Syndax Pharmaceuticals, Inc. (Syndax) is committed to developing innovative new drugs for cancer patients. Syndax is focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products, and to obtain regulatory approval prior to marketing and distribution. Adequately designed and well-conducted clinical trials are essential in bringing new therapies to patients. The sponsor of a clinical trial has an ethical responsibility to protect the rights and safety of clinical trial participants, as well as to ensure the integrity of the trials being conducted.
The most efficient and ethical manner for a patient to access a medicine prior to it being approved by regulatory authorities is to enroll in a clinical trial. Patients who choose to participate in clinical trials play a critical role in developing new medicines.
Syndax recognizes that in certain circumstances, enrollment in a clinical trial may not be possible for patients facing serious or life-threatening conditions such as cancer, and patients may seek access to investigational medicines outside of a clinical trial. One approach to accessing investigational medicines outside of a clinical trial is through compassionate use, or expanded access programs, that allow early access.
Syndax may consider providing access to an investigational or unlicensed Syndax product if the following criteria are fulfilled:
- The patient suffers from a serious or immediately life-threatening disease or condition;
- The patient has undergone all appropriate standard of care treatments without success and no comparable or satisfactory alternative treatment/prophylaxis is available or exists to treat the disease or condition;
- The patient is ineligible for participation in any ongoing clinical study of the Syndax investigational product, which includes lack of access due to geographic limitations;
- The potential patient benefit justifies the potential risks of the treatment use, and those potential risks are not unreasonable in the context of the disease or condition to be treated; and
- The provision of the investigational product will not interfere with or compromise the clinical development of the product.
Syndax is committed to a fair and impartial evaluation of each request for access to our investigational medicines. If you are a treating health care provider who is seeking access for your patient, please provide your contact information here. We will attempt to acknowledge your request within two business days and provide you with further information to submit a formal request. Syndax cannot guarantee that a Syndax investigational product will be available for expanded access or compassionate use, or that the investigational medicine will be available to a particular patient.