A Study Of GB201 In Combination With Weekly Paclitaxel And Low-dose Gemcitabine In Patients With Pancreatic Cancer

Study Overview

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

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

N/A

Metastatic Pancreatic Cancer

DRUG: GB201
DRUG: Paclitaxel
DRUG: Gemcitabine
OTHER: Standard of care treatment options

STEMNESS-PANC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-10-25	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-04-01
First Submitted that Met QC Criteria 2018-10-25	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-04-03
First Posted (ACTUAL) 2018-10-26	Results First Posted N/A	Last Verified 2024-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: GB201+Paclitaxel+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-	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.
ACTIVE_COMPARATOR: 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	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 coun

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: GB201+Paclitaxel+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-

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.

ACTIVE_COMPARATOR: 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

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 coun

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Progression free survival (PFS)	Defined as the time from randomization to the first objective documentation of disease progression or death due to any cause.	30 months
Objective response rate (ORR)	Defined as the proportion of patients with a documented complete response or partial response (CR + PR) based on RECIST 1.1	30 months
Disease control rate (DCR)	Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1	30 months
Quality of Life (QoL)	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	30 months
Safety by reporting the adverse events and serious adverse events	Assessment of safety of GB201 by reporting of adverse events and serious adverse events.	30 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Shirley Yuan

Phone Number: +86-15901044003

Email: yuanning@1globe-china.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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. 10. Acceptable coagulation studies. 11. No clinically significant abnormalities on urinalysis. 12. Patient must have adequate nutritional status. 13. Pain symptoms should be stable (of tolerable Grade 2 or less). 14. Only patients with available archival tumor tissue must consent to submit block of tumor tissue. 15. The patient is not receiving therapy in a concurrent clinical study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

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