NCT01115790

A Phase 1 Study in Participants With Advanced Cancer

A Phase 1 Study of LY2606368 in Patients With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of Parts A and B of this study is to evaluate the safety and toxicity of prexasertib (an inhibitor of checkpoint kinase 1\[chk 1\]) in participants with advanced or metastatic cancer (Part A), or squamous cell cancer of the head and neck or squamous cell cancer of any tumor type (Part B). Part C of the study will evaluate prexasertib in three different groups of participants; those with squamous cell cancer of the head and neck that has recurred or spread to other parts of the body, those with squamous non-small cell lung cancer that has recurred or spread, and those with squamous cell cancer of the anus that is not curable by existing therapy.

Detailed description

Part C added per protocol amendment (February, 2013).

Conditions

• Advanced Cancer
• Squamous Cell Carcinoma
• Carcinoma, Squamous Cell of Head and Neck
• Lung Squamous Cell Carcinoma Stage IV
• Anal Squamous Cell Carcinoma
• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	Prexasertib	Prexasertib IV on day 1 of a 14 day cycle. The expected duration is 3 cycles (2 weeks each for a total of 6 weeks). Participants receiving clinical benefit may remain on study until disease progression, unacceptable toxicity or other criteria for discontinuation are met.

Timeline

• Start date: 2010-02-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2010-05-04
• Last updated: 2016-05-10

Locations

5 sites across 1 country: United States