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Whatever happened to NSC--? An analysis of clinical results of discontinued anticancer agents
Abstract:
Twenty-six investigational anticancer drugs formerly supplied by the National Cancer Institute are no longer available due to the lack of requests for their use in clinical trials. This report examines the data on these drugs to determine how well they were clinically evaluated. Generally, the studies are incomplete, and 34% of the compounds have not been studied beyond phase I trials. Clinical pharmacology data were not obtained for most of the drugs. In addition, the information available for drugs that did undergo phase II trials is grossly inadequate and does not permit a confident decision to withdraw them from investigational use. Instances of "hints" of activity and interesting drug properties are cited to stimulate further study. Finally, a list of compounds scheduled for future termination is given within the framework of this analysis to provoke thought toward obtaining more phase II data before these drugs fall into disuse.
Insights
Many investigational anticancer drugs are unavailable due to limited clinical trial requests. Evaluations are often incomplete, hindering decisions on their withdrawal from use.
Area of Science:
- Oncology
- Clinical Pharmacology
- Drug Development
Background:
- Twenty-six investigational anticancer drugs from the National Cancer Institute (NCI) are no longer available.
- Discontinuation is attributed to a lack of requests for their use in clinical trials.
Purpose of the Study:
- To assess the extent of clinical evaluation for these discontinued investigational anticancer drugs.
- To determine if available data adequately supports their withdrawal from investigational use.
Main Methods:
- Review of available clinical trial data for 26 previously supplied NCI investigational anticancer drugs.
- Analysis of study completeness, including progression through clinical trial phases (Phase I, Phase II).
- Evaluation of clinical pharmacology data availability.
Main Results:
- Most studies for these drugs are incomplete.
- 34% of the compounds were not studied beyond Phase I trials.
- Clinical pharmacology data is largely unavailable.
- Phase II trial data is inadequate to confidently support withdrawal decisions.
Conclusions:
- The clinical evaluation of these anticancer drugs is generally insufficient.
- Inadequate data prevents confident decisions regarding their discontinuation.
- Further investigation, particularly Phase II trials, is recommended for compounds with "hints" of activity or interesting properties before they are permanently removed from development.