NCT02555644

A Study of Prexasertib (LY2606368) With Chemotherapy and Radiation in Participants With Head and Neck Cancer

A Phase 1b Trial of LY2606368 in Combination With Chemoradiation in Patients With Locally Advanced Head and Neck Squamous Cell Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to investigate the safety of prexasertib in combination with other anti-cancer drugs (cisplatin or cetuximab) and radiation therapy in participants with locally advanced head and neck cancer. The study has two parts (A and B). Participants will only enroll in one part.

Detailed description

The primary purpose of Parts A and B of this study is to determine a recommended dose level of prexasertib (an inhibitor of checkpoint kinase 1\[Chk-1\]) in combination with cisplatin and radiation therapy (Part A) or cetuximab and radiation therapy (Part B) in participants with locally advanced head and neck cancer.

Conditions

• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	Prexasertib	Administered IV
DRUG	Cisplatin	Administered IV
DRUG	Cetuximab	Administered IV
RADIATION	Intensity Modulated Radiation Therapy

Timeline

• Start date: 2016-02-24
• Primary completion: 2019-01-14
• Completion: 2019-01-14
• First posted: 2015-09-21
• Last updated: 2019-02-15

Locations

4 sites across 2 countries: United States, France