Status:
COMPLETED
Phase 1 Dose Escalation of ArtemiCoffee
Lead Sponsor:
Frederick R. Ueland, M.D.
Collaborating Sponsors:
ArtemiLife
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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 objecti...
Detailed Description
This is a phase I dose-escalation study of Artemisia annua (Aa) decaffeinated coffee in patients with advanced ovarian cancer who have completed front-line chemotherapy with carboplatin and paclitaxel...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 4 2025
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04805333
Start Date
March 26 2021
End Date
February 4 2025
Last Update
February 10 2025
Active Locations (1)
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1
University of Kentucky
Lexington, Kentucky, United States, 40536