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Phase I evaluation of IMPY in a twice weekly schedule
Cancer Treatment Reports
|May 1, 1981
Summary
This study investigated IMPY in advanced cancer patients, finding dose-limiting toxicities like nausea and fatigue. A recommended starting dose of 1200 mg/m2 twice weekly is suggested for phase II trials.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Advanced cancer presents significant treatment challenges.
- Identifying safe and effective dosing for novel therapeutics is crucial.
Purpose of the Study:
- To evaluate the safety and tolerability of IMPY in patients with advanced cancer.
- To determine dose-limiting toxicities and establish a recommended dose for phase II studies.
Main Methods:
- A phase I dose-escalation study of IMPY was conducted in 25 advanced cancer patients.
- IMPY was administered twice weekly on an escalating dose schedule from 165 to 3000 mg/m2.
Main Results:
- Dose-limiting toxicities included nausea, vomiting, fatigue, generalized weakness, and decreased performance status.
- One patient at 3000 mg/m2 developed dose-limiting hemolytic anemia.
- No tumor regression was observed in any patient.
Conclusions:
- The maximum tolerated dose was not reached within the studied range due to dose-limiting toxicities.
- A starting dose of 1200 mg/m2 twice weekly, with escalation to 1800 mg/m2, is proposed for phase II studies.