NCT01384799

Phase I Study of CUDC-101 With Cisplatin and Radiation in Subjects With Head & Neck Cancer

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 Head and Neck Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Curis, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I dose escalation study of CUDC-101 in combination with concurrent cisplatin and radiation therapy in patients with locally advanced head and neck cancer. CUDC-101 is a multi-targeted agent designed to inhibit epidermal growth factor receptor (EGFR), human epidermal growth factor receptor Type 2 (Her2) and histone deacetylase (HDAC). The study is designed to establish the safety, tolerability and maximum tolerated dose (MTD) of CUDC-101 when administered in combination with concurrent cisplatin and radiation over an 8-week treatment course, consisting of a one week run-in period of CUDC-101 administered alone, followed by seven weeks of combination treatment with CUDC-101, cisplatin and radiation therapy.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
DRUG	CUDC-101	CUDC-101 will be administered as a 1 hour intravenous infusion three times per week for a one week run-in (week -1) and then as part of the combination treatment on weeks 1-7. If the 225 mg/m2 dose is tolerated in the first cohort, the dose will be increased to 275 mg/m2. If the 225 mg/m2 dose is not tolerated, the dose will be decreased to 175 mg/m2. If 175 mg/m2 is not tolerated the dose will be further decreased to 150 mg/m2.
DRUG	Cisplatin	Cisplatin will be administered intravenously at a dose of 100 mg/m2 on days 2, 23 and 44 of the seven week combination treatment course.
RADIATION	Radiation Therapy	The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions per week. The gross disease sites will receive 70 Gy in 35 fractions over seven weeks and the subclinical disease sites will receive 56 Gy in 35 fractions, again over seven weeks.

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-09-01
• Completion: 2013-10-01
• First posted: 2011-06-29
• Last updated: 2018-02-22

Locations

7 sites across 1 country: United States