Clinical trials are studies that are critical for the investigation of new and innovative medicines. Through participation in clinical trials, patients can access investigational drug candidates, helping to play a crucial role in the process that determines a drug’s eligibility for approval by the U.S. Food and Drug Administration (FDA). At Turning Point, we are currently enrolling patients in clinical studies in patients with genetically driven solid tumor cancers.
Repotrectinib, elzovantinib, TPX-0046, TPX-0131 and TPX-4589 are investigational drug candidates and have not been approved for marketing by the FDA or other regulatory authorities.
Questions about our clinical trials?
Contact us via email at clinical@tptherapeutics.com or by phone at 858.276.0005.
Compassionate Use
Access to Investigational Medicines
Turning Point Therapeutics is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. You can learn more about our ongoing clinical trials on our website or on ClinicalTrials.gov.
In some cases, we may be able to provide patients access to our investigational drugs outside of a clinical trial if certain conditions are met and if permitted by local law and regulation. The use of investigational drugs outside of a clinical trial is known as “Expanded Access” but may go by other names.
Expanded Access, also known as Compassionate Use, is the use of an investigational medical product prior to FDA approval and outside of use in a clinical trial. Requests for investigational drugs through the Single Patient Expanded Access program must be submitted by a treating physician.
At this time, the Expanded Access program is for the investigational drug repotrectinib only, for treatment of patients with ROS1+ or NTRK+ solid tumors. If you have a question about a different investigational drug, please submit an inquiry to Turning Point Medical Information at medinfo@tptherapeutics.com.
Eligibility Requirements
Single Patient Expanded Access may not always be available and requires the individual patient meet certain eligibility conditions. To be eligible for access to an investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria:
- Diagnosed with a serious, life-threatening or severely debilitating disease;
- Unable to participate in Turning Point Therapeutics clinical trials;
- Have no comparable or satisfactory alternative treatment option available;
- The risk/benefit profile of the investigational drug is favorable in light of the sufficient safety and efficacy information and the treating physician’s assessment of the patient’s medical condition; and
- Turning Point has the regulatory and drug distribution infrastructure in the country or region to support expanded access. If you have a question about availability of expanded access in your region, please submit an inquiry to Turning Point Medical Information at medinfo@tptherapeutics.com.
How to Apply
Physician requests can be submitted through our Compassionate Use portal.
Patients interested in obtaining access to a Turning Point investigational medicine must do so via their physician.
Review Process
Medical professionals at Turning Point Therapeutics will individually review each request, consistent with our policy on pre-approval access and the program eligibility requirements. Turning Point is committed to a fair and impartial evaluation of each request, however, meeting the above criteria does not guarantee access to an investigational drug.
This policy is subject to change.
