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NCT04805333 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Dose Escalation of ArtemiCoffee
A Phase 1 study of Ovarian Cancer, sponsored by Frederick R. Ueland, M.D..
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04805333: Completed Phase 1 study of Ovarian Cancer, sponsored by Frederick R. Ueland, M.D..
NCT04805333 is a Phase 1 study of Ovarian Cancer that has completed, run by Frederick R. Ueland, M.D.. The registered enrollment target is 13 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04805333, a Phase 1 study of Ovarian Cancer, has completed, sponsored by Frederick R. Ueland, M.D..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
This study will determine the recommended phase II dose of Artemisia annua decaffeinated coffee. Once the dose escalation is finished or 12 patients are evaluated for the dose-limiting toxicity (DLT), the final recommended phase II dose will be determined by isotonic regression to pool the DLT information across all dose levels.
Conditions Studied
Interventions
- DRUG Artemisia annua 450mg
- DRUG Artemisia annua 900mg
- DRUG Artemisia annua 1350mg
- DRUG Artemisia annua 1800mg
- DRUG Artemisia annua - recommended phase II dose
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2021-03-26 |
| Est. Completion | 2025-02-04 |
| Phase | Phase 1 |
What the finished NCT04805333 record still lists
NCT04805333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Ovarian Cancer appearing as the primary indexed condition, and to 5 interventions - of which Artemisia annua 450mg is the first listed.
NCT04805333 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT04805333 about?
NCT04805333 is a clinical study titled "Phase 1 Dose Escalation of ArtemiCoffee". 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.
What is the current status of trial NCT04805333?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2021-03-26. Estimated completion is 2025-02-04.
What conditions does trial NCT04805333 study?
This clinical trial studies the following conditions: Ovarian Cancer.
What interventions are being tested in trial NCT04805333?
The interventions under investigation include: Artemisia annua 450mg (DRUG), Artemisia annua 900mg (DRUG), Artemisia annua 1350mg (DRUG), Artemisia annua 1800mg (DRUG), Artemisia annua - recommended phase II dose (DRUG).
Who is sponsoring clinical trial NCT04805333?
This trial is sponsored by Frederick R. Ueland, M.D., which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04805333 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ovarian Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04805333's enrollment target sits among peer trials
13 303rd of 322 higher than 18 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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