Compassionate Use (Expanded Access)
Access to Investigational Medicines
At Corcept Therapeutics, we recognize that some patients with serious or life-threatening diseases may not be eligible for any clinical trial and may not have other treatment options. Corcept may be able to offer one of our investigational medicines to individual patients who have exhausted other treatment options and who might benefit from our medicine, provided criteria described below are met. This access includes investigational medicines that are not approved for any purpose in the country of intended use and additionally covers the time period between regulatory approval of an investigational product and its commercial availability.
Patients interested in access to a Corcept investigational medicine should speak with their treating physicians about their eligibility to enroll in any of Corcept's clinical trials. Information about available Corcept clinical trials can be accessed at ClinicalTrials.gov.
If the treating physician determines the patient does not qualify for an ongoing clinical trial, Corcept may provide investigational medicine through Compassionate Use, which is also known as Expanded Access. The treating physician should contact Corcept to make the request on behalf of the patient.
Procedure for Making a Request for an Investigational Medicine
A treating physician who is able to comply with the requirements that are stated in this document may request information about how to apply for access to Corcept’s investigational products by contacting Corcept at 650-327-3270 or email: firstname.lastname@example.org.
Corcept will acknowledge receipt of such request within one (1) business day.
General Criteria for Access to Corcept Investigational Medicines
The risk-benefit of treatment with the investigational medicine must be considered. Decisions regarding potential access to investigational medicines can only be made with consideration of criteria including those listed below, and after discussions between the Corcept clinical team and the patient's qualified treating physician acting on his or her behalf.
- The medicine is under investigation in one or more Corcept clinical studies.
- Sufficient evidence must exist to expect that the investigational medicine will have an acceptable safety profile for the intended patient.
- There must be an adequate supply of the investigational medicine such that Expanded Access will not interfere with ongoing or planned clinical studies or with the supply of drug to patients already receiving the medicine through Expanded Access.
- Use of the investigational medicine must comply with FDA or applicable ex-US regulations and be approved by the treating physician’s Institutional Review Board/Ethics Committee.
- Patients must suffer from a serious or life-threatening disease or condition;
- Patients must have undergone appropriate standard treatments without success and no comparable or satisfactory alternative treatment is available.
- Patients are ineligible for participation in any ongoing clinical study of the investigational product, which includes lack of access due to geographic limitations;
- Patients must meet any other pertinent medical criteria, such as a disease similar to indication(s) under investigation by Corcept on the investigational medicine.
Treating Physician and Their Responsibilities
- The treating physician is properly licensed and qualified to administer the investigational medicine.
- The physician must agree in writing to comply with:
a) Any applicable country-specific legal and regulatory requirements related to providing an investigational or unlicensed medicine under Compassionate Use; and b) Any Corcept requirements in terms of medical criteria, safety reporting, drug supply/use, and protection of intellectual property.
How Decisions for Expanded Access are Made at Corcept
Corcept is committed to a fair and impartial evaluation of each request for access to our investigational medicine. All decisions are based solely on clinical circumstances. Whenever possible, patients will be referred to ongoing clinical trials as the primary way to access investigational medicines.
Patients and treating physicians are advised that there is no guarantee of access to any specific investigational medicine through Expanded Access (Compassionate Use).