Summary
This is a phase I dose-escalation study of Artemisia annua (Aa) in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel. The primary objective of this study is to determine the recommended phase II dose (RP2D) of Artemisia annua.
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Inclusion Criteria: * Able to understand and willing to sign a written informed consent document. * Age ≥ 18 years. * Patients diagnosed with Stage II-IV ovarian cancer who have completed initial first-line therapy with carboplatin and paclitaxel and achieved a complete response. * Creatinine clearance ≥ 60 mL/min * Total bilirubin ≤ 1.5 x ULN, and AST and ALT ≤ 3.0 x ULN * GOG Performance Status ≤ 2. Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study visits, in the opinion of the treating physician. * Pregnant women are excluded from this study. * Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin * Women with active gastric ulcers are excluded from this study. * Patients who are receiving concurrent maintenance therapy with a PARP inhibitor for a known hereditary recombinant deficiency (HRD) mutation. Bevacizumab maintenance therapy is allowed. * Concurrent use of nevirapine, ritonavir and strong UGT inhibitors or inducers.