment Center, Temple, Texas · RECRUITING
• Virginia Mason Medical Center, Seattle, Washington · RECRUITING
• Fred Hutchinson Cancer Center, Seattle, Washington · RECRUITING
• University of Washington Medical Center, Seattle, Washington · RECRUITING
• Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin · RECRUITING
• Shoalhaven District Memorial Hospital, Nowra, New South Wales, Australia · RECRUITING
• Westmead Hospital, Westmead, New South Wales, Australia · RECRUITING
• ICON Cancer Centre - Kurralta Park, Kurralta Park, South Australia, Australia · RECRUITING
• Icon Cancer Centre Hobart, Hobart, Tasmania, Australia · RECRUITING
• Western Health-Sunshine & Footscray Hospitals, St Albans, Victoria, Australia · RECRUITING
• AZ Turnhout - Campus Sint-Elizabeth, Turnhout, Antwerpen, Belgium · RECRUITING
• Cliniques universitaires Saint-Luc, Brussels, Bruxelles-capitale, Région de, Belgium · RECRUITING
• Grand Hôpital de Charleroi, Charleroi, Hainaut, Belgium · RECRUITING
• UZ Leuven, Leuven, Vlaams-brabant, Belgium · RECRUITING
• Institut Jules Bordet, Brussels, Belgium · NOT_YET_RECRUITING
• Hospital Santa Rita de Cassia, Vitória, Espírito Santo, Brazil · RECRUITING
• Oncocentro, Belo Horizonte, Minas Gerais, Brazil · RECRUITING
• Liga Norte Riograndense Contra o Câncer, Natal, Rio Grande do Norte, Brazil · RECRUITING
• Hospital Moinhos de Vento, Porto Alegre, Rio Grande do Sul, Brazil · RECRUITING
• Icesp - Instituto Do Câncer Do Estado de São Paulo, São Paulo, Brazil · RECRUITING
• Medical Center Futuremeds, Plovdiv, Bulgaria · RECRUITING
• MHAT for Women's Health Nadezhda, Sofia, Bulgaria · RECRUITING
• MHAT - Sveta Sofia EOOD, Sofia, Bulgaria · RECRUITING
• University Multiprofile Hospital for Active Treatment Sofiamed, Sofia, Bulgaria · RECRUITING
• Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Alberta, Canada · RECRUITING
• The Ottawa Hospital - General Campus, Ottawa, Ontario, Canada · RECRUITING
• Sunnybrook Research Institute, Toronto, Ontario, Canada · RECRUITING
• Unity Health Toronto, St. Michael's Hospital, Toronto, Ontario, Canada · RECRUITING
• Princess Margaret Cancer Centre - University Health Network, Toronto, Ontario, Canada · RECRUITING
• CIUSSS- saguenay-Lac-Saint-Jean, Chicoutimi, Quebec, Canada · RECRUITING
• Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre, Greenfield Park, Quebec, Canada · RECRUITING
• Jewish General Hospital, Montreal, Quebec, Canada · RECRUITING
• Anhui Provincial Hospital, Hefei, Anhui, China · RECRUITING
• Cancer Hospital Chinese Academy of Medical Science, Beijing, Beijing Municipality, China · RECRUITING
• Peking Union Medical College Hospital, Beijing, Beijing Municipality, China · RECRUITING
• Fujian Cancer Hospital, Fuzhou, Fujian, China · RECRUITING
• Second Hospital of Lanzhou University, Lanzhou, Gansu, China · RECRUITING
• Guangdong General Hospital, Guangzhou, Guangdong, China · RECRUITING
• The University of Hong Kong-Shenzhen Hospital, Shenzhen, Guangdong, China · RECRUITING
• Affiliated Hospital of Hebei University, Baoding, Hebei, China · RECRUITING
• Cancer Hospital Chinese Academy of Medical Science, Langfang, Hebei, China · RECRUITING
• The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China · RECRUITING
• The Second Hospital of Dalian Medical University, Dalian, Liaoning, China · RECRUITING
• The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China · RECRUITING
• Qilu Hospital of Shandong University, Jinan, Shandong, China · RECRUITING
• Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China · RECRUITING
• The First Hospital of Shanxi Medical University, Taiyuan, Shanxi, China · RECRUITING
• Sir Run Run Shaw Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China · RECRUITING
• Huzhou Central Hospital, Huzhou, Zhejiang, China · RECRUITING
