RecruitingPhase 2Phase 3NCT03721744

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

Sponsor

1Globe Health Institute LLC

Enrollment

336 participants

Start Date

Oct 25, 2018

Study Type

INTERVENTIONAL

Conditions

Metastatic Pancreatic Cancer

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new drug called GB201 combined with two chemotherapy drugs (weekly paclitaxel and low-dose gemcitabine) in patients with advanced (metastatic) pancreatic cancer that has stopped responding to or progressed after standard chemotherapy treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic pancreatic adenocarcinoma (cancer that has spread), confirmed by tissue or cell sample - You have already received standard chemotherapy (such as gemcitabine-nab-paclitaxel or FOLFIRINOX) if you were eligible for it - Your cancer can be measured on scans - You are well enough to carry out daily activities (ECOG 0 or 1) - Your life expectancy is more than 12 weeks - Your blood counts and organ function meet minimum thresholds **You may NOT be eligible if...** - You have received anti-cancer treatment within the past 2–4 weeks - You have unresolved serious side effects from prior treatment - You are pregnant or planning to become pregnant - You have brain tumors or active infections - You have a serious heart condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGB201

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

DRUGPaclitaxel

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

DRUGGemcitabine

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.

OTHERStandard 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