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A phase I study of intravenous artesunate in patients with advanced solid tumor malignancies

John F Deeken1, Hongkun Wang2, Marion Hartley2

  • 1Inova Schar Cancer Institute, Inova Health System, 3300 Gallows Road, Falls Church, VA, 22042, USA. john.deeken@inova.org.

Cancer Chemotherapy and Pharmacology
|February 3, 2018
PubMed
Abstract

Insights

Intravenous artesunate (IV AS) showed a maximum tolerated dose of 18 mg/kg in a Phase I study. While no complete responses were observed, the drug demonstrated modest clinical activity and was well tolerated in pre-treated patients.

Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Artemisinin derivatives exhibit anti-cancer properties in preclinical models.
  • Potential mechanisms include DNA damage, anti-angiogenesis, and apoptosis induction.

Purpose of the Study:

  • To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of intravenous artesunate (IV AS).

Main Methods:

  • Phase I, accelerated titration dose escalation study.
  • Dose levels ranged from 8 to 45 mg/kg given on days 1 and 8 of a 21-day cycle.
  • Toxicity assessed by NCI CTCAE (ver. 4.0), response by RECIST (v1.1), and pharmacokinetics (PK) during cycle 1.

Main Results:

  • 19 patients enrolled; 18 evaluable for toxicity, 15 for efficacy.
  • MTD established at 18 mg/kg, with DLTs including neutropenic fever and liver function abnormalities.
  • 27% disease control rate observed, with three patients achieving prolonged stable disease.

Conclusions:

  • The MTD for IV AS is 18 mg/kg on the studied schedule.
  • IV AS was well tolerated and showed modest clinical activity in a heavily pre-treated population.
  • Further investigation in Phase II trials may be warranted.
Keywords:
ArtesunateClinical trialPhase ISolid tumors

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