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[A phase I study of DWA2114R]
Y Ariyoshi1, A Wakui, K Hasegawa
1Dept. of Medicine, Aichi Cancer Center, Nagoya, Japan.
Gan to Kagaku Ryoho. Cancer & Chemotherapy
|May 1, 1992
Summary
This Phase I clinical trial evaluated DWA2114R, a novel platinum analogue, in cancer patients. The study found DWA2114R to be well-tolerated at high doses, with leukocytopenia as the dose-limiting factor.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Context:
- A Phase I clinical trial was conducted across 13 institutions involving 39 patients with diverse tumor types.
- This study assessed the safety and tolerability of DWA2114R, a novel platinum analogue, in cancer patients.
Purpose:
- To determine the maximum tolerated dose (MTD) and dose-limiting factors (DLF) of DWA2114R.
- To evaluate the pharmacokinetic profile, including plasma platinum concentrations and urinary excretion.
- To establish a recommended dose for Phase II studies.
Summary:
- DWA2114R was administered intravenously, with doses escalating up to 1,000 mg/m2.
- Leukocytopenia, particularly neutropenia, was identified as the dose-limiting factor, with the MTD exceeding 1,000 mg/m2.
- Gastrointestinal toxicity was the primary clinical side effect; hepatotoxicity and nephrotoxicity were mild. Plasma platinum levels exhibited triphasic and biphasic decay patterns, with significant urinary excretion (54.2%–92.2%).
Impact:
- The recommended dose for Phase II studies was determined to be 800-1,000 mg/m2, administered every 3-4 weeks.
- Findings support further investigation of DWA2114R in specific cancer types.
- This research contributes to the development of new platinum-based chemotherapy agents.