A Phase I Dose Escalation Study to Investigate the Safety and Pharmacokinetics of Intravenous CUDC-101 with Concurrent Cisplatin and Radiation Therapy in Subjects with Locally Advanced Human Papillomavirus Negative Head and Neck Cancer.

Objective

This study hopes to learn more about an investigational drug called CUDC-101. "Investigational" means that CUDC-101 is being tested and has not been approved by the U.S. Food and Drug Administration (FDA). The purpose of this study is to establish the safety and tolerability of CUDC-101, when given in combination with Cisplatin and radiation therapy. Radiation therapy and Cisplatin are FDA approved and commercially available for the treatment of this disease. However, their use together with the study drug in this study is investigational.

IRB Protocol Number

11-0557

Principal Investigator(s)

ANTONIO JIMENO

Cancer Trials

• Head and Neck Cancers

Sponsor(s)

Curis, Inc.

Contact

MORGAN PITTMAN at 720-848-0442
or MORGAN.PITTMAN@UCDENVER.EDU

Eligibility and Other Participant Information

What To Expect : A screening period will determine eligibility. The treatment period will be a total of 8 weeks followed by a 12 month follow up period. The follow up period will consist of clinic visits and phone calls. // Eligibility criteria include but are not limited to 18 years or older with human papillomavirus (HPV) negative squamous cell carcinoma of the head and neck.