Cobimetinib

Generic Name: Cobimetinib

Brand Names: Cotellic

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₁F_₃IN_₃O_₂

CAS Number: 934660-93-2

Unique Ingredient Identifier: ER29L26N1X

Background: Cobimetinib is an orally active, potent and highly selective small molecule inhibiting mitogen-activated protein kinase kinase 1 (MAP2K1 or MEK1), and central components of the RAS/RAF/MEK/ERK signal transduction pathway. It has been approved in Switzerland and the US, in combination with vemurafenib for the treatment of patients with unresectable or metasta...

Indication: Cobimetinib is indicated in combination with vemurafenib for the treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. As a single agent, cobimetinib is also indicated for the treatment of adult patients with histiocytic neoplasms.

Associated Conditions: Histiocytic Neoplasm, Metastatic Melanoma, Unresectable Melanoma

Associated Therapies: -

Clinical Trials

Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders

Phase 2

Recruiting

Conditions: Histiocytic Sarcoma
Histiocytic Disorders, Malignant
Juvenile Xanthogranuloma
Langerhan's Cell Histiocytosis
Rosai Dorfman Disease
Erdheim-Chester Disease
Neuro-Degenerative Disease

Interventions: Drug: Cobimetinib

First Posted Date: 2019-09-06

Last Posted Date: 2024-08-28

Lead Sponsor: Carl Allen

Target Recruit Count: 90

Registration Number: NCT04079179

Locations: 🇺🇸
John Hopkins University School of Medicine, Baltimore, Maryland, United States
🇺🇸
Texas Children's Hospital, Houston, Texas, United States
🇺🇸
Children's Medical Center- UTSW, Dallas, Texas, United States

and more 8 locations

Cobimetinib for BRAF-wild-type or Mutated Histiocytoses

Phase 3

Completed

Conditions: Disease or R Group Histiocytoses

Interventions: Drug: Placebo oral tablet
Drug: Cobimetinib

First Posted Date: 2019-07-05

Last Posted Date: 2023-08-24

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Target Recruit Count: 54

Registration Number: NCT04007848

Locations: 🇫🇷
Service de Médecine interne - La Pitié Salpêtrière, Paris, France

Targeted Pathway Inhibition in Patients With Pancreatic Cancer

Early Phase 1

Recruiting

Conditions: Unresectable Pancreatic Ductal Adenocarcinoma
Metastatic Pancreatic Ductal Adenocarcinoma
Stage III Pancreatic Cancer AJCC v8
Stage IV Pancreatic Cancer AJCC v8
Locally Advanced Pancreatic Ductal Adenocarcinoma
Stage II Pancreatic Cancer AJCC v8

Interventions: Drug: Saruparib
Biological: Tremelimumab
Drug: Olaparib
Drug: Cobimetinib
Drug: Onvansertib
Drug: Azenosertib

First Posted Date: 2019-07-02

Last Posted Date: 2024-08-19

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 90

Registration Number: NCT04005690

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

Dose-Esc/Exp RMC4630 & Cobi in Relapsed/Refractory Solid Tumors & RMC4630& Osi in EGFR+ Locally Adv/Meta NSCLC

Phase 1

Completed

Conditions: Solid Tumor

Interventions: Drug: RMC-4630
Drug: Cobimetinib

First Posted Date: 2019-06-18

Last Posted Date: 2023-06-26

Lead Sponsor: Revolution Medicines, Inc.

Target Recruit Count: 113

Registration Number: NCT03989115

Locations: 🇺🇸
Honor Health Research Institute, Scottsdale, Arizona, United States
🇺🇸
City of Hope, Duarte, California, United States
🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

and more 21 locations

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Phase 1

Terminated

Conditions: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Anatomic Stage IV Breast Cancer AJCC v8
Anemia
Ann Arbor Stage III Hodgkin Lymphoma
Ann Arbor Stage III Non-Hodgkin Lymphoma
Ann Arbor Stage IV Hodgkin Lymphoma
Ann Arbor Stage IV Non-Hodgkin Lymphoma
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Castration-Resistant Prostate Carcinoma

