A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma
Pfizer
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.
Description
A Phase 2b/3, randomized, double-blind, multicenter, multinational 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 mPDAC. The first-line chemotherapies will either be nab-paclitaxel plus gemcitabine or FOLFIRINOX (or mFOLFIRINOX). The double-blind period is followed by an optional open-label extension period. Initial enrollment will be in Phase 2b. If all eligibility criteria are met, participants will be randomized in a 1:1:1 allo…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 h…
Interventions
- Drugponsegromab
Double-Blind ponsegromab Treatment
- Drugplacebo
Double-Blind placebo Treatment
Locations (125)
- The Kirklin Clinic of UAB HospitalBirmingham, Alabama
- The University of Alabama at BirminghamBirmingham, Alabama
- Central Arkansas Radiation Therapy Institute, dba CARTIBryant, Arkansas
- Central Arkansas Radiation Therapy Institute, dba CARTIConway, Arkansas
- CARTI Cancer CenterLittle Rock, Arkansas
- Central Arkansas Radiation Therapy Institute, dba CARTINorth Little Rock, Arkansas