• The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China · RECRUITING
• Beijing Tsinghua Changgung Hospital, Beijing, China · RECRUITING
• Zhongshan Hospital Fudan University, Shanghai, China · RECRUITING
• Shanghai General Hospital, Shanghai, China · RECRUITING
• Institut Paoli-Calmettes, Marseille, Provence-Alpes-Côte d'Azur Region, France · RECRUITING
• Henri Mondor Hospital, Créteil, Val-de-marne, France · RECRUITING
• Gustave Roussy, Villejuif, Val-de-marne, France · NOT_YET_RECRUITING
• Centre Hospitalier Universitaire de Poitiers, Poitiers, Vienne, France · RECRUITING
• Hôpital Universitaire Paul Brousse, Villejuif, France · RECRUITING
• Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie, München, Bavaria, Germany · NOT_YET_RECRUITING
• Universitaetsklinikum Duesseldorf, Düsseldorf, North Rhine-Westphalia, Germany · RECRUITING
• Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden, Dresden, Saxony, Germany · NOT_YET_RECRUITING
• Apotheke am Universitätsklinikum Leipzig, Leipzig, Saxony, Germany · NOT_YET_RECRUITING
• Klinik und Poliklinik für Diagnostische und Interventionelle Radiologie, Leipzig, Saxony, Germany · NOT_YET_RECRUITING
• Universität Leipzig - Med. Fakultät, Leipzig, Saxony, Germany · NOT_YET_RECRUITING
• Sana Klinikum Lichtenberg, Berlin, Germany · NOT_YET_RECRUITING
• Klinikum rechts der Isar der Technischen Universität München, München, Germany · NOT_YET_RECRUITING
• Tata Memorial Hospital, Mumbai, Maharashtra, India · RECRUITING
• Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi, National Capital Territory of Delhi, India · NOT_YET_RECRUITING
• Venkateshwar Hospital, New Delhi, National Capital Territory of Delhi, India · RECRUITING
• Rajiv Gandhi Cancer Institute And Research Centre, New Delhi, National Capital Territory of Delhi, India · RECRUITING
• Sawai Man Singh Medical College Hospital (SMS Hospital), Jaipur, Rajasthan, India · RECRUITING
• Chittaranjan National Cancer Institute, Kolkata, West Bengal, India · RECRUITING
• Rabin Medical Center, Petah Tikva, Central District, Israel · RECRUITING
• Sheba Medical Center, Ramat Gan, Central District, Israel · RECRUITING
• Rambam Health Care Campus, Haifa, Heifa, Israel · RECRUITING
• Shaare Zedek Medical Center, Jerusalem, Jerusalem, Israel · RECRUITING
• Hadassah Medical Center, Jerusalem, Jerusalem, Israel · RECRUITING
• Sourasky Medical Center, Tel Aviv, TELL ABĪB, Israel · RECRUITING
• Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Milan, Italy · RECRUITING
• Azienda Ospedaliera Universitaria Careggi, Florence, Tuscany, Italy · RECRUITING
• Azienda Ospedaliero Universitaria delle Marche, Ancona, Italy · RECRUITING
• Azienda Ospedaliera Universitaria Ospedali Riuniti - Foggia, Foggia, Italy · RECRUITING
• Aichi Cancer Center Hospital, Nagoya, Aichi-ken, Japan · RECRUITING
• Chiba cancer center, Chiba, Chiba, Japan · RECRUITING
• National Cancer Center Hospital East, Kashiwa, Chiba, Japan · RECRUITING
• Kagawa University Hospital, Kita-gun, Kagawa-ken, Japan · RECRUITING
• St. Marianna University Hospital, Kawasaki, Kanagawa, Japan · RECRUITING
• Kanagawa cancer center, Yokohama, Kanagawa, Japan · RECRUITING
• The University of Osaka Hospital, Suita, Osaka, Japan · RECRUITING
• Shizuoka Cancer Center, Nagaizumi-cho, Shizuoka, Japan · RECRUITING
• National Cancer Center Hospital, Chuo-ku, Tokyo, Japan · RECRUITING
• The Cancer Institute Hospital of JFCR, Koto-ku, Tokyo, Japan · RECRUITING
• Wakayama Minami Radiology Clinic, Wakayama-shi Kimiidera 870-2, Wakayama, Japan · RECRUITING
• Yamaguchi University Hospital, Ube, Yamaguchi, Japan · RECRUITING
• National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan · RECRUITING
• Kyushu University Hospital, Fukuoka, Japan · RECRUITING
• University Hospital,Kyoto Prefectural University of Medicine, Kyoto, Japan · RECRUITING
