Back to resultsPhase 1 Dose Escalation of ArtemiCoffee
Primary Purpose
Ovarian Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Artemisia annua 450mg
Artemisia annua 900mg
Artemisia annua 1350mg
Artemisia annua 1800mg
Artemisia annua - recommended phase II dose
Sponsored by
About this trial
This is an interventional treatment trial for Ovarian Cancer focused on measuring dose escalation, ArtemiCoffee, Artemisia annua, ART-Coffee, herbal
Eligibility Criteria
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.
Sites / Locations
- University of KentuckyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Dose 1 - 450mg Artemisia annua
Dose 2 - 900mg Artemisia annua
Dose 3 - 1350mg Artemisia annua
Dose 5 - 1800mg Artemisia annua
Dose Expansion - Recommended Phase II Dose
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Progression Free Survival
Median progression free survival will be calculated for all groups.
Full Information
NCT ID
NCT04805333
First Posted
March 16, 2021
Last Updated
January 4, 2023
Sponsor
Jill M Kolesar
Collaborators
ArtemiLife
1. Study Identification
Unique Protocol Identification Number
NCT04805333
Brief Title
Phase 1 Dose Escalation of ArtemiCoffee
Official Title
A Phase 1 Dose Escalation of ArtemiCoffee in Patients With Advanced Ovarian Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jill M Kolesar
Collaborators
ArtemiLife
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
dose escalation, ArtemiCoffee, Artemisia annua, ART-Coffee, herbal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dose 1 - 450mg Artemisia annua
Arm Type
Experimental
Arm Description
Participants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua).
Arm Title
Dose 2 - 900mg Artemisia annua
Arm Type
Experimental
Arm Description
Participants in this group will consume 2 cups of decaffeinated coffee (900 mg Artemisia annua).
Arm Title
Dose 3 - 1350mg Artemisia annua
Arm Type
Experimental
Arm Description
Participants in this group will consume 3 cups of decaffeinated coffee (1350 mg Artemisia annua).
Arm Title
Dose 5 - 1800mg Artemisia annua
Arm Type
Experimental
Arm Description
Participants in this group will consume 4 cups of decaffeinated coffee (1800 mg Artemisia annua).
Arm Title
Dose Expansion - Recommended Phase II Dose
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Artemisia annua 450mg
Intervention Description
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Intervention Type
Drug
Intervention Name(s)
Artemisia annua 900mg
Intervention Description
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Intervention Type
Drug
Intervention Name(s)
Artemisia annua 1350mg
Intervention Description
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Intervention Type
Drug
Intervention Name(s)
Artemisia annua 1800mg
Intervention Description
Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
Intervention Type
Drug
Intervention Name(s)
Artemisia annua - recommended phase II dose
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recommended Phase II Dose
Description
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.
Time Frame
150 days
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
Median progression free survival will be calculated for all groups.
Time Frame
150 days
Other Pre-specified Outcome Measures:
Title
Change in plasma concentration of artemisinin.
Description
The change in plasma concentration of artemisinin will be measured pre- and post-study.
Time Frame
Up to 150 days (baseline and post-treatment)
Title
Change in plasma concentration of dihydroartemisinin.
Description
The change in plasma concentration of dihydroartemisinin will be measured pre- and post-study.
Time Frame
Up to 150 days (baseline and post-treatment)
Title
Change in NQ01 expression.
Description
Change in cell-free (cfRNA) levels of NQ01 (NAD(P)H:quinone oxidoreductase 1) will be measured at baseline and post-treatment.
Time Frame
Up to 150 days (baseline and post-treatment)
Title
Change in HO-1 expression.
Description
Change in cell-free (cfRNA) levels of HO1 (heme oxygenase 1) will be measured at baseline and post-treatment.
Time Frame
Up to 150 days (baseline and post-treatment)
Title
Change in ABCF2 expression.
Description
Change in cell-free (cfRNA) levels of HO1 (ATP-binding cassette sub-family F member 2) will be measured at baseline and post-treatment.
Time Frame
Up to 150 days (baseline and post-treatment)
Title
Change in CD99 expression.
Description
Change in cell-free (cfRNA) levels of CD99 (ATP-binding cassette sub-family F member 2) will be measured at baseline and post-treatment.
Time Frame
Up to 150 days (baseline and post-treatment)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill Kolesar, PharmD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jill Kolesar, PharmD, MS
Phone
859-323-4978
Email
jill.kolesar@uky.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 1 Dose Escalation of ArtemiCoffee
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