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Phase 1 Dose Escalation of ArtemiCoffee

NCT04805333 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-02-10

No results posted yet for this study

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

Interventions

DRUG

Artemisia annua 450mg

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

DRUG

Artemisia annua 900mg

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

DRUG

Artemisia annua 1350mg

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

DRUG

Artemisia annua 1800mg

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

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.

Sponsors & Collaborators

  • ArtemiLife

    collaborator UNKNOWN

  • Frederick R. Ueland, M.D.

    lead OTHER

Principal Investigators

  • Frederick Ueland, MD · University of Kentucky

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-26
Primary Completion
2025-02-04
Completion
2025-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04805333 on ClinicalTrials.gov