• Wakayama Medical University Hospital, Wakayama, Japan · RECRUITING
• Centro de Investigacion Clinica de Oaxaca, Oaxaca City, Oaxaca, Mexico · RECRUITING
• Centro de Atención e Investigación Cardiovascular del Potosí S.C., San Luis Potosí City, Mexico · RECRUITING
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie, Warsaw, Masovian Voivodeship, Poland · RECRUITING
• Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko - Mazurskim Centrum Onkologii w Olsztynie, Olsztyn, Warmian-Masurian Voivodeship, Poland · RECRUITING
• Szpital Wojewódzki im. Mikołaja Kopernika w Koszalinie, Koszalin, Poland · RECRUITING
• Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, Poland · RECRUITING
• Specjalistyczny Szpital Onkologiczny NU-MED Sp. z o.o., Tomaszów Mazowiecki, Poland · RECRUITING
• Pan American Center for Oncology Trials, LLC - Dorado Office, Dorado, Puerto Rico · RECRUITING
• Pan American Center for Oncology Trials, LLC - Mayaguez Office, Mayagüez, Puerto Rico · RECRUITING
• Pan American Center for Oncology Trials, LLC, Rio Piedras, Puerto Rico · RECRUITING
• Pan American Center for Oncology Trials, LLC, San Juan, Puerto Rico · RECRUITING
• Fakultna nemocnica Trencin, Trenčín, Trenčín Region, Slovakia · RECRUITING
• Narodny onkologicky ustav, Bratislava, Slovakia · RECRUITING
• Vychodoslovensky Onkologicky Ustav a.s., Košice, Slovakia · RECRUITING
• Nemocnica s poliklinikou Stefana Kukuru Michalovce, a.s., Michalovce, Slovakia · RECRUITING
• Fakultna nemocnica s poliklinikou Nove Zamky, Nové Zámky, Slovakia · RECRUITING
• Fakultna nemocnica Trnava, Trnava, Slovakia · RECRUITING
• Inha University Hospital, Incheon, Incheon-gwangyeoksi [incheon], South Korea · RECRUITING
• Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, South Korea · RECRUITING
• CHA Bundang Medical Center, CHA University, Seongnam-si, Kyǒnggi-do, South Korea · RECRUITING
• Asan Medical Center, Seoul, Seoul Teukbyeolsi, South Korea · RECRUITING
• Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [seoul], South Korea · RECRUITING
• Severance Hospital, Yonsei University Health System, Seoul, Seoul-teukbyeolsi [seoul], South Korea · RECRUITING
• Samsung Medical Center, Seoul, Seoul-teukbyeolsi [seoul], South Korea · RECRUITING
• The Catholic Univ. of Korea Seoul St. Mary's Hospital, Seoul, Seoul-teukbyeolsi [seoul], South Korea · RECRUITING
• Keimyung University Dongsan Hospital, Daegu, Taegu-kwangyǒkshi, South Korea · RECRUITING
• Inje University Haeundae Paik Hospital, Busan, South Korea · RECRUITING
• Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [barcelona], Spain · RECRUITING
• Hospital Clínic de Barcelona, Barcelona, Catalunya [cataluña], Spain · RECRUITING
• Hospital Universitario Ramón y Cajal, Madrid, Madrid, Comunidad de, Spain · RECRUITING
• Hospital General Universitario Gregorio Marañon, Madrid, Spain · RECRUITING
• H.R.U Málaga - Hospital General, Málaga, Spain · RECRUITING
• Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City, Taiwan · RECRUITING
• China Medical University Hospital, Taichung, Taiwan · RECRUITING
• National Cheng Kung University Hospital, Tainan, Taiwan · RECRUITING
• National Taiwan University Hospital, Taipei, Taiwan · RECRUITING
• Taipei Veterans General Hospital, Taipei, Taiwan · RECRUITING
• Addenbrooke's Hospital, Cambridge, Cambridgeshire, United Kingdom · RECRUITING
• Royal Free Hospital, London, England, United Kingdom · RECRUITING
• Western General Hospital, Edinburgh, Midlothian, United Kingdom · RECRUITING
• The Clatterbridge Cancer Centre, Liverpool, United Kingdom · RECRUITING
• Guy's & St Thomas' NHS Foundation Trust, London, United Kingdom · RECRUITING
• Royal Marsden Hospital (Chelsea), London, United Kingdom · RECRUITING
• Hammersmith Hospital, London, United Kingdom · RECRUITING