NCT04805333CompletedPhase 1
Phase 1 Dose Escalation of ArtemiCoffee
A Phase 1 Dose Escalation of ArtemiCoffee in Patients With Advanced Ovarian Cancer
Source: ClinicalTrials.gov · Last updated 10 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 16 Mar 2021
- Start date
- 26 Mar 2021
- Primary completion date
- 4 Feb 2025
- Lead sponsor
- Frederick R. Ueland, M.D.
- Diseases
- Ovarian cancer
- NCT number
- NCT04805333
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 13
- From 26 Mar 2021 to the primary completion date, 4 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of strong inducers of CYP2A6, including phenobarbital and rifampin
- 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.
Other illness
- 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.
Other
- Pregnant women are excluded from this study.
- Women with active gastric ulcers are excluded from this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.