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A Phase I Study of VX-970 in Combination with Cisplatin and XRT in Patients with Locally Advanced HPV (-) Head and Neck Squamous Cell Carcinoma (HNSCC; SDC 10060121)

Status
Active
Cancer Type
Head and Neck Cancer
Oral Cancer
Trial Phase
Phase I
Eligibility
18 and over, Male and Female
Study Type
Biomarker/Laboratory analysis
Treatment
NCD ID
NCT02567422
Protocol IDs
9950 (primary)
NCI-2015-01643
Study Sponsor
National Cancer Institute

Summary

This phase I trial studies the side effects and best dose of ATR kinase inhibitor VX-970 (VX-970) when given together with cisplatin and radiation therapy in treating patients with human papillomavirus negative (HPV) (-) head and neck squamous cell carcinoma that has spread from where it started to nearby tissue or lymph nodes. ATR kinase inhibitor VX-970 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving ATR kinase inhibitor VX-970 together with cisplatin and radiation therapy may work better in treating patients with locally advanced HPV- negative head and neck squamous cell carcinoma.

Objectives

PRIMARY OBJECTIVES:

I. Assess the safety and tolerability of VX-970 when administered along with weekly cisplatin and radiation therapy (XRT) in patients with locoregionally advanced HPV (-) head and neck squamous cell carcinoma (HNSCC).

II. Establish the recommended phase 2 dose (RP2D) of the combination.

SECONDARY OBJECTIVES:

I. Characterize the pharmacokinetic (PK) profile of VX-970.

II. To observe and record anti-tumor activity.

III. To assess the rate of complete metabolic response at 12 weeks post completion of chemoradiation.

IV. To conduct exploratory analysis for association between tissue-based biomarkers and clinical outcome.

OUTLINE: This is a dose-escalation study of ATR kinase inhibitor VX-970.

Patients receive ATR kinase inhibitor VX-970 intravenously (IV) over 60 minutes on day -7 and then weekly on day 2 and cisplatin IV over 30-60 minutes weekly on day 1. Patients also undergo radiation therapy once daily, 5 days a week. Treatment continues for up to 7 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days .and then every 3 months for 2 years.

Treatment Sites in Georgia

Emory University Hospital - Midtown


550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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