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Gemcitabine

Capecitabine

Paclitaxel

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Antimetabolites

Patients randomized to Arm 1 will receive GB201 in combination with weekly paclitaxel and low-dose gemcitabine, with one treatment cycle defined as 4 weeks (28 days). 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.

Paclitaxel and low-dose gemcitabine will be administered on Days 1, 8 and 15 of every 28-day cycle.

Patients randomized to Arm 2 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). Patients who have failed gemcitabine previously and were randomized to Arm 2 will not be eligible to receive gemcitabine as a treatment option.

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

GB201

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

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.

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).

Standard of care treatment options

Shirley Yuan

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

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

The primary objective of this study is to compare overall survival (OS) of patients with metastatic pancreatic adenocarcinoma treated with GB201 in combination with weekly paclitaxel and Low-dose gemcitabine versus standard of care treatment options.

Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.

Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1

Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1

European Organization for Research and Treatment of Cancer Quality of Life questionnaire（EORTC-QLQ-C30), is a self-administered cancer specific questionnaire with multi-dimensional scales. It consists of both multi-item scales and single item measures, including five functional domains, a global quality of life domain, three symptom domains, and six single items. For each domain or single item measure a linear transformation will be applied to standardize the raw score to range between 0 and 100. The endpoints in QoL analysis are the mean EORTC QLQ-C30 QoL change scores from baseline for the physical function and global health status/quality of life subscale scores. After transformation, higher scores in these two subscales mean better outcome

Assessment of safety of GB201 by reporting of adverse events and serious adverse events.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer	NCT03721744	Metastatic Panc...	GB201 Paclitaxel Gemcitabine Standard of car...	18 Years -	1Globe Biomedical Co., Ltd.
A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer	NCT03721744	Metastatic Panc...	GB201 Paclitaxel Gemcitabine Standard of car...	18 Years -	1Globe Biomedical Co., Ltd.

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