Interventions: Drug: Abemaciclib
Drug: Abiraterone
Drug: Afatinib
Biological: Bevacizumab
Drug: Bicalutamide
Procedure: Biospecimen Collection
Drug: Bortezomib
Drug: Cabazitaxel
Drug: Cabozantinib
Drug: Capecitabine
Drug: Carboplatin
Drug: Celecoxib
Drug: Cobimetinib
Drug: Copanlisib
Drug: Dabrafenib
Drug: Dacomitinib
Drug: Darolutamide
Drug: Dasatinib
Drug: Doxorubicin
Biological: Durvalumab
Drug: Enasidenib
Drug: Entrectinib
Drug: Enzalutamide
Drug: Erlotinib
Drug: Everolimus
Drug: Fluorouracil
Drug: Idelalisib
Drug: Imatinib
Biological: Ipilimumab
Drug: Lenvatinib
Drug: Leucovorin
Drug: Lorlatinib
Drug: Losartan
Drug: Nab-paclitaxel
Drug: Neratinib
Biological: Nivolumab
Drug: Olaparib
Drug: Oxaliplatin
Drug: Palbociclib
Drug: Panobinostat
Biological: Pembrolizumab
Biological: Pertuzumab
Drug: Ponatinib
Other: Quality-of-Life Assessment
Drug: Regorafenib
Drug: Ruxolitinib
Drug: Sirolimus
Drug: Sorafenib
Drug: Sunitinib
Drug: Trametinib
Biological: Trastuzumab Emtansine
Drug: Tretinoin
Drug: Vemurafenib
Drug: Venetoclax
Drug: Vismodegib
Drug: Vorinostat

First Posted Date: 2019-03-18

Last Posted Date: 2024-03-04

Lead Sponsor: OHSU Knight Cancer Institute

Target Recruit Count: 2

Registration Number: NCT03878524

Locations: 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States

A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study

Phase 3

Recruiting

Conditions: Cancer

Interventions: Drug: Atezolizumab
Drug: Cobimetinib
Drug: Bevacizumab
Drug: Vemurafenib
Drug: Alectinib
Drug: Pembrolizumab
Drug: FAP IL2V
Drug: Sunitinib
Drug: Venetoclax
Drug: Enzalutamide
Drug: Paclitaxel
Drug: Niraparib
Drug: Cabozantinib
Drug: Pemetrexed
Drug: Emactuzumab
Drug: Rucaparib

First Posted Date: 2018-12-07

Last Posted Date: 2024-12-20

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1000

Registration Number: NCT03768063

Locations: 🇺🇸
Univ of Alabama at Birmingham; UAB Comprehensive Cancer Ctr, Birmingham, Alabama, United States
🇺🇸
HonorHealth Research Institute - Pima - Virginia G. Piper Cancer Care Network, Scottsdale, Arizona, United States
🇺🇸
University of Arkansas for Medical Sciences; Winthrop Rockefeller Cancer Institute, Little Rock, Arkansas, United States

and more 199 locations

A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer

Phase 1

Completed

Conditions: OVARIAN CANCER

Interventions: Drug: Cobimetinib
Drug: Niraparib
Drug: Atezolizumab

First Posted Date: 2018-10-04

Last Posted Date: 2023-08-14

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 77

Registration Number: NCT03695380

Locations: 🇺🇸
Medical College of Georgia; Obstetrics & Gynecolog, Augusta, Georgia, United States
🇺🇸
Stephenson Cancer Center Investigational Pharmacy, Oklahoma City, Oklahoma, United States
🇺🇸
Florida Hospital Cancer Institute; Clinical Research Department, Orlando, Florida, United States

and more 17 locations

A Study Evaluating the Safety and Efficacy of Cobimetinib Plus Atezolizumab in BRAFV600 Wild-type Melanoma With Central Nervous System Metastases and Cobimetinib Plus Atezolizumab and Vemurafenib in BRAFV600 Mutation-positive Melanoma With Central Nervous System Metastases

Phase 2

Completed

Conditions: Metastatic Melanoma

Interventions: Drug: Cobimetinib
Drug: Atezolizumab
Drug: Vemurafenib

First Posted Date: 2018-08-10

Last Posted Date: 2024-04-11

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 80

Registration Number: NCT03625141

Locations: 🇧🇷
Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro, RJ, Brazil
🇧🇷
Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda, Ijui, RS, Brazil
🇧🇷
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil

and more 19 locations

Atezolizumab and Cobimetinib in Treating Patients With Metastatic, Recurrent, or Refractory Non-small Cell Lung Cancer

Phase 2

Active, not recruiting

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Cancer AJCC v8
Refractory Lung Non-Small Cell Carcinoma

Interventions: Drug: Atezolizumab
Procedure: Biopsy
Procedure: Biospecimen Collection
Drug: Cobimetinib
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging

First Posted Date: 2018-07-26

Last Posted Date: 2024-08-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 48

Registration Number: NCT03600701

Locations: 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Emory Saint Joseph's Hospital, Atlanta, Georgia, United States

and more 15 locations

Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer

Phase 1

Terminated

Conditions: Stage III Breast Cancer
HER2/Neu Negative
Stage IV Breast Cancer
Estrogen Receptor-positive
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer

Interventions: Drug: Atezolizumab
Drug: Cobimetinib
Drug: Idasanutlin

First Posted Date: 2018-06-25

Last Posted Date: 2021-08-11

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 12

Registration Number: NCT03566485

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States

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