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
Recruiting · NCT06989437 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
placeboponsegromab
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 23 US states.
- The Kirklin Clinic of UAB Hospital - Birmingham, Alabama, United States
- The University of Alabama at Birmingham - Birmingham, Alabama, United States
- Mayo Clinic Hospital - Phoenix, Arizona, United States
- Central Arkansas Radiation Therapy Institute, dba CARTI - Bryant, Arkansas, United States
- Central Arkansas Radiation Therapy Institute, dba CARTI - Conway, Arkansas, United States
- CARTI Cancer Center - Little Rock, Arkansas, United States
- Central Arkansas Radiation Therapy Institute, dba CARTI - North Little Rock, Arkansas, United States
- Central Arkansas Radiation Therapy Institute, dba CARTI - Pine Bluff, Arkansas, United States
- UC San Diego Medical Center - Encinitas - Encinitas, California, United States
- Chao Family Comprehensive Cancer Center and Ambulatory Care - Irvine, California, United States
- UCI Health - Irvine - Irvine, California, United States
- UC San Diego Koman Family Outpatient Pavilion - La Jolla, California, United States
- UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion) - La Jolla, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- UC San Diego Sulpizio Cardiovascular Center - La Jolla, California, United States
- Cedars-Sinai Cancer at Cedars-Sinai Medical Center - Los Angeles, California, United States
- UCLA Department of Medicine - Hematology/Oncology - Los Angeles, California, United States
- UC Irvine Health - Orange, California, United States
- UC San Diego Medical Center - Bankers Hill - San Diego, California, United States
- UC San Diego McGrath Outpatient Pavilion - Hillcrest - San Diego, California, United States
- UC San Diego Medical Center - Hillcrest - San Diego, California, United States
- UC San Diego Medical Center - Rancho Bernardo - San Diego, California, United States
- UCLA Hematology/Oncology - Santa Monica - Santa Monica, California, United States
- Providence Medical Foundation - Santa Rosa, California, United States
- UC San Diego Medical Center - Vista - Vista, California, United States
- Georgetown University Medical Center - Department of Pharmacy, Oncology Pharmacy - Washington D.C., District of Columbia, United States
- Georgetown University Medical Center - Washington D.C., District of Columbia, United States
- Mayo Clinic Pharmacy - Jacksonville, Florida, United States
- Mayo Clinic - Jacksonville, Florida, United States
- University Cancer & Blood Center, LLC - Athens, Georgia, United States
- Invision, LLC - Honolulu, Hawaii, United States
- University of Hawaii Cancer Center - Honolulu, Hawaii, United States
- Cardiology Associates, Inc - ‘Aiea, Hawaii, United States
- Cancer Care Specialists of Illinois - Decatur, Illinois, United States
- Decatur Memorial Hospital - Decatur, Illinois, United States
- Hope and Healing Clinical Research LLC - Hinsdale, Illinois, United States
- Hope and Healing Clinical Research LLC New Lenox- Research Department - New Lenox, Illinois, United States
- Cancer Care Specialists of Illinois - Cancer Care Center of O'Fallon - O'Fallon, Illinois, United States
- United Imaging Consultants - Lenexa, Kansas, United States
- MidAmerica Cancer Care- American Oncology Partners - Merriam, Kansas, United States
- University of Kentucky Research Foundation - Lexington, Kentucky, United States
- University of Kentucky Healthcare - Markey Cancer Center - Lexington, Kentucky, United States
- University of Kentucky Medical Center - Lexington, Kentucky, United States
- University of Kentucky, Markey Cancer Center Clinical Research Office (UK MCC CRO) - Lexington, Kentucky, United States
- JHU Oncology Central Kit Services - Baltimore, Maryland, United States
- Johns Hopkins Hospital - Baltimore, Maryland, United States
- Oncology Investigational Drug Service (IDS) - Baltimore, Maryland, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore, Maryland, United States
- Mayo Clinic Cancer Center Outpatient Pharmacy - Rochester, Minnesota, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Premier Imaging - Kansas City, Missouri, United States
- St. Joseph Medical Center - Kansas City, Missouri, United States
- MidAmerica Cancer Care - American Oncology Partners - Kansas City, Missouri, United States
- Nebraska Medicine - Omaha, Nebraska, United States
- Nebraska Medicine - Village Pointe - Omaha, Nebraska, United States
- University of Nebraska Medical Center - Omaha, Nebraska, United States
- Renown Health Medical Oncology - Reno, Nevada, United States
- Renown Office of Clinical Research - Reno, Nevada, United States
- Renown Regional Medical Center - Reno, Nevada, United States
- Atlantic Health System / Morristown Medical Center - Morristown, New Jersey, United States
Showing 60 of 220 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →