A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).

PHASE1CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

September 18, 2017

Primary Completion Date

January 20, 2021

Study Completion Date

January 20, 2021

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Ceralasertib

"Ceralasertib is an oral agent and will be dosed at 160 mg. Ceralasertib tablets should be taken at the same time each day, approximately 12 hours apart (maximum ± 2 hour window) with one glass of water.~Ceralasertib is a potent, selective inhibitor of the serine/threonine-specific protein kinase, ataxia telangiectasia and Rad3-related protein (ATR), with good selectivity against other phosphatidylinositol 3-kinase-related kinase (PIKK) family members."

DRUG

Olaparib

"Olaparib is available as a green film-coated tablet containing 100 mg or 150 mg of Olaparib. Patients will be administered Olaparib orally twice daily at 300 mg bid. The Olaprib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.~Olaparib (AZD2281, KU-0059436) is a potent Polyadenosine 5'diphosphoribose \[poly (ADP ribose)\] polymerisation (PARP) inhibitor (PARP-1, -2 and -3) that is being developed as an oral therapy, both as a monotherapy (including maintenance) and for combination with chemotherapy and other anti-cancer agents."

Trial Locations (4)

100

Research Site, Taipei

15240

Research Site, Pittsburgh

31300

Research Site, Toulouse

50006

Research Site, Changhua

Sponsors

Lead Sponsor

All Listed Sponsors
lead

AstraZeneca

INDUSTRY