A Study of GB201 in Combination With Weekly Paclitaxel and Low-dose Gemcitabine in Patients With Pancreatic Cancer
NCT ID: NCT03721744
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
336 participants
INTERVENTIONAL
2018-10-25
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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 8-12 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.
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.
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 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.
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).
Interventions
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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.
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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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1Globe Health Institute LLC
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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STEMNESS-PANC
Identifier Type: -
Identifier Source: org_study_id
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