Clinical trial · Interventional
Phase 1 Dose Escalation of ArtemiCoffee
A Phase 1 Dose Escalation of ArtemiCoffee in Patients With Advanced Ovarian Cancer
NCT04805333CI-TRIAL-00085716completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Artemisia annua 1350mg | Drug | — | UNRESOLVED |
| Artemisia annua 1800mg | Drug | — | UNRESOLVED |
| Artemisia annua 450mg | Drug | — | UNRESOLVED |
| Artemisia annua 900mg | Drug | — | UNRESOLVED |
| Artemisia annua - recommended phase II dose | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose 1 - 450mg Artemisia annua
- description
- Participants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua).
- interventionNames
- Drug: Artemisia annua 450mg
- type
- EXPERIMENTAL
- label
- Dose 2 - 900mg Artemisia annua
- description
- Participants in this group will consume 2 cups of decaffeinated coffee (900 mg Artemisia annua).
- interventionNames
- Drug: Artemisia annua 900mg
- type
- EXPERIMENTAL
- label
- Dose 3 - 1350mg Artemisia annua
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.