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New treatment option for Cachexia
Official title 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
ClinicalTrials.gov ID: NCT06989437
What this study is testing
What is ponsegromab?
ponsegromab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for cachexia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- ECOG PS ≤1 with life expectancy of at least 4 months Key
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Bryant, Arkansas, United States
- Conway, Arkansas, United States
- Little Rock, Arkansas, United States
- North Little Rock, Arkansas, United States
- Pine Bluff, Arkansas, United States
- Encinitas, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Santa Rosa, California, United States
- Vista, California, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Athens, Georgia, United States
- Honolulu, Hawaii, United States
+ 142 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Bryant, Arkansas, United States; Conway, Arkansas, United States; Little Rock, Arkansas, United States; North Little Rock, Arkansas, United States and 156 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.