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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: Completed Phase 1 study of Head and Neck Squamous Cell Carcinoma, sponsored by AstraZeneca.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
To investigate prognosis-correlated immune activation due to DDR inhibition by monitoring the induction of immunologically relevant genes in tumours of patients treated with study investigational agent(s)
Conditions Studied
Interventions
- DRUG Olaparib
- DRUG Ceralasertib
Study Locations (4)
Other
- Research Site - Toulouse
- Research Site - Changhua
- Research Site - Taipei
Pennsylvania
- Research Site - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2017-09-18 |
| Est. Completion | 2021-01-20 |
| Phase | Phase 1 |
What the finished NCT03022409 record still lists
NCT03022409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 117-participant average among 124 other Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (82% lower).
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 a single indexed study location in 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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Where NCT03022409's enrollment target sits among peer trials
21 103rd of 124 higher than 21 of 124 other Head and Neck Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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