Combination treatment for metastatic 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

This study is testing a new combination of treatments for people with metastatic pancreatic cancer who haven't responded to previous chemotherapy to see if it helps them feel better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 336 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: 1Globe Biomedical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 38 sites (Hefei, Anhui and 37 other locations)
• Trial ID: NCT03721744 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of GB201 in combination with weekly Paclitaxel and low-dose Gemcitabine in patients with metastatic pancreatic cancer who have not responded to previous chemotherapy. It is a Phase II/III randomized, open-label study designed to assess the safety and efficacy of this treatment regimen. Participants will be monitored for their response to the treatment and any adverse effects experienced during the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed advanced metastatic pancreatic adenocarcinoma who have previously received standard chemotherapy regimens.

Not a fit: Patients who have not been treated with standard chemotherapy options or those with a life expectancy of less than 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with metastatic pancreatic cancer who have limited treatment choices.

How similar studies have performed: While there have been studies on similar combinations, the specific use of GB201 in this context is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Hefei, Anhui and 37 other locations

• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (Recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Beijng Cancer Hospital — Beijing, Beijing, China (Recruiting)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (Recruiting)
• Chinese PLA General Hospital — Beijing, Beijing, China (Recruiting)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
• Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Guangdong General Hospital — Guangzhou, Guangdong, China (Recruiting)
• SUN YAT-SEN University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• The First Affiliated Hospital of Xinxiang Medical University — Xinxiang, Henan, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Union Hospital of Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• People's Hospital of Hunan Province — Changsha, Hunan, China (Recruiting)
• The Third Xianya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
• The 81 Hospital of the Chinese People Liberation Army — Nanjing, Jiangsu, China (Recruiting)
• Nantong Tumor Hospital — Nantong, Jiangsu, China (Recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• The Second Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
• Shandong Cancer Hospital — Jinan, Shandong, China (Recruiting)
• East Hospital of Tongji University — Shanghai, Shanghai, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, Shanghai, China (Recruiting)
• Huashan Hospital Fudan University — Shanghai, Shanghai, China (Recruiting)
• Shanghai General Hospital — Shanghai, Shanghai, China (Recruiting)
• Xin Hua Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
• Tianjin Medical University Cancer Institute Hospital — Tianjin, Tianjin, China (Recruiting)
• Sir Run Shaw Hospital School of Medicine Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)
• The First Hospital of Jiaxing — Jiaxing, Zhejiang, China (Recruiting)
• Institut de Cancerologie de Lorraine — Bourgogne, France (Recruiting)
• Unité de Recherche Clinique en Cancérologie, Institut de cancérologie et d'hématologie — Brest, France (Recruiting)
• Centre Antoine Lacassagne — Nice, France (Recruiting)
• Hospital Universitari Vall d'Hebron — Barcelona, Spain (Recruiting)
• Hospital Universitario HMN Sanchinarro — Madrid, Spain (Recruiting)
• Hospital Universitario La Paz — Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: Shirley Yuan

Conditions Metastatic Pancreatic Cancer; Pancreatic Cancer