A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
- Conditions
- Metastatic Pancreatic Cancer
- Interventions
- Registration Number
- NCT03721744
- Lead Sponsor
- 1Globe Health Institute LLC
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 336
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of care treatment options Standard of care treatment options 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+Paclitaxel+Gemcitabine GB201 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. GB201+Paclitaxel+Gemcitabine Paclitaxel 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. GB201+Paclitaxel+Gemcitabine Gemcitabine 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.
- Primary Outcome Measures
Name Time Method Overall survival (OS) 30 months 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.
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) 30 months Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1
Safety by reporting the adverse events and serious adverse events 30 months Assessment of safety of GB201 by reporting of adverse events and serious adverse events.
Progression free survival (PFS) 30 months Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.
Objective response rate (ORR) 30 months Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1
Quality of Life (QoL) 30 months 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
Trial Locations
- Locations (38)
Institut de Cancerologie de Lorraine
🇫🇷Bourgogne, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hospital Universitario HMN Sanchinarro
🇪🇸Madrid, Spain
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
Unité de Recherche Clinique en Cancérologie, Institut de cancérologie et d'hématologie
🇫🇷Brest, France
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
The 81 Hospital of the Chinese People Liberation Army
🇨🇳Nanjing, Jiangsu, China
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Anhui Provincial Cancer Hospital
🇨🇳Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Beijng Cancer Hospital
🇨🇳Beijing, Beijing, China
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, 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 Second Hospital of Dalian Medical University
🇨🇳Dalian, Liaoning, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
People's Hospital of Hunan Province
🇨🇳Changsha, Hunan, China
The Third Xianya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shanghai General Hospital
🇨🇳Shanghai, Shanghai, China
Huashan Hospital Fudan University
🇨🇳Shanghai, Shanghai, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
East Hospital of Tongji University
🇨🇳Shanghai, Shanghai, China
Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
Tianjin Medical University Cancer Institute Hospital
🇨🇳Tianjin, Tianjin, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Sir Run Shaw Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
🇨🇳Jiaxing, Zhejiang, China