NCT03721744

A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer

A Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Sponsor: 1Globe Health Institute LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II/III Randomized, Open-Label Clinical Study of GB201 in Combination with Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Metastatic Pancreatic Cancer Following Chemotherapy Failure

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	GB201	GB201 will be administered orally, twice daily, with doses separated by approximately 8-12 hours. GB201 administration will begin 2-5 days prior to the first infusion of paclitaxel and low-dose gemcitabine
DRUG	Paclitaxel	Paclitaxel 80 mg/m\^2 will be administered intravenously starting on Day 1 of Cycle 1. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle
DRUG	Gemcitabine	Low-dose gemcitabine 600 mg/m\^2 will be administered intravenously following completion of paclitaxel infusion. This regimen will be repeated on Days 1, 8 and 15 of every 28-day cycle.
OTHER	Standard of care treatment options	Patients will receive one of the standard of care treatment options assigned by the Investigator for each patient prior to starting protocol treatment, including Gemcitabine, capecitabine, 5-FU/LV, Onivyde plus 5-FU/LV (if Onivyde is available in the country/region) or best supportive care (BSC).

Timeline

• Start date: 2018-10-25
• Primary completion: 2025-03-01
• Completion: 2025-09-01
• First posted: 2018-10-26
• Last updated: 2024-04-03

Locations

38 sites across 3 countries: China, France, Spain