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Dose-escalating AZD1775 + Concurrent Radiation + Cisplatin for Intermediate/High Risk HNSCC

NCT02585973 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-06-29

No results posted yet for this study

Summary

This open label, single-arm, Phase 1b study is designed to identify the maximum tolerated dose (MTD) using a traditional 3+3 dose escalation design of the WEE-1 inhibitor AZD1775 when added to standard of care chemotherapy (cisplatin) and radiation for the treatment of locally advanced squamous cell cancer of the head and neck (HNSCC).

Conditions

  • Carcinoma, Squamous Cell of Head and Neck

Interventions

DRUG

AZD1775

AZD1775 given twice daily (BID) for three consecutive days (M-W) concomitantly with standard of care cisplatin and radiation. AZD1775 doses will be escalated in 50 mg increments up to 200 mg BID (M-W) in subsequent cohorts to determine the MTD.

DRUG

Cisplatin

40 mg/m2 IV infused over 1 hour D1 of each week of radiation

RADIATION

Intensity Modulated Radiotherapy Treatments

Total dose will be 70 Gy at 2Gy/fx, 35 fractions, M to Fri, for 7 weeks

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Siddharth Sheth, DO, MPH · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-26
Primary Completion
2019-06-14
Completion
2021-06-23

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02585973 on ClinicalTrials.gov