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- The patient and a licensed physician are both willing to participate.
- The patient’s physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition.
- The probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition.
- FDA determines that there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance;
- The sponsor (generally the company developing the investigational product for commercial use) or the clinical investigator (or the patient’s physician in the case of a single patient expanded access request) submits a clinical protocol (a document that describes the treatment plan for the patient) that is consistent with FDA’s statute and applicable regulations for INDs or investigational device exemption applications (IDEs), describing the use of the investigational product; and
- The patient is unable to obtain the investigational drug under another IND or to participate in a clinical trial.
Expanded Access
Calithera is committed to providing solutions to meet the medical needs of people with cancer and other life threatening diseases.
Our expanded access policy evaluates providing our investigational medicines outside of a clinical trial, as permitted by applicable law, once all available medical options have been exhausted.
Clinical Trials
Our goal, whenever possible, is to encourage patients to participate in our clinical trials. Clinical trials are well-controlled voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of investigational drugs. Participants in clinical trials are closely monitored and receive quality care and additional attention from clinical trial staff in all aspects of their disease, and therefore clinical trials often provide the safest opportunity for people to access an investigational drug before it is approved by a regulatory agency. Clinical trials can offer an opportunity to contribute to help others through the advancement of science, and to possibly receive the newest treatment.
Expanded Access
Expanded access, also known as compassionate use, may be an option for a limited number of individuals with serious or life-threatening conditions, and who have exhausted all available medical options and who do not qualify for clinical trials. Calithera may provide access to its investigational drugs to patients who meet specific criteria through expanded access. Currently we do not have an expanded access program or compassionate use program for any of our investigational products. If we provide access through expanded access in the future, the following are some of the general threshold criteria that must be met for Calithera to consider granting expanded access:
Process for requesting expanded access (compassionate use)
A qualified physician who believes that his/her patient may benefit from access to a Calithera investigational drug outside of a clinical trial should contact Calithera’s clinical team at:
Tina Woo
Director, Clinical Operations