Duvelisib + Docetaxel for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

Overseen byGlenn J. Hanna, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Glenn J. Hanna

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a combination of a pill (Duvelisib) and an IV drug (Docetaxel) for patients with head and neck cancer that has come back or spread. These patients did not respond to initial treatments. Duvelisib stops cancer cells from growing, and Docetaxel kills them by preventing cell division.

Eligibility Criteria

Adults with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), who have had no more than two prior systemic therapies, one including PD-1/L1 blockade. They must not have used PI3K inhibitors before, be in good health otherwise, and agree to use contraception.

Inclusion Criteria

I am 18 years old or older.

My blood, liver, and kidney functions meet the study's health requirements.

I can provide information on my tumor's PD-L1 and HPV status.

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Exclusion Criteria

I have cancer that has spread to my brain or spinal cord.

I have not taken strong CYP3A affecting drugs or foods within 2 weeks of starting duvelisib.

I am not taking any other cancer treatments or experimental drugs during this study.

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Treatment Details

Interventions

Docetaxel (Chemotherapy)
Duvelisib (PI3K inhibitor)

Trial OverviewThe trial is testing duvelisib combined with docetaxel chemotherapy in patients with SCCHN that has returned or spread. Duvelisib is a PI3K inhibitor which may help stop cancer growth by targeting specific cells.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Duvelisib plus Docetaxel chemotherapyExperimental Treatment2 Interventions

Participants will receive duvelisib by mouth twice daily,dosage per protocol continuously (days 1-21 of a 21-day cycle) with a 7-day lead-in planned prior to the start of taxane therapy. Docetaxel at via IV will be delivered on day 1 of each 21-day cycle. Treatment will continue for 24-months or until unacceptable toxicity, progression, or death.

Docetaxel is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Taxotere for: