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

Clinical Trials

Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: LDE225
Drug: Bortezomib

First Posted Date: 2014-10-02

Last Posted Date: 2017-02-16

Lead Sponsor: SCRI Development Innovations, LLC

Target Recruit Count: 7

Registration Number: NCT02254551

Locations: 🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States
🇺🇸
Oncology Hematology Care, Cincinnati, Ohio, United States
🇺🇸
Tennessee Oncology, Chattanooga, Tennessee, United States

and more 2 locations

Phase IB Trial of LDE225 and Paclitaxel in Recurrent Ovarian Cancer

Phase 1

Completed

Conditions: Recurrent Ovarian Cancer

Interventions: Drug: LDE225

First Posted Date: 2014-07-21

Last Posted Date: 2018-06-18

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 15

Registration Number: NCT02195973

Locations: 🇺🇸
University of Alabama at Birmingham, Birmingham, Alabama, United States

LDE225 + Docetaxel/Prednisone for Adv/Met Castrate Resistant Prostate Cancer w/ Disease Progression After Docetaxel

Phase 1

Withdrawn

Conditions: Prostate Cancer

Interventions: Drug: Docetaxel
Drug: Prednisone
Drug: LDE225

First Posted Date: 2014-07-08

Last Posted Date: 2019-06-19

Lead Sponsor: Martin Gutierrez

Registration Number: NCT02182622

Locations: 🇺🇸
John Theurer Cancer @ HackensackUMC, Hackensack, New Jersey, United States

LDE225 in Patients With Advanced or Metastatic Hepatocellular Carcinoma and Child-Pugh A/B7 Cirrhosis

Phase 1

Completed

Conditions: Hepatocellular Carcinoma
Cirrhosis

Interventions: Drug: LDE225

First Posted Date: 2014-05-30

Last Posted Date: 2019-03-05

Lead Sponsor: Jason K. Sicklick, M.D.

Target Recruit Count: 9

Registration Number: NCT02151864

Locations: 🇺🇸
UCSD Moores Cancer Center, La Jolla, California, United States

LDE225 + Everolimus in Advanced Gastroesophageal Adenocarcinoma

Phase 1

Completed

Conditions: Esophageal Cancer

Interventions: Drug: Everolimus
Drug: LDE 225

First Posted Date: 2014-05-15

Last Posted Date: 2020-06-11

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT02138929

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, 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

A Pre-surgical Study of LDE225 in Men With High-risk Localized Prostate Cancer

Phase 1

Completed

Conditions: Prostate Cancer

Interventions: Drug: LDE225

First Posted Date: 2014-04-11

Last Posted Date: 2019-03-07

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Target Recruit Count: 14

Registration Number: NCT02111187

Locations: 🇺🇸
Johns Hopkins Hospital, Baltimore, Maryland, United States

Sonidegib and Lenalidomide After Stem Cell Transplant in Treating Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Recurrent Plasma Cell Myeloma
Refractory Plasma Cell Myeloma

Interventions: Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Sonidegib

First Posted Date: 2014-03-13

Last Posted Date: 2021-12-03

Lead Sponsor: Mayo Clinic

Target Recruit Count: 28

Registration Number: NCT02086552

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

Phase I Trial of LDE225 for Steroid-refractory Chronic GVHD After Allogeneic HSCT

Phase 1

Terminated

Conditions: Graft Versus Host Disease

Interventions: Drug: LDE225

First Posted Date: 2014-03-13

Last Posted Date: 2018-03-19

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 17

Registration Number: NCT02086513

Locations: 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

Study of LDE225 (Sonidegib) in Combination With Docetaxel in Triple Negative (TN) Advanced Breast Cancer (ABC) Patients

Phase 1

Completed

Conditions: Advanced Breast Cancer

Interventions: Drug: LDE225
Drug: Docetaxel

First Posted Date: 2014-01-06

Last Posted Date: 2023-04-03

Lead Sponsor: Spanish Breast Cancer Research Group

Target Recruit Count: 12

Registration Number: NCT02027376

Locations: 🇪🇸
Complejo Hospitalario Universitario A Coruña, A Coruña, Spain
🇪🇸
Hospital General Universitario Gregorio Marañón, Madrid, Spain
🇪🇸
Hospital Clínico Universitario San Carlos, Madrid, Spain

and more 2 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy