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

XL888 + Vemurafenib + Cobimetinib for Unresectable BRAF Mutated Stage III/IV Melanoma

Phase 1

Active, not recruiting

Conditions: Melanoma
Skin Cancer

Interventions: Drug: XL888
Drug: Vemurafenib
Drug: Cobimetinib

First Posted Date: 2016-03-29

Last Posted Date: 2024-11-20

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 26

Registration Number: NCT02721459

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

A Study of Venetoclax in Combination With Cobimetinib and Venetoclax in Combination With Idasanutlin in Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Are Not Eligible for Cytotoxic Therapy

Phase 1

Completed

Conditions: Leukemia, Myeloid, Acute

Interventions: Drug: Cobimetinib
Drug: Idasanutlin
Drug: Venetoclax

First Posted Date: 2016-02-01

Last Posted Date: 2022-01-03

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 88

Registration Number: NCT02670044

Locations: 🇺🇸
Weill Cornell Medical College, New York, New York, United States
🇨🇦
University of Alberta Hospital, Edmonton, Alberta, Canada
🇫🇷
Institut Paoli Calmettes, Marseille, France

and more 14 locations

Single-agent Cobimetinib for Adults With Histiocytic Disorders

Phase 2

Completed

Conditions: Histiocytic Disorders

Interventions: Drug: Cobimetinib

First Posted Date: 2016-01-08

Last Posted Date: 2023-11-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 35

Registration Number: NCT02649972

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Safety and Pharmacokinetics of Cobimetinib in Pediatric and Young Adult Participants With Previously Treated Solid Tumors

Phase 1

Completed

Conditions: Solid Tumors

Interventions: Drug: Cobimetinib

First Posted Date: 2015-12-24

Last Posted Date: 2022-09-16

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 56

Registration Number: NCT02639546

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
🇺🇸
Arnold Palmer Hosp-Children, Orlando, Florida, United States

and more 14 locations

A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1

Completed

Conditions: Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma

Interventions: Drug: Cobimetinib
Drug: GDC-0994

First Posted Date: 2015-05-29

Last Posted Date: 2018-11-20

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 24

Registration Number: NCT02457793

Locations: 🇺🇸
University of Colorado, Aurora, Colorado, United States
🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Sarah Cannon Research Institute, Nashville, Tennessee, United States

and more 2 locations

Trial of Vemurafenib and Cobimetinib in Patients With Advanced BRAFV600 Mutant Melanoma

Phase 3

Withdrawn

Conditions: Melanoma

Interventions: Drug: Cobimetinib
Drug: Vemurafenib

First Posted Date: 2015-04-28

Last Posted Date: 2016-11-15

Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Registration Number: NCT02427893

Locations: 🇺🇸
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States

A Study of Cobimetinib Plus Paclitaxel, Cobimetinib Plus Atezolizumab Plus Paclitaxel, or Cobimetinib Plus Atezolizumab Plus Nab-Paclitaxel as Initial Treatment for Participants With Triple-Negative Breast Cancer That Has Spread

Phase 2

Terminated

Conditions: Breast Cancer

Interventions: Drug: Cobimetinib
Drug: Placebo
Drug: Paclitaxel
Drug: Nab-Paclitaxel
Drug: Atezolizumab

First Posted Date: 2014-12-23

Last Posted Date: 2023-04-13

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 169

Registration Number: NCT02322814

Locations: 🇺🇸
Cancer Treatment Centers of America, Newnan, Georgia, United States
🇦🇺
St John of God Murdoch Hospital; Oncology West, Murdoch, Western Australia, Australia
🇧🇪
Clinique Edith Cavell, Bruxelles, Belgium

and more 50 locations

Neoadjuvant Vemurafenib + Cobimetinib + Atezolizumab in Melanoma: NEO-VC

Phase 2

Terminated

Conditions: Malignant Melanoma

Interventions: Drug: Vemurafenib
Drug: Cobimetinib
Drug: Atezolizumab

First Posted Date: 2014-12-01

Last Posted Date: 2021-02-03

Lead Sponsor: University Hospital Tuebingen

Target Recruit Count: 47

Registration Number: NCT02303951

Locations: 🇩🇪
University hospital Tübingen, Tübingen, Germany
🇫🇷
Department of Dermatology, University Hospital of Nantes, Nantes, France
🇫🇷
Hopital Saint-Louis Hopitaux Universitaires Saint-Louis Laboisiere Fernand-Widal, Paris, France

and more 4 locations

A Study to Evaluate the Pharmacokinetics and Safety of Cobimetinib in Volunteers With and Without Liver Damage

Phase 1

Completed

Conditions: Healthy Volunteer

Interventions: Drug: cobimetinib

First Posted Date: 2014-11-24

Last Posted Date: 2016-02-19

Lead Sponsor: Genentech, Inc.

Target Recruit Count: 28

Registration Number: NCT02300025

A Study of Biomarker-Driven Therapy in Metastatic Colorectal Cancer (mCRC)

Phase 2

Completed

Conditions: Colorectal Cancer

Interventions: Drug: FOLFOX induction regimen
Drug: Fluoropyrimidine (5-FU/LV or capecitabine)
Drug: Cetuximab
Drug: Trastuzumab
Drug: Bevacizumab
Drug: Pertuzumab
Drug: Vemurafenib
Drug: Atezolizumab
Drug: Cobimetinib
Drug: 5-FU/LV
Drug: Capecitabine

First Posted Date: 2014-11-14

Last Posted Date: 2024-05-06

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 1044

Registration Number: NCT02291289

Locations: 🇦🇷
Hospital de Gastroenterologia Dr. Bonorino Udaondo ; Servicio de Oncología, Buenos Aires, Argentina
🇧🇪
Institut Jules Bordet X, Brussels, Belgium
🇧🇪
Hospital Erasme, Bruxelles, Belgium

and more 151 locations

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