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RECRUITING
NCT03721744
PHASE2/PHASE3

A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer

Sponsor: 1Globe Health Institute LLC

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

336

Start Date

2018-10-25

Completion Date

2025-09

Last Updated

2024-04-03

Healthy Volunteers

No

Interventions

DRUG

GB201

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

DRUG

Paclitaxel

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

DRUG

Gemcitabine

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.

OTHER

Standard of care treatment options

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).

Locations (38)

Anhui Provincial Cancer Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijng Cancer Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

Guangdong General Hospital

Guangzhou, Guangdong, China

SUN YAT-SEN University Cancer Center

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital of Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

People's Hospital of Hunan Province

Changsha, Hunan, China

The Third Xianya Hospital of Central South University

Changsha, Hunan, China

The 81 Hospital of the Chinese People Liberation Army

Nanjing, Jiangsu, China

Nantong Tumor Hospital

Nantong, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

The Second Hospital of Dalian Medical University

Dalian, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

East Hospital of Tongji University

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Tianjin Medical University Cancer Institute Hospital

Tianjin, Tianjin Municipality, China

Sir Run Shaw Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

The First Affiliated Hospital Zhejiang University

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Institut de Cancerologie de Lorraine

Bourgogne, France

Unité de Recherche Clinique en Cancérologie, Institut de cancérologie et d'hématologie

Brest, France

Centre Antoine Lacassagne

Nice, France

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario HMN Sanchinarro

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain