Phase I Study of Intravenous Artesunate for Solid Tumors
This trial is active, not recruiting.
|Collaborator||Department of Defense|
|Start date||January 2015|
|End date||December 2015|
|Trial size||18 participants|
|Trial identifier||NCT02353026, Pro028|
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.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Intravenous Artesunate administered on Day 1 and 8 every 3 weeks
Maximum Tolerated Dose
time frame: 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - 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 Exclusion Criteria: - 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
|Official title||A Phase I Study of Intravenous Artesunate in Patients With Solid Tumors|
|Principal investigator||John F Deeken, MD|
|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.|
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