NCT03301805

A Phase II, EvaluateBLEX 404 Combined With Gemcitabine Monotherapy With Pancreatic Cancer

A Phase II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined With Gemcitabine Monotherapy in Patients With Advanced Inoperable or Metastatic Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Rgene Corporation · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to determine the safety and recommended dose level (RDL) of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy in a 28-day schedule.The secondary purpose is to assess the efficacy and safety of BLEX 404 Oral Liquid combined with Gemcitabine monotherapy at the recommended dose.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	BLEX 404	BLEX 404 Oral Liquid is administered twice daily during the Gemcitabine monotherapy period. The dose of Gemcitabine 1,000 mg/m2 IV fusion at Day 1, 8, 15 of every cycle * 28 days a cycle.

Timeline

• Start date: 2025-07-01
• Primary completion: 2027-04-30
• Completion: 2027-06-30
• First posted: 2017-10-04
• Last updated: 2024-08-09

Regulatory

• FDA-regulated drug study