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June 5, 2014
07:12 EDTCRISCuris announces re-initiation of patient dosing in CUDC-427 monotherapy trial
Curis announced that it has re-initiated dosing in the single-agent clinical trial of CUDC-427 in patients with advanced and/or refractory solid tumors or lymphomas. CUDC-427 is a novel, oral small molecule that is designed to promote cancer cell death by antagonizing inhibitor of apoptosis, or IAP, proteins that support survival of cancer cells. The primary objective of the monotherapy study under the amended protocol is to determine the safety and recommended Phase 2 dose for CUDC-427 when administered orally once daily for two weeks, followed by a one week rest period in 21-day cycles until disease progression or study discontinuation. The study is expected to enroll patients in consecutive cohorts at dose levels of 100 to 300 mg per day. In addition to safety and tolerability measures, the amended protocol is designed to enroll patients in an expansion cohort, which is planned to be limited to patients with ovarian or certain hematologic cancers, including mucosa-associated lymphoid tissue lymphoma.
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