New medicines undergoing clinical development are often referred to as “investigational medicines” before approval by a regulatory body such as the Food and Drug Administration (FDA) for the United States, the European Medicines Agency (EMA) for the European Union, etc. Clinical trials are the most common route for patient access to investigational medicines. Participation in clinical trials is vital to the evaluation of safety and effectiveness of new medicines. Oncternal encourages patients to discuss with their licensed healthcare professional whether participating in a clinical trial could be a potential option for them. Information about Oncternal’s open clinical trial for ONCT-534 is available on www.clinicaltrials.gov.
In some cases, regulatory authorities allow access to investigational medicines outside of a clinical trial if certain conditions are met. The use of investigational medicines outside of a clinical trial is known under various terms such as Pre-Approval Access, Expanded Access, or Named Patient Programs (also widely referred to as compassionate use). The conditions include but are not limited to:
- Patient must have a serious, life-threatening or severely debilitating disease
- Patient must be unable to participate in a clinical trial due to eligibility criteria or other reasons
- No satisfactory or comparable alternative treatment options are available
- Potential benefits of treatment with the investigational medicine outweigh the potential risks and an appropriate dose has been established, both in the determination of Oncternal
- Adequate supply is available to support e.g., clinical development activities and expanded access
- Such access must be allowed under local country laws and regulations
At this time Oncternal is not able to offer expanded access to ONCT-534.
More information on existing Expanded Access Programs in the U.S. may be found by searching for Expanded Access records on www.clinicaltrials.gov.