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Phase 1 Dose Escalation of ArtemiCoffee | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Phase 1 Dose Escalation of ArtemiCoffee

A Phase 1 Dose Escalation of ArtemiCoffee in Patients With Advanced Ovarian Cancer

NCT04805333•Frederick R. Ueland, M.D.

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.

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. The primary objective of this study is to determine the recommended phase II dose (RP2D) of Aa decaf coffee pods. Sequential cohorts of three patients per cohort will have escalating doses of Aa, starting with one cup per day (450mg) and with a maximum of 4 cups per day (1800mg). After identifying the RP2D, the study will evaluate an expansion cohort of 6 patients for further tolerability and secondary endpoints. The secondary endpoints include: 1) Efficacy as measured by time to tumor progression or recurrence; 2) the ability of Aa decaf coffee to influence downstream biomarkers of the NRF2/KEAP1 signaling pathway; and 3) plasma concentrations of artemisinin and dihydroartemisinin.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Yes

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.

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Key Dates

Start Date

March 26, 2021

Primary Completion Date

February 4, 2025

Completion Date

February 4, 2025

Last Updated

February 10, 2025

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Artemisia annua 450mg

DRUG

Artemisia annua 900mg

DRUG

Artemisia annua 1350mg

DRUG

Artemisia annua 1800mg

DRUG

Artemisia annua - recommended phase II dose

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase 1 Dose Escalation of ArtemiCoffee

Inclusion Criteria

Exclusion Criteria

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