CI

At a glance

ClinicalIndex Comparison Record
Phase 1Active· 13 enrolled
Drug / intervention
Birinapant +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03803774
NCT03803774Phase 1Active

Birinapant and Intensity Modulated Re-Irradiation Therapy (IMRRT) for Locoregionally Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

National Cancer Institute (NCI)·interventional·Posted Jan 15, 2019·Updated Apr 29, 2026

In Brief

A Phase 1 clinical trial evaluating Biopsy Procedure, Birinapant, and 4 other interventions for Locally Recurrent Head and Neck Squamous Cell Carcinoma and 2 related conditions. Active but no longer recruiting, targeting 13 participants across 33 sites.

Detailed Summary

This phase I trial studies the side effects and best dose of birinapant when given together with intensity modulated re-irradiation therapy (IMRRT) in treating patients with head and neck squamous cell carcinoma that has come back at or near the same place as the original (primary) tumor (locally recurrent). Birinapant may stop the growth of tumor cells by blocking inhibitor of apoptosis (IAP), a protein needed for tumor cell survival. IMRRT uses thin beams of radiation of different intensities that are aimed at the tumor from many angles. This type of re-irradiation therapy reduces the damage to healthy tissue near the tumor. Giving birinapant with IMRRT may lower the chance of head and neck squamous cell carcinoma growing or spreading.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1Active
20192020202120222023202420252026
First PostedJan 15, 2019
Enrollment StartSep 25, 2019
Primary CompletionNov 15, 2023
Study CompletionJul 9, 2026
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.5 years ago

Interventions

Biopsy Procedureprocedure

Undergo biopsy

Birinapantdrug

Given IV

Computed Tomographyprocedure

Undergo CT scan

Intensity-Modulated Radiation Therapyradiation

Undergo IMRRT

Magnetic Resonance Imagingprocedure

Undergo MRI

Positron Emission Tomographyprocedure

Undergo PET scan