Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment
Trial Parameters
Brief Summary
This is a phase 1, multi-center, open-label, dose-escalation study of nab-sirolimus in adult patients with locally advanced or metastatic solid tumors and moderate hepatic impairment or normal hepatic function.
Eligibility Criteria
Inclusion Criteria: * For All Patients 1. Willing and able to provide informed consent and comply with protocol requirements for the duration of the study. 2. Male or female patients at least 18 years of age at the time of signing the informed consent form. 3. Histologically confirmed locally advanced or metastatic solid tumors that is measurable or non-measurable. 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 5. Adequate hematologic counts: * Absolute neutrophil count (ANC) ≥1.0 × 109 /L (growth factor support allowed) * Platelet count ≥75,000/mm 3 (75 × 10 9 /L) (transfusion and/or growth factor support allowed) * Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed) 6. Creatinine clearance ≥30 mL/min as assessed by the Cockcroft-Gault equation: Creatinine Clearance ≥30 = (140 - age) × (weight\[kg\] / (72 x SCr\[mL/min\]\_ x 0.85, if female 7. Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be ≤350