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NCT03022409 · ClinicalTrials.gov registry record · Phase 1

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).

A Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target
4
Study locations

NCT03022409 is a Phase 1 study of Head and Neck Squamous Cell Carcinoma that has completed, run by AstraZeneca. The registered enrollment target is 21 participants, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (82% lower). The trial reports 4 study locations across 2 states.

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The verdict

NCT03022409, a Phase 1 study of Head and Neck Squamous Cell Carcinoma, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target
4
Study locations

Study Summary

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).

Interventions

  • DRUG Olaparib
  • DRUG Ceralasertib

Study Locations (4)

Other

  • Research Site - Toulouse
  • Research Site - Changhua
  • Research Site - Taipei

Pennsylvania

  • Research Site - Pittsburgh

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2017-09-18
Est. Completion 2021-01-20
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT03022409

The ClinicalTrials.gov registry entry for NCT03022409 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (82% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Olaparib is the first listed.

NCT03022409 reports 4 study locations spanning 2 distinct geographic areas - top geographies include Other, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT03022409 about?

NCT03022409 is a clinical study titled "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).". 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. Additio...

What is the current status of trial NCT03022409?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2017-09-18. Estimated completion is 2021-01-20.

What conditions does trial NCT03022409 study?

This clinical trial studies the following conditions: Head and Neck Squamous Cell Carcinoma.

What interventions are being tested in trial NCT03022409?

The interventions under investigation include: Olaparib (DRUG), Ceralasertib (DRUG).

Who is sponsoring clinical trial NCT03022409?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03022409 being conducted?

This trial has 4 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.