Phase I Study of Intravenous Artesunate for Solid Tumors
- Registration Number
- NCT02353026
- Lead Sponsor
- Georgetown University
- Brief Summary
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.
- Detailed Description
A rapid dose escalation design will be used, in which single patients will be enrolled to each dose level until a grade \>/= 2 treatment-related toxicity occurs during cycle 1; enrollment then will proceed using a classic 3+ 3 dose escalation design. If the toxicity was grade 2, then enrollment will continue on that dose level. If the toxicity was grade 3 or 4, then enrollment will continue on one dose level below that dose. Dose escalation with the 3+3 design will continue until \>/= 2 patients out of 6 experience a treatment-related dose-limiting toxicity. Then, the maximum tolerated dose and recommended Phase II dose of intravenous artesunate will be one dose level below the level at which the toxicities occurred.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intravenous Artesunate Intravenous Artesunate Intravenous Artesunate administered on Day 1 and 8 every 3 weeks
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose 1 year One dose level below the dose at which 2 or more out of 6 patients experienced dose-limiting toxicities
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Georgetown Lombardi Comprehensive Cancer Center
🇺🇸Washington, District of Columbia, United States