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Clinical Trial
. 1992;118(8):606-8.
doi: 10.1007/BF01211805.

A dose-finding study of miltefosine (hexadecylphosphocholine) in patients with metastatic solid tumours

J Verweij  1 , A Planting, M van der Burg, G Stoter
Affiliations
Clinical Trial

A dose-finding study of miltefosine (hexadecylphosphocholine) in patients with metastatic solid tumours

J Verweij et al. J Cancer Res Clin Oncol. 1992.

Abstract

The ether lipid miltefosine (hexadecylphosphocholine) was orally given to patients with various tumours in a dose-finding study. All patients initially received a daily total dose of 100 mg, which in the absence of side-effects was increased to 150 mg and further to 200 mg. A total of 54 patients were entered and were evaluable for gastrointestinal toxicity. Nausea and vomiting were found to be dose-limiting; 22% of patients ultimately tolerated a dose of 100 mg, 59% tolerated a dose of 150 mg and 19% tolerated a dose of 200 mg. In addition 30% of patients developed renal dysfunction, which was thought to be related to the drug. No other toxicities were observed. For further phase II studies it is recommended that one starts with a dose of 150 mg daily, divided over three administrations.

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References

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