Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

Status Active, not recruiting

Clinical Trial 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

Clinical Trial Description

This multicenter, phase II open-label, single-arm trial will enroll participants with recurrent or metastatic (R/M), incurable squamous cell carcinoma of the head and neck (SCCHN) who have failed or discontinued PD-1 blockade in the first-line (1L) advanced disease setting, regardless of human papillomavirus (HPV) and smoking status, or PI3K pathway alteration status. This research study involves the oral (taken by mouth) agent duvelisib with the intravenous (IV) chemotherapy agent docetaxel. The names of the study drugs involved in this study are: - Duvelisib (PI3K inhibitor) - Docetaxel chemotherapy The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. Participants will receive study treatment for up to 2 years and will be followed for 3 years. It is expected that about 30 people will take part in this research. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug (duvelisib) to learn whether it works in treating a specific disease. "Investigational" means that the drug is being studied. The U.S. Food and Drug Administration (FDA) has not approved duvelisib for this specific disease but has approved it for other uses (such as certain types of blood cancers). The FDA has approved docetaxel as a treatment option for head and neck cancer, as well as other cancer types. ;

Study Design

Related Conditions & MeSH terms

Advanced Head and Neck Cancer
Advanced Head and Neck Squamous Cell Carcinoma
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Metastatic Head and Neck Cancer
Recurrence
Squamous Cell Carcinoma of Head and Neck
Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Clinical Trial Details

NCT number	NCT05057247
Study type	Interventional
Source	Dana-Farber Cancer Institute
Contact
Status	Active, not recruiting
Phase	Phase 2
Start date	October 14, 2021
Completion date	January 1, 2025

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.