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Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

NCT05057247 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-10-31

Study results available
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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

Conditions

  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Recurrent Squamous Cell Carcinoma of the Head and Neck
  • Metastatic Head and Neck Cancer
  • Advanced Head and Neck Cancer
  • Advanced Head and Neck Squamous Cell Carcinoma

Interventions

DRUG

Duvelisib

Duvelisib capsules should be swallowed whole with a glass of water (approximately 8 ounces). Advise patients not to open, break, or chew the capsules. Duvelisib may be administered without regard to meals; however, subjects should avoid grapefruit and grapefruit juice while on duvelisib. continue for up to 24 months.

DRUG

Docetaxel

Docetaxel chemotherapy once every 21 days (by intravenous infusion) over about 30- 60 minutes at each visit. This will continue for up to 24 months

Sponsors & Collaborators

  • Secura Bio, Inc.

    collaborator INDUSTRY

  • Glenn J. Hanna

    lead OTHER

Principal Investigators

  • Glenn J. Hanna, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2023-10-01
Completion
2024-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05057247 on ClinicalTrials.gov