Aman Chauhan, MD, Oncologist at the University of Miami, discusses details of a phase 3 study testing paltusotine in patients with carcinoid syndrome due to neuroendocrine tumors (NETs).
NETs are rare tumors that usually develop in the GI tract or lungs, but may develop in other parts of the body, such as the pancreas, testicle, or ovary. In later stages, symptoms may vary depending on where the tumor is located. The tumor may produce hormone-like substances that spread to the body and cause symptoms of carcinoid syndrome, such as flushing of the face and chest, diarrhea, and trouble breathing. The cause of neuroendocrine neoplasms is unknown.
Paltusotine is a selectively-targeted somatostatin receptor type 2(SST2) nonpeptide. The treatment is currently approved by the U.S. Food and Drug Administration (FDA) for patients with acromegaly.
The phase 3 CAREFNDR (NCT07087054) clinical trial is a randomized, international, multicenter, placebo-controlled, double-blind study evaluating paltusotine in carcinoid syndrome due to NET. Patients will be treated for 16 weeks with a primary endpoint of change from baseline in flushing frequency at week 12. A second phase 3 trial is also in development, testing the nonpeptide drug candidate, CRN09682, in patients with somatostatin receptor 2-expressing tumors. The CAREFNDR study is currently enrolling patients. For more information, visit carefndr.com.
This study builds on a phase 2 study previously presented. Results from this study in carcinoid syndrome demonstrated rapid and sustained reductions in flushing episodes and bowel movement frequency. A preliminary analysis of phase 2 data from the open-label trial of paltusotine in the treatment of patients with carcinoid syndrome due to NETs showed an overall investigator-assessed progression free survival rate of 74% following one year of treatment.
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To learn more about neuroendocrine tumors and other rare endocrine disorders, visit https://checkrare.com/diseases/endocrine-disorders/