Phase 1 Dose Escalation of ArtemiCoffee

NCT04805333 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MCC-20-GYN-08
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

dose escalation; ArtemiCoffee; Artemisia annua; ART-Coffee; herbal

Outcome Measures

Primary Outcomes (1)

• 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.

  150 days

Secondary Outcomes (1)

• Progression Free Survival

  150 days

Other Outcomes (6)

• Change in plasma concentration of artemisinin.

  Up to 150 days (baseline and post-treatment)

• Change in plasma concentration of dihydroartemisinin.

  Up to 150 days (baseline and post-treatment)

• Change in NQ01 expression.

  Up to 150 days (baseline and post-treatment)

Study Arms (5)

Dose 1 - 450mg Artemisia annua

EXPERIMENTAL

Participants in this group will consume 1 cup of decaffeinated coffee (450 mg Artemisia annua).

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).

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).

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).

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).

Drug: Artemisia annua - recommended phase II dose

Interventions

Artemisia annua 450mg DRUG

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Dose 1 - 450mg Artemisia annua

Artemisia annua 900mg DRUG

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Dose 2 - 900mg Artemisia annua

Artemisia annua 1350mg DRUG

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Dose 3 - 1350mg Artemisia annua

Artemisia annua 1800mg DRUG

Artemisia annua will be self-administered via a preparation of decaffeinated coffee.

Dose 5 - 1800mg Artemisia annua

Artemisia annua - recommended phase II dose DRUG

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.

Dose Expansion - Recommended Phase II Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Frederick R. Ueland, M.D.: lead
• ArtemiLife: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Frederick Ueland, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: March 26, 2021
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)