Preclinical studies demonstrated antitumor efficacy of GDC-0917 (CUDC-427) alone or in combination with other anticancer agents including chemotherapy. In October 2010, Genentech initiated an open-labeled, uncontrolled, dose-escalation, Phase I clinical study of GDC-0917 (NCT01226277; IAM4914g) in patients with refractory solid tumors or lymphoma. The study was designed to assess safety, tolerability and pharmacokinetics of daily, oral doses of GDC-0917. The presentation at ASCO focused on results from this Phase I trial, in which oral GDC-0917 was administered once daily for two weeks on and one week off treatment schedule.Forty two patients were enrolled across 11 cohorts, in which patients received GDC-0917 at doses ranging between 5 mg - 600 mg daily. Unconfirmed complete responses were observed in one ovarian cancer patient and one patient with MALT lymphoma. In addition, a mixed response was observed in one patient with a carcinoma of unknown primary origin and stable disease was observed for greater than three months in four additional patients. GDC-0917 drug levels in patient plasma were dose-proportional with an average half-life of approximately four to eight hours. No apparent drug accumulation was seen at steady state levels. Biomarker changes in the peripheral blood cells (at all dose levels) and in tumor biopsies analyzed (n=2) were consistent with the drug candidate's mechanism of action.
Curis Announces CUDC-427 (GDC-0917) Phase I Clinical Data Presented At ASCO 2013 Annual Meeting
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