MedPath

Sonidegib

Generic Name
Sonidegib
Brand Names
Odomzo
Drug Type
Small Molecule
Chemical Formula
C26H26F3N3O3
CAS Number
956697-53-3
Unique Ingredient Identifier
0RLU3VTK5M
Background

Sonidegib is a Hedgehog signaling pathway inhibitor (via smoothened antagonism) developed as an anticancer agent by Novartis. It was FDA approved in 2015 for the treatment of basal cell carcinoma.

Indication

用于治疗那些在手术后或放射治疗后出现病情复发,或是不适合采用手术或放射治疗的局部晚期基底细胞癌(BCC)患者。BCC是常见皮肤癌,占所有非黑色素瘤病例的80%。

Associated Conditions
Refractory, locally advanced Basal cell carcinoma

Sonidegib in Adult Patients with Locally Advanced Basal Cell Carcinoma (laBCC) in China

Phase 4
Active, not recruiting
Conditions
Carcinoma, Basal Cell (BCC)
Interventions
First Posted Date
2025-03-18
Last Posted Date
2025-03-18
Lead Sponsor
Jemincare
Target Recruit Count
160
Registration Number
NCT06880848
Locations
🇨🇳

Peking University First Hospital, Beijing, China

AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma

Phase 2
Recruiting
Conditions
Hepatocellular Carcinoma
Interventions
First Posted Date
2022-12-30
Last Posted Date
2025-04-25
Lead Sponsor
University of Florida
Target Recruit Count
12
Registration Number
NCT05669339
Locations
🇺🇸

University of Florida, Gainesville, Florida, United States

Oral Hedgehog Inhibitors in the Treatment of Basal Cell Carcinoma in the Netherlands: a Prospective Registration Study

Recruiting
Conditions
Basal Cell Carcinoma
Locally Advanced Basal Cell Carcinoma
Basal Cell Nevus Syndrome
Metastatic Basal Cell Carcinoma
Gorlin Syndrome
Carcinoma, Basal Cell
Carcinoma
Basal Cell Tumor
Skin Cancer
Neoplasm of Skin
Interventions
First Posted Date
2022-07-19
Last Posted Date
2025-04-04
Lead Sponsor
Maastricht University Medical Center
Target Recruit Count
80
Registration Number
NCT05463757
Locations
🇳🇱

Radboudumc, Nijmegen, Gelderland, Netherlands

🇳🇱

Maastricht University Medical Center +, Maastricht, Limburg, Netherlands

🇳🇱

Amsterdam UMC, Amsterdam, Noord-Holland, Netherlands

and more 5 locations

Tailored Sonidegib Schedule After Complete Response in BCC

Phase 2
Recruiting
Conditions
Locally Advanced Basal Cell Carcinoma
Interventions
First Posted Date
2021-03-19
Last Posted Date
2022-08-04
Lead Sponsor
Gruppo Oncologico del Nord-Ovest
Target Recruit Count
21
Registration Number
NCT04806646
Locations
🇮🇹

Asst Degli Spedali Civili Di Brescia, Brescia, Italy

Personalized Risk-Adapted Therapy in Post-Pubertal Patients With Newly-Diagnosed Medulloblastoma

Phase 2
Active, not recruiting
Conditions
Medulloblastoma
Interventions
First Posted Date
2020-05-26
Last Posted Date
2024-08-26
Lead Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Target Recruit Count
20
Registration Number
NCT04402073
Locations
🇦🇺

Royal Adelaide Hospital, Adelaide, Australia

🇦🇺

Princess Alexandra Hospital - University Of Queensland, Brisbane, Australia

🇦🇺

Austin Health - Austin hospital, Melbourne, Australia

and more 47 locations

Post-authorization Safety Study on the Long Term Safety of Sonidegib in Patients With Locally Advanced Cell Carcinoma

Active, not recruiting
Conditions
Basal Cell Carcinoma
Interventions
First Posted Date
2019-08-26
Last Posted Date
2024-10-15
Lead Sponsor
Sun Pharmaceutical Industries Limited
Target Recruit Count
323
Registration Number
NCT04066504
Locations
🇮🇹

ASST Spedali Civili di Brescia, Brescia, Italy

🇩🇪

Universitaets-Hautklinik Kiel, Kiel, Germany

🇩🇪

Klinikum rechts der Isar, München, Germany

and more 44 locations

Sonidegib and Pembrolizumab in Treating Patients with Advanced Solid Tumors

Phase 1
Active, not recruiting
Conditions
Clinical Stage III Cutaneous Melanoma AJCC V8
Clinical Stage III Gastric Cancer AJCC V8
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC V8
Clinical Stage IV Cutaneous Melanoma AJCC V8
Clinical Stage IV Gastric Cancer AJCC V8
Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC V8
Locally Advanced Gastric Adenocarcinoma
Locally Advanced Gastroesophageal Junction Adenocarcinoma
Locally Advanced Urothelial Carcinoma
Metastatic Gastric Adenocarcinoma
Interventions
First Posted Date
2019-07-05
Last Posted Date
2025-03-24
Lead Sponsor
Mayo Clinic
Target Recruit Count
36
Registration Number
NCT04007744
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

🇺🇸

Mayo Clinic in Rochester, Rochester, Minnesota, United States

🇺🇸

Mayo Clinic in Florida, Jacksonville, Florida, United States

A Study to Evaluate Neoadjuvant Sonidegib Followed by Surgery or Imiquimod in the Management of Basal Cell Carcinoma

Phase 2
Recruiting
Conditions
Basal Cell Carcinoma
Basal Cell Carcinoma of Skin, Site Unspecified
Invasive Carcinoma
Skin Cancer
Interventions
Procedure: Surgery
Other: Best supportive care
First Posted Date
2018-05-23
Last Posted Date
2025-01-22
Lead Sponsor
Melanoma Institute Australia
Target Recruit Count
20
Registration Number
NCT03534947
Locations
🇦🇺

Melanoma Institute Australia, North Sydney, New South Wales, Australia

SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors

Phase 1
Completed
Conditions
Anaplastic Astrocytoma
Anaplastic Ependymoma
Anaplastic Ganglioglioma
Anaplastic Meningioma
Anaplastic Oligodendroglioma
Pleomorphic Xanthoastrocytoma, Anaplastic
Atypical Teratoid/Rhabdoid Tumor
Brain Cancer
Brain Tumor
Central Nervous System Neoplasms
Interventions
First Posted Date
2018-02-15
Last Posted Date
2024-05-31
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
68
Registration Number
NCT03434262
Locations
🇺🇸

St. Jude Children's Research Hospital, Memphis, Tennessee, United States

Pilot Study of Sonidegib and Buparlisib in Treating Patients With Advanced or Metastatic Basal Cell Carcinoma

Phase 2
Terminated
Conditions
Carcinoma, Basal Cell
Recurrent Skin Cancer
Basal Cell Nevus Syndrome
Skin Neoplasms
Interventions
First Posted Date
2014-11-27
Last Posted Date
2019-01-29
Lead Sponsor
Anne Chang
Target Recruit Count
10
Registration Number
NCT02303041
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

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