Phase I dose escalation of ArtemiCoffee in women with advanced ovarian cancer

Connie Cao; Donglin Yan; Lauren Baldwin; Rachel Miller; Charles Dietrich; Frederick Ueland; Jill Kolesar

doi:10.1016/j.ygyno.2025.04.359

Objectives Artemesia annua (Aa) is a medicinal plant that has been used for centuries as an antimalarial agent. Recent evidence suggests preclinical anticancer activity in ovarian cancer. Aa decaf coffee pods containing 450 mg Aa are commercially available as ArtemiCoffee. Methods This phase I dose escalation study used a Bayesian optimal interval (BOIN) design to determine the recommended phase II dose of ArtemiCoffee. Secondary endpoints were to determine adverse effects, progression-free survival (PFS) and pharmacokinetics. Eligibility criteria included patients with stage II-IV ovarian, peritoneal or fallopian tube cancer and those who had completed chemotherapy and achieved a partial or complete response. Concurrent poly (ADP-ribose) polymerase (PARP) inhibitor (PARPi) therapy was allowed. One month after completing chemotherapy, patients daily self-administered ArtemiCoffee. Doses were escalated by cohort, starting at one cup per day and increasing up to four cups per day in 28-day cycles for a total of five cycles. We defined dose-limiting toxicities (DLT) as grade 2 or greater, with the exception of nausea, where grade 3 was considered a DLT. Results A total of twelve out of thirteen patients were eligible and evaluable for toxicity and activity. One patient withdrew prior to initiating therapy. All were female, with a median age of 69. Twelve patients received one prior treatment and one patient had two prior therapies. Six patients had a BRCA1/BRCA2 mutation and received concurrent PARPi. Three patients were treated at dose levels 1–4, and no patient experienced dose-limiting toxicity (DLT) with a posterior DLT estimate of 0.17 (95 % Credible Interval of 0.01, 0.53) for dose level 4. The most common grade 1 adverse effect was diarrhea (2/12, 17 %). Of the evaluable patients, seven completed all five cycles of therapy, one developed COVID-19 and went off study, and four progressed on treatment. All (6/6) patients with concurrent PARPi completed therapy, while 50 % (3/6) without PARPi completed primary therapy without progression. The median PFS and overall survival have not yet been reached. Conclusions ArtemiCoffee administered up to four times a day for five months is safe. The recommended phase II dose is four cups per day (1800 mg).

Phase I dose escalation of ArtemiCoffee in women with advanced ovarian cancer

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