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

1Globe Health Institute

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Other: Standard of care treatment options; Drug: GB201; Drug: Paclitaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03721744

STEMNESS-PANC

Details and patient eligibility

About

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

Enrollment: 336 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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336 participants in 2 patient groups

GB201+Paclitaxel+Gemcitabine

Experimental group

Description:

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.

Treatment:

Drug: Gemcitabine

Drug: Paclitaxel

Drug: GB201

Standard of care treatment options

Active Comparator group

Description:

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.

Treatment:

Other: Standard of care treatment options