Cancer Clinical Trial
Official title:
A Phase 1, Open-label, Dose-escalation Study of SNX 5422 and Everolimus in Subjects With Neuroendocrine Tumors.
Study is designed to determine the maximum tolerated dose (MTD) of SNX-5422 when given in combination with everolimus.
Heat shock protein 90 (Hsp90) plays a central role in the maturation and maintenance of
numerous proteins, for example HER2 and mutated EGFR, that are critical for tumor cell
viability and growth; SNX-5422 is a pro-drug of SNX-2112, a potent, highly selective,
small-molecule inhibitor of the molecular chaperone heat shock protein 90 (Hsp90). Hsp90 has
been found to be expressed in 95% of subjects with pancreatic neuroendocrine tumors.
This study will determine the MTD of SNX-5422 when given in combination with everolimus in
patients with neuroendocrine tumors.The clinical starting dose of 50 mg/m2 qod for SNX-5422
in combination with daily everolimus is 50% of the SNX-5422 qod mono-therapy MTD. The choice
to continue once every other day SNX-5422 dosing is based on the safety and efficacy profiles
from prior studies, so that drug holidays are interspersed into weekly dosing. The planned
subsequent dose levels are 75% and 100% of the SNX-5422 qod mono-therapy MTD.
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