Phase I Study of Intravenous Artesunate for Solid Tumors

Georgetown University

Status and phase

Completed

Phase 1

Conditions

Solid Tumors

Treatments

Drug: Intravenous Artesunate

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT02353026

Pro028

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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