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
1 other identifier
interventional
336
3 countries
38
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2018
Longer than P75 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2018
CompletedStudy Start
First participant enrolled
October 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedApril 3, 2024
April 1, 2024
6.4 years
October 25, 2018
April 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 months
Secondary Outcomes (5)
Progression free survival (PFS)
30 months
Objective response rate (ORR)
30 months
Disease control rate (DCR)
30 months
Quality of Life (QoL)
30 months
Safety by reporting the adverse events and serious adverse events
30 months
Study Arms (2)
GB201+Paclitaxel+Gemcitabine
EXPERIMENTALPatients 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.
Standard of care treatment options
ACTIVE COMPARATORPatients 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.
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- Written, signed consent for trial participation in accordance with applicable ICH guidelines.
- Must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
- Patients who are candidates for and have access to gemcitabine-nab-paclitaxel or are candidates for FOLFIRINOX/mFOLFIRINOX must have received these standard of care regimens before randomization.
- Must have one or more evaluable metastatic tumors by RECIST 1.1.
- Must have ECOG Performance Status of 0 or 1.
- Must have life-expectancy of \> 12 weeks.
- Must be ≥ 18 years of age.
- For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy.
- Adequate biological parameters：
- Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
- Platelet count ≥ 100,000/mm\^3 (100 × 10\^9/L).
- Hemoglobin (Hgb) ≥ 9 g/dL.
- AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) \[5 ×ULN in presence of liver metastases\]
- Total bilirubin ≤ 1.5 × institutional ULN. If total bilirubin is \> ULN, it must be non-rising for at least 3 days.
- Serum creatinine within normal limits or calculated clearance \> 60 mL/min/1.73 m\^2.
- +6 more criteria
You may not qualify if:
- Anti-cancer chemotherapy, radiotherapy, biologic therapy or immunotherapy administered two weeks prior to the first planned dose of study medication. Investigational agents administered within four weeks of first planned dose of study medication.
- Patients with any unresolved lingering toxicity \> Grade 2 from prior treatment will be excluded.
- Patient who were intolerant to prior taxane treatment.
- Major surgery within 4 weeks prior to randomization.
- Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
- Patients with clinically significant pleural effusion or ascites.
- Patient with gastrointestinal disorder(s) which could significantly impede the absorption of an oral agent.
- Prior treatment with napabucasin or participation in a clinical trial evaluating napabucasin.
- Uncontrolled inter-current illness.
- Known hypersensitivity to gemcitabine, taxanes or any of their excipients.
- Uncontrolled chronic diarrhea ≥ grade 2 at baseline.
- Patients being treated with any coumarins.
- Patients with a history of other malignancies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2018
First Posted
October 26, 2018
Study Start
October 25, 2018
Primary Completion
March 1, 2025
Study Completion
September 1, 2025
Last Updated
April 3, 2024
Record last verified: 2024-04