Loading clinical trials...

RECRUITINGPHASE2/PHASE3

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

NCT03721744•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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Written, signed consent for trial participation in accordance with applicable ICH guidelines.
•2. Must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is metastatic.
•3. 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.
•4. Must have one or more evaluable metastatic tumors by RECIST 1.1.
•5. Must have ECOG Performance Status of 0 or 1.
•6. Must have life-expectancy of \> 12 weeks.
•7. Must be ≥ 18 years of age.
•8. For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy.
•9. Adequate biological parameters：
•* Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L
+11 more criteria

Exclusion Criteria

•1. 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.
•2. Patients with any unresolved lingering toxicity \> Grade 2 from prior treatment will be excluded.
•3. Patient who were intolerant to prior taxane treatment.
•4. Major surgery within 4 weeks prior to randomization.
•5. Patients with any known brain or leptomeningeal metastases are excluded, even if treated.
•6. Patients with clinically significant pleural effusion or ascites.
•7. Patient with gastrointestinal disorder(s) which could significantly impede the absorption of an oral agent.
•8. Prior treatment with napabucasin or participation in a clinical trial evaluating napabucasin.
•9. Uncontrolled inter-current illness.
•10. Known hypersensitivity to gemcitabine, taxanes or any of their excipients.
+3 more criteria

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

Key Dates

Start Date

October 25, 2018

Primary Completion Date

March 1, 2025

Completion Date

September 1, 2025

Last Updated

April 3, 2024

Enrollment

336

ESTIMATED participants

Conditions

Metastatic Pancreatic Cancer

Interventions

GB201

DRUG

Paclitaxel

DRUG

Gemcitabine

DRUG

Standard of care treatment options

OTHER

Contacts

Shirley Yuan

CONTACT

+86-15901044003 yuanning@1globe-china.com

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

View study

RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer