The first step in making a new drug available to the general public is conducting a rigorous series of clinical trials involving volunteers to evaluate the safety and effectiveness of the investigational therapy.
Each trial is supervised, monitored and documented. Data from these clinical trials ultimately could support approval by regulatory agencies (such as the Food and Drug Administration in the United States), allowing a new therapy to become available for the benefit of many patients with cancer.
Clinical trial volunteers play a critical role in this process and we sincerely thank all of you patient heroes, as well as your supportive family and friends, for your participation in our clinical trials to make this journey possible.
SEACRAFT-1 (ERAS-254-01)
SEACRAFT-2 (ERAS-254-02)
In any nautical journey, seacraft are needed to traverse the vast blue ocean not just in their capacity as seagoing ships, but also for their important second meaning: skill in navigation. Erasca is navigating the “blue ocean” of unmet medical needs using next generation sequencing and other techniques to identify RAS/MAPK pathway-altered tumors that can be treated with naporafenib, a potent, selective, orally bioavailable pan-RAF inhibitor, in combination with other targeted therapies. The SEACRAFT series of trials, beginning with SEACRAFT-1 and SEACRAFT-2, will test whether naporafenib can improve outcomes in patients with pan-RAS Q61X solid tumors, and NRASm melanoma, respectively.
For any questions about our clinical trials, please contact us via email at clinicaltrials@erasca.com
Erasca is a clinical-stage precision oncology company driven by our mission to erase cancer. Evaluation of our investigational therapies in clinical trials is necessary to collect all the information required for regulatory review and to eventually make life-saving therapies commercially available to the relevant patient populations. As such, our development resources are focused on obtaining the efficacy and safety information required for regulatory approval for our investigational therapies as expeditiously and safely as possible. Participation in a clinical trial is the best way for a patient to gain access to investigational therapies. Additional Information about all our ongoing clinical trials can be found at clinicaltrials.gov.
When enrollment into a clinical trial is not possible and all other available treatment options have been exhausted, access to an investigational therapy in the United States may be provided prior to regulatory approval or commercial approval under a provision referred to as “Expanded Access” (sometimes also referred to as “compassionate use”).
Expanded Access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational therapy for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. FDA guidelines indicate that Expanded Access may be appropriate when all of the following apply:
In accordance with the 21st Century Cures Act, Erasca may revise this Expanded Access Policy at any time.
If you have any questions about our Expanded Access Policy, please contact Erasca through the following email address: clinicaltrials@erasca.com.