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Xevinapant

Generic Name
Xevinapant
Drug Type
Small Molecule
Chemical Formula
C32H43N5O4
CAS Number
1071992-99-8
Unique Ingredient Identifier
N65WC8PXDD

Study to Assess Xevinapant in Preoperative Subjects With Recurrent High-Grade Glioma (rHGG)

Phase 1
Withdrawn
Conditions
Recurrent High-grade Glioma
Interventions
First Posted Date
2024-06-17
Last Posted Date
2024-12-04
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
12
Registration Number
NCT06463184
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Study of Xevinapant With Radiation and Chemotherapy for Patients With Head and Neck Cancer

Phase 1
Active, not recruiting
Conditions
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Head and Neck Cancer
Interventions
First Posted Date
2023-10-31
Last Posted Date
2024-06-04
Lead Sponsor
University of Chicago
Target Recruit Count
42
Registration Number
NCT06110195
Locations
🇺🇸

University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States

Testing the Addition of an Investigational Drug, Xevinapant, to Usual Radiation Therapy Plus Cisplatin/Carboplatin for Patients With Head and Neck Cancer

Phase 2
Withdrawn
Conditions
Oropharyngeal Squamous Cell Carcinoma
Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage III Hypopharyngeal Carcinoma AJCC v8
Stage III Laryngeal Cancer AJCC v8
Stage III Lip and Oral Cavity Cancer AJCC v8
Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8
Head and Neck Squamous Cell Carcinoma
Laryngeal Squamous Cell Carcinoma
Oral Cavity Squamous Cell Carcinoma
Stage IV Laryngeal Cancer AJCC v8
Interventions
Procedure: Biospecimen Collection
Procedure: Chest Radiography
Procedure: Computed Tomography
Radiation: Image Guided Radiation Therapy
Radiation: Intensity-Modulated Radiation Therapy
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
First Posted Date
2023-10-16
Last Posted Date
2024-07-25
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Registration Number
NCT06084845

Phase 1b Safety Study of Xevinapant, Weekly Cisplatin, and RT in Participants With Unresected LA SCCHN (HyperlynX)

Phase 1
Active, not recruiting
Conditions
Head and Neck Cancer
Interventions
Radiation: intensity-modulated radiation therapy (IMRT)
First Posted Date
2023-09-28
Last Posted Date
2024-07-18
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
18
Registration Number
NCT06056310
Locations
🇺🇸

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

🇺🇸

Montefiore Medical Center PRIME, Bronx, New York, United States

🇧🇪

Universitair Ziekenhuis Gent - Medical Oncology, Gent, Belgium

and more 20 locations

Study Comparing RT With Cetuximab + Xevinapant to RT With Cetuximab-placebo in Patients With Head and Neck Cancer

Phase 3
Terminated
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
Drug: Placebo
Radiation: IMRT
First Posted Date
2023-07-05
Last Posted Date
2025-05-09
Lead Sponsor
Groupe Oncologie Radiotherapie Tete et Cou
Target Recruit Count
19
Registration Number
NCT05930938
Locations
🇫🇷

Hôpital Nord Franche Compté, Montbéliard, France

Radiotherapy Plus Xevinapant in Older Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma

Phase 2
Suspended
Conditions
Locally Advanced Head and Neck Squamous Cell Carcinoma
Interventions
Drug: Placebo
First Posted Date
2023-02-13
Last Posted Date
2024-08-27
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
230
Registration Number
NCT05724602
Locations
🇧🇪

Universitair Ziekenhuis Gent, Gent, Belgium

🇸🇮

The Institute Of Oncology, Ljubljana, Slovenia

🇳🇴

Helse Bergen HF -Haukeland Hospital - Univ. Hosp, Bergen, Norway

and more 23 locations

PK Study of Xevinapant (Debio 1143) in Healthy East Asian Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2022-08-29
Last Posted Date
2023-04-27
Lead Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Target Recruit Count
24
Registration Number
NCT05519540
Locations
🇬🇧

Labcorp Clinical Research Unit Limited, Leeds, United Kingdom

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Phase 3
Active, not recruiting
Conditions
Head and Neck Cancer
Interventions
Radiation: IMRT
Drug: Placebo
First Posted Date
2022-05-23
Last Posted Date
2024-07-18
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
166
Registration Number
NCT05386550
Locations
🇺🇸

University of Pittsburgh Medical Center Health System - UPMC Department of Dermatology, Pittsburgh, Pennsylvania, United States

🇨🇳

Xiangya Hospital, Central South University, Changsha, China

🇨🇳

Union Hospital, Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China

and more 203 locations

A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: Radiolabelled Xevinapant 100 μg (IV Solution)
Drug: Radiolabelled Xevinapant 200 mg (Oral Solution)
First Posted Date
2021-07-15
Last Posted Date
2021-12-27
Lead Sponsor
Debiopharm International SA
Target Recruit Count
12
Registration Number
NCT04962724
Locations
🇬🇧

Labcorp Clinical Research Unit, Leeds, United Kingdom

A Study of Xevinapant (Debio 1143) in Combination With Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Participants With Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

Phase 3
Terminated
Conditions
Squamous Cell Carcinoma of the Head and Neck
Interventions
Radiation: Intensity Modulation Radiation Therapy (IMRT)
Drug: Placebo
First Posted Date
2020-07-07
Last Posted Date
2024-10-01
Lead Sponsor
EMD Serono Research & Development Institute, Inc.
Target Recruit Count
730
Registration Number
NCT04459715
Locations
🇺🇸

Inventa Center for Cancer Research At Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States

🇺🇸

Dana-Farber Cancer Institute, Boston, Massachusetts, United States

🇺🇦

Medical center of Yuriy Spizhenko, Soborna Vulytsia, Kyiv, Ukraine

and more 282 locations
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