OncoMatch/Clinical Trials/NCT06953453
A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors
Is NCT06953453 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Inhaled Fentanyl Aerosol and Fentanyl Citrate for cancer.
Treatment: Inhaled Fentanyl Aerosol · Fentanyl Citrate — This study is a single-dose, open-label, 2-cycle crossover design, comparing the pharmacokinetic parameters and safety of Inhaled Fentanyl Aerosol and intravenous fentanyl injection.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: opioid (codeine, dihydrocodeine, hydromorphone, oxycodone, methadone, morphine, fentanyl, pethidine)
used opioids within 14 days before the first administration, including but not limited to: codeine, dihydrocodeine, hydromorphone, oxycodone, methadone, morphine, fentanyl and pethidine (pethidine)
Cannot have received: radiotherapy
Exception: except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable
plan to receive radiotherapy and / or systemic chemotherapy within 14 days before the first administration or during the study period (except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable)
Cannot have received: systemic chemotherapy
Exception: except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable
plan to receive radiotherapy and / or systemic chemotherapy within 14 days before the first administration or during the study period (except for patients who receive immune checkpoint inhibitors or targeted drug maintenance therapy that is not a CYP3A4 inhibitor / inducer and whose condition is stable)
Cannot have received: monoamine oxidase inhibitor (phenelzine, isocarbazine, chlorogiline, toloxadone, moclobemide, selegiline, rasagiline)
within 14 days before the first administration, the patient had received any monoamine oxidase (MAO) inhibitors (such as phenelzine, isocarbazine, chlorogiline, toloxadone, moclobemide, selegiline, rasagiline, etc.)
Lab requirements
Blood counts
ANC ≥1.5×10^9/L (no colony stimulating factor within 14 days); Platelet count ≥80×10^9/L (no transfusion or platelet-increasing drugs within 14 days); Hemoglobin ≥90g/L (no transfusion or hemoglobin-increasing drugs within 7 days)
Kidney function
Creatinine clearance rate (Ccr)≥30 ml/min, Cr≤2×ULN
Liver function
AST and ALT ≤2.5×ULN (≤5×ULN with liver metastasis); total bilirubin ≤2×ULN
Have sufficient hematopoietic function and organ function within the last 14 days at random. (see details in criteria 5.1-5.7)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify