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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: 1Globe Biomedical Co., Ltd.; 1Globe Health Institute LLC
• Treatments: Albumin-Bound Paclitaxel; Fluorouracil; Gemcitabine; Paclitaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.

• Must have at least failed first line therapy

• Has one or more metastatic tumors evaluable by CT scan with contrast (or MRI, if patient is allergic to CT contrast media) per RECIST 1.1

Exclusion Criteria:

• Anti-cancer chemotherapy or biologic therapy if administered prior to the first planned dose of chemotherapy within period of time equivalent to the usual cycle length of the regimen

• Prior taxane therapy in the neoadjuvant or adjuvant setting with progression occurring within 6 months of completion of taxane therapy; or any taxane therapy in the locally advanced or metastatic setting.

• Patient has experienced a decline in ECOG performance status between baseline visit and within 3 days prior to randomization