Phase 1 Dose Escalation of ArtemiCoffee

February 6, 2025 updated by: Frederick R. Ueland, M.D.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose 1 - 450mg Artemisia annua
Participants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua).
Drug: Artemisia annua 450mg
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Experimental: Dose 2 - 900mg Artemisia annua
Participants in this group will consume 2 cups of decaffeinated coffee (900 mg Artemisia annua).
Drug: Artemisia annua 900mg
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Experimental: Dose 3 - 1350mg Artemisia annua
Participants in this group will consume 3 cups of decaffeinated coffee (1350 mg Artemisia annua).
Drug: Artemisia annua 1350mg
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Experimental: Dose 5 - 1800mg Artemisia annua
Participants in this group will consume 4 cups of decaffeinated coffee (1800 mg Artemisia annua).
Drug: Artemisia annua 1800mg
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Experimental: Dose Expansion - Recommended Phase II Dose
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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended Phase II Dose
Time Frame: 150 days
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.
150 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 150 days
Median progression free survival will be calculated for all groups.
150 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in plasma concentration of artemisinin.
Time Frame: Up to 150 days (baseline and post-treatment)
The change in plasma concentration of artemisinin will be measured pre- and post-study.
Up to 150 days (baseline and post-treatment)
Change in plasma concentration of dihydroartemisinin.
Time Frame: Up to 150 days (baseline and post-treatment)
The change in plasma concentration of dihydroartemisinin will be measured pre- and post-study.
Up to 150 days (baseline and post-treatment)
Change in NQ01 expression.
Time Frame: Up to 150 days (baseline and post-treatment)
Change in cell-free (cfRNA) levels of NQ01 (NAD(P)H:quinone oxidoreductase 1) will be measured at baseline and post-treatment.
Up to 150 days (baseline and post-treatment)
Change in HO-1 expression.
Time Frame: Up to 150 days (baseline and post-treatment)
Change in cell-free (cfRNA) levels of HO1 (heme oxygenase 1) will be measured at baseline and post-treatment.
Up to 150 days (baseline and post-treatment)
Change in ABCF2 expression.
Time Frame: Up to 150 days (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.
Up to 150 days (baseline and post-treatment)
Change in CD99 expression.
Time Frame: Up to 150 days (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.
Up to 150 days (baseline and post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frederick R. Ueland, M.D.

Collaborators

ArtemiLife

Investigators

  • Principal Investigator: Frederick Ueland, MD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

February 4, 2025

Study Completion (Actual)

February 4, 2025

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-20-GYN-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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