Trials / Terminated
TerminatedNCT06110195
Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer
A Phase I Study of Xevinapant With Radiation and Concurrent Carboplatin and Paclitaxel in Patients Ineligible for Cisplatin With Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- University of Chicago · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to determine the best safe dose of xevinapant that can be given in combination with chemotherapy and radiation in patients with head and neck cancer. Up to 4 doses of xevinapant will be tested in the dose escalation portion of the study. After the best safe dose is found during escalation, an additional group of participants will be enrolled at that dose to learn more about the treatment combination (dose expansion). The main question\[s\] it aims to answer are: * what is the maximum safe dose that can be given * what dose should be used in subsequent (phase 2) trials Participants will receive xevinapant in combination with paclitaxel and carboplatin chemotherapy and radiation. Treatment will be given in 3-week cycles for 3 cycles.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Xevinapant | Given orally during study treatment on days 1-14 of a 21-day treatment cycles. It will be given continuously during treatment with carboplatin, paclitaxel, and radiation (chemoRT). After completely of the chemoRT dosing, an additional 3 cycles of Xevinapant along will be given. |
| DRUG | Carboplatin | Given with radiation weekly for 7 doses. |
| DRUG | Paclitaxel | Given with radiation weekly for 7 doses. |
| RADIATION | Radiation Therapy | Radiation will be given together with paclitaxel and carboplatin for 7 weeks. |
Timeline
- Start date
- 2024-01-24
- Primary completion
- 2025-05-12
- Completion
- 2025-05-12
- First posted
- 2023-10-31
- Last updated
- 2026-03-31
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06110195. Inclusion in this directory is not an endorsement.