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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
336
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 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.
Overall survival (OS)
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.
Time frame: 30 months
Progression free survival (PFS)
Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
Time frame: 30 months
Objective response rate (ORR)
Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1
Time frame: 30 months
Disease control rate (DCR)
Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1
Time frame: 30 months
Quality of Life (QoL)
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
Time frame: 30 months
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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).
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGBeijng Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGCancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGChinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGFujian Medical University Union Hospital
Fuzhou, Fujian, China
RECRUITINGFujian Provincial Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGGuangdong General Hospital
Guangzhou, Guangdong, China
RECRUITINGSUN YAT-SEN University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGHarbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITING...and 28 more locations
Safety by reporting the adverse events and serious adverse events
Assessment of safety of GB201 by reporting of adverse events and serious adverse events.
Time frame: 30 months