NCT04805333

Phase 1 Dose Escalation of ArtemiCoffee

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Frederick R. Ueland, M.D. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Artemisia annua 450mg	Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
DRUG	Artemisia annua 900mg	Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
DRUG	Artemisia annua 1350mg	Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
DRUG	Artemisia annua 1800mg	Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
DRUG	Artemisia annua - recommended phase II dose	Artemisia annua will be self-administered via a preparation of decaffeinated coffee. The dose for this cohort will be based on analysis of previous cohorts.

Timeline

• Start date: 2021-03-26
• Primary completion: 2025-02-04
• Completion: 2025-02-04
• First posted: 2021-03-18
• Last updated: 2025-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study