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Trial intelligence / Profile preview
Albumin-bound Docetaxel in Advanced Pancreatic Cancer
NCT06492941Phase 3
Key facts
- Status
- Not yet recruiting
- Start
- Aug 2024
- Primary completion
- Apr 2026
- Modality
- Nanoparticles, Small Molecules
- Conditions
- pancreatic cancer (PC)
01
Overview
Phase 3, randomised, double-blind trial of albumin-bound docetaxel in pancreatic cancer (PC) (2 arms), sponsored by CSPC ZhongQi Pharmaceutical Technology. Primary endpoint: Overall Survival up to 2 years. Planned start Aug 2024; status: not yet recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Experimental Arm
Albumin-bound Docetaxel + Best Supportive Care
Placebo Comparator Arm
Placebo + Best Supportive Care
03
Who it enrols
Adult patients with advanced pancreatic cancer (including adenosquamous carcinoma) who have progressed on or are intolerant to prior gemcitabine-based and fluorouracil-based therapies. Patients must have ECOG 0-2 and adequate organ function.
04
Endpoints
Primary
Overall Survival
Secondary
Progression-Free Survival
Objective Response Rate
Disease Control Rate
Duration of Response
Incidence of Adverse Events and Serious Adverse Events
Pharmacokinetics
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