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Trial record 7 of 8 for:    artemisinin | cancer

Phase 1 Dose Escalation of ArtemiCoffee

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ClinicalTrials.gov Identifier: NCT04805333
Recruitment Status : Not yet recruiting
First Posted : March 18, 2021
Last Update Posted : March 18, 2021
Sponsor:
Collaborator:
ArtemiLife
Information provided by (Responsible Party):
Jill M Kolesar, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Artemisia annua 450mg Drug: Artemisia annua 900mg Drug: Artemisia annua 1350mg Drug: Artemisia annua 1800mg Drug: Artemisia annua - recommended phase II dose Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Dose Escalation of ArtemiCoffee in Patients With Advanced Ovarian Cancer
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 150 days ]
    Median progression free survival will be calculated for all groups.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04805333


Locations
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United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Jill M Kolesar
ArtemiLife
Investigators
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Principal Investigator: Jill Kolesar, PharmD University of Kentucky
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Responsible Party: Jill M Kolesar, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT04805333    
Other Study ID Numbers: MCC-20-GYN-08
First Posted: March 18, 2021    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill M Kolesar, University of Kentucky:
dose escalation
ArtemiCoffee
Artemisia annua
ART-Coffee
herbal
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Ovarian Epithelial
Ovarian Diseases
Adnexal Diseases
Endocrine System Diseases
Gonadal Disorders
Carcinoma