Ponsegromab in Adults With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma

What is the Purpose of this Study?

This study focuses on adults who have cachexia (a condition that causes significant unintentional weight loss and muscle wasting) and newly diagnosed metastatic pancreatic cancer (cancer that has spread from the pancreas to other parts of the body) for which they are going to receive initial chemotherapy. The purpose of the study is to evaluate how well an experimental drug called ponsegromab works and whether it might improve health and quality of life compared to a placebo (inactive substance) in patients who have cachexia and metastatic pancreatic cancer. Researchers will evaluate ponsegromab by examining changes in participants’ body weight, physical activity, symptoms, and quality of life. The study will also assess how well the drug is tolerated and its safety. Ponsegromab will be administered as subcutaneous injections (under the skin).


Eligibility

  • * 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
Show more

Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi

More about this Clinical Trial

What is the full name of this clinical trial?

C3651021: A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab Compared with Placebo both with Background First-Line Chemotherapy in Adult Participants with Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma

Study Details
Disease Type/Condition

Pancreas

Principal Investigator

Hendifar, Andrew

Co-Investigators

Arsen Osipov, Emily Kaymen, Jun Gong

Age Group

Adult

Phase

II/III

IRB Number

STUDY00004428

ClinicalTrials.gov ID

NCT06989437

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org
Study Detail
Disease Type/Condition

Pancreas

Principal Investigator

Hendifar, Andrew

Age Group

Adult

Phase

II/III

IRB Number

C3651021

ClinicalTrials.gov ID

NCT06989437

Key Eligibility
ClinicalTrials.gov

Contact
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org