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NCT Number: NCT02353026

Phase I Study of Intravenous Artesunate for Solid Tumors

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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intravenous Artesunate

Drug

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

  1. Maximum Tolerated Dose

    Time frame: 1 year

    One dose level below the dose at which 2 or more out of 6 patients experienced dose-limiting toxicities

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

A Phase I Study of Intravenous Artesunate in Patients With Solid Tumors

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 2, 2015
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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