*Cachexia *Metastatic Pancreatic Ductal Adenocarcinoma
Conditions
Interventions
*Drug: ponsegromab
-Double-Blind ponsegromab Treatment
*Drug: placebo
-Double-Blind placebo Treatment
Sponsors
Kawai Norisuke
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: *Current active reversible causes of decreased food intake *Cachexia caused by other reasons *History of heart failure *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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| *Percent change from baseline in body weight for ponsegromab compared to placebo [Time Frame: Baseline, Week 12] *Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores [Time Frame: Baseline, Week 12] -Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome. | — |
Secondary
| Measure | Time frame |
|---|---|
| *Change from baseline in non-sedentary physical activity time [Time Frame: Baseline, Week 12] -measured by wearable Digital Health Technology watch *Overall survival [Time Frame: Randomization through completion of Phase 3 of the study, an average of 1 year] -Outcome defined as the time from randomization to occurrence of all-cause death *Change from baseline in body weight (kg) [Time Frame: Baseline, Week 12 and up to Week 52] *Change from baseline at Week 12 in physical activity as measured by total vector magnitude [Time Frame: Baseline, Week 12] -measured by wearable Digital Health Technology watch *Effect on progression free survival [Time Frame: Randomization through completion of Phase 3 of the study, an average of 1 year] -determined by Blinded Independent Central Review *Effect on objective response rate [Time Frame: Baseline, Week 52] -determined by Blinded Independent Central Review *Effect on disease control rate [Time Frame: Baseline, Week 52] -determined by Blinded Independent Central Review *Effect on duration of response [Time Frame: Baseline, Week 52] -determined by Blinded Independent Central Review *Change from baseline in skeletal muscle area and radiodensity at third lumbar vertebra (L3) [Time Frame: Baseline, Week 12] -measured by CT (or MRI) scan *Change from baseline in intermuscular adipose area and radiodensity at L3 [Time Frame: Baseline, Week 12] -measured by CT (or MRI) scan *Change from baseline in subcutaneous adipose area and radiodensity at L3 [Time Frame: Baseline, Week 12] -measured by CT (or MRI) scan *Change from baseline in visceral adipose area and radiodensity at L3 [Time Frame: Baseline, Week 12] -measured by CT (or MRI) scan *Number of participants with incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to permanent discontinuation from study intervention or from study. [Time Frame: Baseline, Week 12 and up to Week 52] *Number of participants with laborator | — |
Countries
Japan, US
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed