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).

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
AstraZeneca
Study ID
NCT03022409
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Ceralasertib — DRUG
    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.
  • Olaparib — DRUG
    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.

Study Details

This biomarker study has been designed to assess the effects of different agents in both tumour tissue and peripheral samples to help inform the best combinations of DDR agents with immuno-oncology (IO) therapies. In the first instance 2 DDR agents will be assessed separately as monotherapy. Additional arms may be added later to evaluate other DDR agents and/or DDR and immunotherapy agents in combination or in sequence. The primary objective of the study is to investigate immune activation due to DDR inhibition by assessing tumour and blood samples of patients treated with study investigational agent(s).

Key Dates

Start date
Sep 18, 2017
Status verified
Aug 2021
Primary completion
Jan 20, 2021
Completion
Jan 20, 2021

Study Design

Enrollment
21 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: AZD6738
    AZD6738 (160 mg) tablet twice daily continuous dosing for a minimum of 9 days and a maximum of 21 days.
  • Experimental: Olaparib
    Olaparib (300 mg) tablets administered orally twice daily continuously for a minimum of 9 days and a maximum of 21 days.

Primary Outcome Measure

Conversion of an immunologically based 25-gene signature from a prognostically unfavourable state to a prognostically favourable state. [ Time Frame: From baseline through Day 31 (Follow up) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Research SitePittsburghPennsylvania15240-

Find similar trials in Pittsburgh, PA

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Research Site· Pittsburgh, PA

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