Phase 1 Dose Escalation of ArtemiCoffee

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jill M Kolesar
• Collaborator: ArtemiLife

Criteria

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.