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NOT YET RECRUITING
NCT03301805
PHASE2

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

Sponsor: Rgene Corporation

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-07-01

Completion Date

2027-06-30

Last Updated

2024-08-09

Healthy Volunteers

No

Interventions

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.