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Certepetide in metastatic pancreatic cancer (China)
NCT05052567Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2021
- Primary completion
- Jun 2024
- Countries
- 1
- Sponsor
- Qilu Pharmaceutical
- Modality
- Cyclic Peptides
- Drugs
- certepetide
- Conditions
- pancreatic ductal adenocarcinoma (PDAC)
01
Overview
Phase 2, open-label, single-arm trial of certepetide in pancreatic ductal adenocarcinoma (PDAC), sponsored by Qilu Pharmaceutical. Primary endpoints: Adverse Events and Serious Adverse Events at 12 months, Objective Response Rate at 12 months and 5 more. Started Oct 2021; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
CEND-1 + Gem/Nab-Pac
CEND-1 administered in combination with paclitaxel (albumin-bound) and gemcitabine.
03
Who it enrols
Adult patients (18-80) with histologically confirmed metastatic pancreatic ductal adenocarcinoma suitable for first-line gemcitabine/nab-paclitaxel, ECOG 0-1, and life expectancy >= 12 weeks. Excludes prior systemic anti-cancer therapy for pancreatic cancer, symptomatic CNS metastases, and active HIV/Hepatitis.
04
Endpoints
Primary
Adverse Events and Serious Adverse Events
Objective Response Rate
Duration of Response
Disease Control Rate
Overall Survival
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