Sonidegib

Generic Name: Sonidegib

Brand Names: Odomzo

Drug Type: Small Molecule

Chemical Formula: C_₂₆H_₂₆F_₃N_₃O_₃

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

Associated Therapies: -

Clinical Trials

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

Phase 1

Recruiting

Conditions: Hepatocellular Carcinoma

Interventions: Drug: Irinotecan
Drug: Sonidegib
Drug: Sorafenib

First Posted Date: 2022-12-30

Last Posted Date: 2024-12-13

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: Drug: Vismodegib
Drug: Sonidegib

First Posted Date: 2022-07-19

Last Posted Date: 2024-05-22

Lead Sponsor: Maastricht University Medical Center

Target Recruit Count: 80

Registration Number: NCT05463757

Locations: 🇳🇱
UMCG, Groningen, Netherlands
🇳🇱
Radboudumc, Nijmegen, Gelderland, Netherlands
🇳🇱
Maastricht University Medical Center +, Maastricht, Limburg, Netherlands

and more 5 locations

Tailored Sonidegib Schedule After Complete Response in BCC

Phase 2

Recruiting

Conditions: Locally Advanced Basal Cell Carcinoma

Interventions: Drug: Sonidegib

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: Drug: Cisplatin
Drug: Sonidegib
Drug: Lomustine
Drug: Vincristine
Radiation: radiotherapy

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: Drug: sonidegib

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

Recruiting

Conditions: Clinical Stage III Cutaneous Melanoma AJCC v8
Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
Clinical Stage IV Cutaneous Melanoma AJCC v8
Metastatic Lung Non-Small Cell Carcinoma
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Unresectable Malignant Solid Neoplasm
Unresectable Melanoma
Clinical Stage IV Gastric Cancer AJCC v8
Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
Locally Advanced Urothelial Carcinoma

Interventions: Biological: Pembrolizumab
Drug: Sonidegib

First Posted Date: 2019-07-05

Last Posted Date: 2024-08-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 45

Registration Number: NCT04007744

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, 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: Drug: Sonidegib
Drug: Imiquimod
Procedure: Surgery
Other: Best supportive care

First Posted Date: 2018-05-23

Last Posted Date: 2024-02-14

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: Drug: ribociclib
Drug: Gemcitabine
Drug: trametinib
Drug: sonidegib
Biological: filgrastim

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: Drug: Buparlisib
Drug: Sonidegib

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

Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies

Phase 1

Completed

Conditions: Polycythemia Vera
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Untreated Adult Acute Myeloid Leukemia
Essential Thrombocythemia
Myelodysplastic/Myeloproliferative Neoplasm
Chronic Myelomonocytic Leukemia
de Novo Myelodysplastic Syndrome
Recurrent Childhood Acute Myeloid Leukemia
Myelodysplastic Syndrome

Interventions: Drug: Azacitidine
Drug: Decitabine
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Drug: Sonidegib

First Posted Date: 2014-05-02

Last Posted Date: 2019-10-30

Lead Sponsor: Mayo Clinic

Target Recruit Count: 63

Registration Number: NCT02129101

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

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