Phase I Study of Intravenous Artesunate for Solid Tumors

Completed · Phase 1

Conditions studied: Solid Tumors

In brief

This is a Phase One study to determine the safety, tolerability, and maximum tolerated dose of intravenous artesunate in patients with solid tumors. A rapid dose escalation design will be used, in which single patients will be enrolled to escalating dose levels until a grade 2 or higher toxicity occurs during cycle 1. Enrollment will then continue using 3 to 6 patients at each dose level until a dose is reached at which 2 or more patients out of 6 experience a treatment-related toxicity.

Key facts

Study ID

NCT02353026

Run by

Georgetown University

People needed

19

Starts

2015-01-01

Expected to finish

2015-12-01

Last updated by the study team

2016-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least one measurable lesion by RECIST criteria
• Willing to undergo pharmacogenetic testing
• Over the age of 18 years and able to provide informed consent
• No standard of care therapy available which has a proven overall survival benefit
• Adequate kidney, liver, and bone marrow function
• Life expectancy of greater than 3 months
• ECOG performance status less than or equal to 2

You may not qualify if…

• Chemotherapy or surgery within 4 weeks of treatment start
• Radiation treatment within 3 weeks prior to treatment start
• Untreated brain metastases or neurologically unstable CNS metastases
• Any severe or uncontrolled medical condition or other condition which could affect participation in the study including: unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction </= 6 months prior to study entry
• Previous diagnosis of alpha- or beta-thalassemia
• Patients on a medication or herbal therapy known to inhibit CYP2A6, UGT1A9, or UGT2B7
• Female patients who are pregnant or breast feeding, or adult patients who are of reproductive potential and are unwilling to refrain from conceiving a child during study treatment
• Patients unwilling or unable to comply with the protocol, or provide informed consent

Where it is running

• Georgetown Lombardi Comprehensive Cancer Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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