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Participants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua).

Participants in this group will consume 2 cups of decaffeinated coffee (900 mg Artemisia annua).

Participants in this group will consume 3 cups of decaffeinated coffee (1350 mg Artemisia annua).

Participants in this group will consume 4 cups of decaffeinated coffee (1800 mg Artemisia annua).

This cohort will be an expansion of 6 patients for further tolerability and secondary endpoints analysis. They will consume the recommended phase II dose (dependent on prior analysis).

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Artemisia annua 450mg

Artemisia annua 900mg

Artemisia annua 1350mg

Artemisia annua 1800mg

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.

Artemisia annua - recommended phase II dose

Jill Kolesar, PharmD, MS

Jill Kolesar, PharmD

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.

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.

Phase 1 Dose Escalation of ArtemiCoffee

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

The change in plasma concentration of artemisinin will be measured pre- and post-study.

The change in plasma concentration of dihydroartemisinin will be measured pre- and post-study.

Change in cell-free (cfRNA) levels of NQ01 (NAD(P)H:quinone oxidoreductase 1) will be measured at baseline and post-treatment.

Change in cell-free (cfRNA) levels of HO1 (heme oxygenase 1) will be measured at baseline and post-treatment.

Change in cell-free (cfRNA) levels of HO1 (ATP-binding cassette sub-family F member 2) will be measured at baseline and post-treatment.

Change in cell-free (cfRNA) levels of CD99 (ATP-binding cassette sub-family F member 2) will be measured at baseline and post-treatment.

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.

Median progression free survival will be calculated for all groups.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Phase 1 Dose Escalation of ArtemiCoffee	NCT04805333	Ovarian Cancer	Artemisia annua... Artemisia annua... Artemisia annua... Artemisia annua... Artemisia annua...	18 Years -	University of Kentucky
Phase 1 Dose Escalation of ArtemiCoffee	NCT04805333	Ovarian Cancer	Artemisia annua... Artemisia annua... Artemisia annua... Artemisia annua... Artemisia annua...	18 Years -	University of Kentucky

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