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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03721744
• Other study ID #: STEMNESS-PANC
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 25, 2018
• Est. completion date: September 2025

Study information

• Verified date: April 2024
• Source: 1Globe Biomedical Co., Ltd.
• Contact: Shirley Yuan
• Phone: +86-15901044003
• Email: yuanning[@]1globe-china.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 336
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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
• 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. 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.

11. Uncontrolled chronic diarrhea = grade 2 at baseline.

12. Patients being treated with any coumarins.

13. Patients with a history of other malignancies.

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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
• 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
• 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.

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 country/region) or best supportive care (BSC).

Locations

Country	Name	City	State
China	Beijng Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing
China	The First Bethune Hospital of Jilin University	Changchun	Jilin
China	People's Hospital of Hunan Province	Changsha	Hunan
China	The Third Xianya Hospital of Central South University	Changsha	Hunan
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
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	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	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Hospital of Jiaxing	Jiaxing	Zhejiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	The 81 Hospital of the Chinese People Liberation Army	Nanjing	Jiangsu
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	East Hospital of Tongji University	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Huashan Hospital Fudan University	Shanghai	Shanghai
China	Shanghai General Hospital	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	Union Hospital of Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
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
France	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
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario HMN Sanchinarro	Madrid
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
1Globe Health Institute LLC

Countries where clinical trial is conducted

China,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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