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NCT05057247 · ClinicalTrials.gov registry record · Phase 2
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC
A Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, sponsored by Glenn J. Hanna.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT05057247: Completed Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, sponsored by Glenn J. Hanna.
NCT05057247 is a Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Cancer that has completed, run by Glenn J. Hanna. The registered enrollment target is 26 participants, below the 35-participant average among 5 other Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (26% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05057247, a Phase 2 study of Advanced Head and Neck Squamous Cell Carcinoma and Metastatic Head and Neck Cancer, has completed, sponsored by Glenn J. Hanna.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This trial that is investigating a medication called duvelisib in combination with docetaxel for the treatment of squamous cell carcinoma of the head and neck (SCCHN) that has returned or spread outside the head and neck area. The names of the study drugs involved in this study are: * Duvelisib (PI3K inhibitor) * Docetaxel chemotherapy
Primary Outcome
BOR rate was defined as the proportion of participants that experienced complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target l
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Duvelisib
Study Locations (1)
Massachusetts
- Dana Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-10-14 |
| Est. Completion | 2024-06-13 |
| Phase | Phase 2 |
What the finished NCT05057247 record still lists
NCT05057247 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 35-participant average among 5 other Advanced Head and Neck Squamous Cell Carcinoma trials with a reported enrollment target (26% lower).
The record links to 5 conditions, with Advanced Head and Neck Squamous Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Docetaxel is the first listed.
NCT05057247 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05057247 about?
NCT05057247 is a clinical study titled "Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC". This trial that is investigating a medication called duvelisib in combination with docetaxel for the treatment of squamous cell carcinoma of the head and neck (SCCHN) that has returned or spread outside the head and neck area. The names of the study drugs involved in this study are: * Duvelisib (P...
What is the current status of trial NCT05057247?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2021-10-14. Estimated completion is 2024-06-13.
What conditions does trial NCT05057247 study?
This clinical trial studies the following conditions: Advanced Head and Neck Squamous Cell Carcinoma, Metastatic Head and Neck Cancer, Squamous Cell Carcinoma of the Head and Neck (SCCHN), Recurrent Squamous Cell Carcinoma of the Head and Neck, Advanced Head and Neck Cancer.
What interventions are being tested in trial NCT05057247?
The interventions under investigation include: Docetaxel (DRUG), Duvelisib (DRUG).
Who is sponsoring clinical trial NCT05057247?
This trial is sponsored by Glenn J. Hanna, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05057247 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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