OncoMatch/Clinical Trials/NCT05064618
Investigator-initiated Clinical Trial of MIKE-1
Is NCT05064618 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Am80 and Gemcitabine for pancreatic cancer.
Treatment: Am80 · Gemcitabine · nab-Paclitaxel — To evaluate the safety and tolerability of Am80（Generic name: Tamibarotene, Development code: MIKE-1） in combination with gemcitabine (GEM) and nab-paclitaxel (nab-PTX) in patients with unresectable pancreatic cancer and to determine the recommended dose. Efficacy will also be exploratively investigated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Pancreatic Cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: other clinical trial drugs or products (excluding existing chemotherapeutic agents and placebo drugs)
Patients who have received other clinical trial drugs or products (excluding existing chemotherapeutic agents and placebo drugs) within 4 weeks before enrolment.
Lab requirements
Blood counts
White blood cell count ≥ 3,500/mm3, ≤ 12,000/mm3; Neutrophils ≥ 1,500/mm3; Platelet count ≥ 100,000/mm3; Hemoglobin ≥ 9.0g/dL; Prothrombin activity level ≥ 70%
Kidney function
Creatinine ≤ 1.5 mg/dL or Creatinine clearance ≥ 60ml/min
Liver function
Total bilirubin ≤ ULN x 1.5 (≤ 3.0 mg/dL for patients undergoing ERBD or PTBD); AST (GOT) and ALT (GPT) ≤ ULN × 3 (≤ ULN × 5 if abnormal liver function due to malignancy)
Patients who meet the following criteria in blood tests within 7 days before enrollment and whose organ functions are preserved ... (see above for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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