Overview

This trial has been completed.

Condition solid tumors
Treatment intravenous artesunate
Phase phase 1
Sponsor Georgetown University
Collaborator United States Department of Defense
Start date January 2015
End date December 2015
Trial size 19 participants
Trial identifier NCT02353026, Pro028

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intravenous Artesunate administered on Day 1 and 8 every 3 weeks
intravenous artesunate
Intravenous Artesunate in escalating doses: 8, 12, 18, 25, 34, 45 mg/kg on days 1 and 8 of every 3 week cycles

Primary Outcomes

Measure
Maximum Tolerated Dose
time frame: 1 year

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Georgetown University.