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OncoMatch/Clinical Trials/NCT03721744

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

Is NCT03721744 recruiting? Yes, currently enrolling (May 2026). This Phase 2/3 trial studies multiple treatments including GB201 and Paclitaxel for metastatic pancreatic cancer.

Phase 2/3Recruiting1Globe Health Institute LLCNCT03721744Data as of May 2026

Treatment: GB201 · Paclitaxel · GemcitabineThis 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

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: gemcitabine-nab-paclitaxel (gemcitabine, nab-paclitaxel) — standard of care

Patients who are candidates for and have access to gemcitabine-nab-paclitaxel ... must have received these standard of care regimens before randomization.

Must have received: FOLFIRINOX or mFOLFIRINOX (FOLFIRINOX, mFOLFIRINOX) — standard of care

or are candidates for FOLFIRINOX/mFOLFIRINOX must have received these standard of care regimens before randomization.

Cannot have received: anti-cancer chemotherapy, radiotherapy, biologic therapy or immunotherapy

Exception: allowed if completed >2 weeks prior to first planned dose of study medication

Anti-cancer chemotherapy, radiotherapy, biologic therapy or immunotherapy administered two weeks prior to the first planned dose of study medication.

Cannot have received: investigational agent

Exception: allowed if completed >4 weeks prior to first planned dose of study medication

Investigational agents administered within four weeks of first planned dose of study medication.

Cannot have received: taxane

Exception: patients intolerant to prior taxane treatment are excluded

Patient who were intolerant to prior taxane treatment.

Cannot have received: napabucasin (napabucasin)

Prior treatment with napabucasin or participation in a clinical trial evaluating napabucasin.

Lab requirements

Blood counts

Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L; Platelet count ≥ 100,000/mm^3 (100 × 10^9/L); Hemoglobin (Hgb) ≥ 9 g/dL.

Kidney function

Serum creatinine within normal limits or calculated clearance > 60 mL/min/1.73 m^2.

Liver function

AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional 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.

Adequate biological parameters: ANC ≥ 1.5 × 10^9/L; Platelet count ≥ 100,000/mm^3; Hemoglobin (Hgb) ≥ 9 g/dL; AST (SGOT) and ALT (SGPT) ≤ 2.5 × institutional 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.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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