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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.
Full description
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. Eligible patients will receive nab-sirolimus by intravenous (IV) infusion over 30 minutes (+10 min) on Days 1 and 8.
Enrollment
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Inclusion criteria
For All Patients
Willing and able to provide informed consent and comply with protocol requirements for the duration of the study.
Male or female patients at least 18 years of age at the time of signing the informed consent form.
Histologically confirmed locally advanced or metastatic solid tumors that is measurable or non-measurable.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
Adequate hematologic counts:
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
Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be
≤350 mg/dL.
Male or non-pregnant and non-breastfeeding female:
Minimum of 4 weeks since major surgery, completion of radiation, or completion of all prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and in either case adequately recovered from the acute toxicities of any prior therapy (including neuropathy) to Grade ≤1. For Patients with Normal Hepatic Function
Normal hepatic function (total bilirubin ≤ upper limit of normal [ULN] and aspartate aminotransferase [AST] ≤ULN). For Patients with Moderate Hepatic Impairment
Moderate hepatic impairment (total bilirubin 1.5-3.0 × ULN and any level of AST)
Exclusion criteria
Received prior treatment with an mTOR inhibitor within 4 weeks prior to first dose.
Patients who have any severe and/or uncontrolled medical or psychiatric conditions or other conditions that could affect their participation including:
Have active severe (Grade ≥3) infection requiring intravenous (IV) antibiotics (contact medical monitor for clarification).
High-dose systemic corticosteroids (>10 mg of prednisone or its equivalent) are not permitted within 2 weeks of first dose. However, inhaled, intranasal, intra articular, and topical steroids are allowed.
Have a history of Gilbert's disease.
Any condition that in the opinion of the Investigator would place the patient at an unacceptable risk or cause the patient to be unlikely to fully participate or comply with study procedures.
For Patients with Moderate Hepatic Impairment
Had a clinical exacerbation of liver disease within the 2-week period prior to first dose (ie, abdominal pain, nausea, vomiting, anorexia, or fever).
Have clinically demonstrable, tense ascites.
Had evidence of acute viral hepatitis within 1 month prior to first dose.
Have evidence of hepatorenal syndrome.
Have a transjugular intrahepatic portosystemic shunt.
Have active stage 3 or 4 encephalopathy.
Primary purpose
Allocation
Interventional model
Masking
28 participants in 1 patient group
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Aadi Medical Information
Data sourced from clinicaltrials.gov
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