Ovarian CancerPhase 1NCT04805333
Phase 1 Dose Escalation of ArtemiCoffee
A Phase 1 study testing Artemisia annua 450mg, Artemisia annua 900mg and Artemisia annua 1350mg in people with Ovarian Cancer, run by Frederick R. Ueland, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Artemisia annua 450mg, Artemisia annua 900mg and Artemisia annua 1350mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 4 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Artemisia annua 450mg, Artemisia annua 900mg, Artemisia annua 1350mg, Artemisia annua 1800mg, Artemisia annua - recommended phase II dose
- Keywords
- dose escalation, ArtemiCoffee, Artemisia annua, ART-Coffee, herbal
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemisia annua 450mgDrug
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Artemisia annua 900mgDrug
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Artemisia annua 1350mgDrug
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Artemisia annua 1800mgDrug
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Artemisia annua - recommended phase II doseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 - 450mg Artemisia annua | Experimental | Participants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua). Receives: Drug: Artemisia annua 450mg |
| Dose 2 - 900mg Artemisia annua | Experimental | Participants in this group will consume 2 cups of decaffeinated coffee (900 mg Artemisia annua). Receives: Drug: Artemisia annua 900mg |
| Dose 3 - 1350mg Artemisia annua | Experimental | Participants in this group will consume 3 cups of decaffeinated coffee (1350 mg Artemisia annua). Receives: Drug: Artemisia annua 1350mg |
| Dose 5 - 1800mg Artemisia annua | Experimental | Participants in this group will consume 4 cups of decaffeinated coffee (1800 mg Artemisia annua). Receives: Drug: Artemisia annua 1800mg |
| Dose Expansion - Recommended Phase II Dose | Experimental | 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). Receives: Drug: Artemisia annua - recommended phase II dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose
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.
Measured: 150 days
Secondary outcomes (1)
Progression Free Survival
Median progression free survival will be calculated for all groups.
Measured: 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start26 Mar 2021
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederick R. Ueland, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- ArtemiLife
- Responsible party
- Sponsor-investigator, Frederick R. Ueland, M.D., University of Kentucky
- Investigators
- Frederick Ueland, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805333
- Sponsor's protocol ID
- MCC-20-GYN-08
- Status last verified
- Feb 2025
- First submitted
- 16 Mar 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Dose Escalation of ArtemiCoffee in Patients With Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT04805333
- Acronym / sponsor ID
- MCC-20-GYN-08
- Conditions
- Ovarian Cancer
- Keywords
- dose escalation, ArtemiCoffee, Artemisia annua, ART-Coffee, herbal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Frederick R. Ueland, M.D.University, hospital or other
- Collaborators
- ArtemiLife
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dose 1 - 450mg Artemisia annua | Experimental | Drug: Artemisia annua 450mgParticipants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua). |
| Dose 2 - 900mg Artemisia annua | Experimental | Drug: Artemisia annua 900mgParticipants in this group will consume 2 cups of decaffeinated coffee (900 mg Artemisia annua). |
| Dose 3 - 1350mg Artemisia annua | Experimental | Drug: Artemisia annua 1350mgParticipants in this group will consume 3 cups of decaffeinated coffee (1350 mg Artemisia annua). |
| Dose 5 - 1800mg Artemisia annua | Experimental | Drug: Artemisia annua 1800mgParticipants in this group will consume 4 cups of decaffeinated coffee (1800 mg Artemisia annua). |
| Dose Expansion - Recommended Phase II Dose | Experimental | Drug: Artemisia annua - recommended phase II doseThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemisia annua 450mgArtemisia annua will be self-administered via a preparation of decaffeinated coffee. | Drug | Dose 1 - 450mg Artemisia annua |
| Artemisia annua 900mgArtemisia annua will be self-administered via a preparation of decaffeinated coffee. | Drug | Dose 2 - 900mg Artemisia annua |
| Artemisia annua 1350mgArtemisia annua will be self-administered via a preparation of decaffeinated coffee. | Drug | Dose 3 - 1350mg Artemisia annua |
| Artemisia annua 1800mgArtemisia annua will be self-administered via a preparation of decaffeinated coffee. | Drug | Dose 5 - 1800mg Artemisia annua |
| Artemisia annua - recommended phase II doseArtemisia annua will be self-administered via a preparation of decaffeinated coffee. The dose for this cohort will be based on analysis of previous cohorts. | Drug | Dose Expansion - Recommended Phase II Dose |
Primary outcome
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.
1 secondary outcome
Progression Free Survival
Time frame: 150 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Ueland, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Artemisia annua 450mg, Artemisia annua 900mg and Artemisia annua 1350mg in people with Ovarian Cancer, run by Frederick R. Ueland, M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase II Dose (time frame: 150 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.