About the Phase I Combination TrialThe Phase I clinical trial is designed as an open-label, dose escalation study in which a total of approximately 15-25 human papillomavirus negative (HPV-) locally advanced head and neck cancer patients will be treated with CUDC-101 in combination with cisplatin and radiation at four study centers in the United States. The primary objective of this study is to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 in this patient population. Secondary objectives are to (i) evaluate the efficacy of CUDC-101, cisplatin and radiation therapy combination, (ii) assess the pharmacokinetics of CUDC-101, and (iii) evaluate tumor markers for response associated with CUDC-101, cisplatin and radiation activity. CUDC-101 will be administered three times per week for 8 consecutive weeks, with a beginning dose of 225 milligrams per meter 2. The MTD of CUDC-101 in a previously completed single agent Phase I clinical trial was established as 275 milligrams per meter 2.
Curis Announces Dosing Of First Patient In Phase I CUDC-101 Head And Neck Cancer Combination Trial
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