Related Experiment Videos
[Phase I study of bestrabucil (KM 2210)]
Gan to Kagaku Ryoho. Cancer & Chemotherapy
|June 1, 1986
Summary
This phase I study evaluated Bestrabucil (KM 2210), an antitumor agent. The maximum tolerated dose was determined to be 700-800 mg/body, with dose-limiting toxicities including gastrointestinal issues and pain.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Context:
- Bestrabucil (KM 2210) is a novel antitumor agent.
- Phase I clinical trials are essential for evaluating new cancer therapies.
Purpose:
- To assess the safety, tolerability, and maximum tolerated dose (MTD) of Bestrabucil (KM 2210).
- To identify dose-limiting toxicities (DLTs) associated with Bestrabucil administration.
Summary:
- The study involved single and five-consecutive-day administration of Bestrabucil, escalating doses up to 800 mg/body.
- Dose-limiting factors included tarry stools, decreased hemoglobin, and breast pain. The MTD was established at 700-800 mg/body.
- Long-term administration revealed decreased peripheral leukocyte count as a DLT, with gastrointestinal side effects and hormone-related symptoms also observed.
Impact:
- Establishes the MTD and safety profile of Bestrabucil for future clinical development.
- Provides crucial data for dose selection in subsequent antitumor agent trials.
- Highlights potential side effects requiring monitoring in patients receiving Bestrabucil.