Cobimetinib (GDC-0973) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 597

Clinical Trials

Numerous clinical trials evaluate cobimetinib from Early Phase 1 through Phase 3 across diverse indications, notably malignant melanoma, ovarian cancer, non-small-cell lung carcinoma, and histiocytic disorders. Supported by academic institutions, hospital networks such as Assistance Publique - Hôpitaux de Paris, and pharmaceutical companies including Hoffmann-La Roche and Genentech Inc., these investigations encompass recruitment statuses ranging from actively recruiting and active not recruiting to completed, suspended, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05768178	RECRUITING	Haematological Malignancy; Melanoma; Thyroid Cancer, Papillary; Ovarian Neoplasms; Colorectal Neoplasms; Laryngeal Neoplasms; Carcinoma, Non-Small-Cell Lung; Glioma; Multiple Myeloma; Erdheim-Chester Disease; Thyroid Carcinoma, Anaplastic; Solid Tumour	Cancer Research UK	2023-03-01	PHASE2; PHASE3
NCT05722886	RECRUITING	Haematological Malignancy; Solid Tumour	Cancer Research UK	2023-03-01	PHASE2; PHASE3
NCT07449754	RECRUITING	Advanced or Metastatic Melanoma	Hanmi Pharmaceutical Company Limited	2026-02-12	PHASE2
NCT04341181	RECRUITING	Cancer; Tumors; Neoplasms; Neoplasia	Ulrik Lassen	2020-08-24	PHASE2
NCT03202940	ACTIVE_NOT_RECRUITING	Non-small Cell Lung Cancer	Massachusetts General Hospital	2017-09-14	PHASE1; PHASE2
NCT03768063	ACTIVE_NOT_RECRUITING	Cancer	Hoffmann-La Roche	2019-02-28	PHASE3
NCT03175432	ACTIVE_NOT_RECRUITING	BRAF V600 Wild Type; Clinical Stage IV Cutaneous Melanoma AJCC v8; Intracranial Melanoma; Metastatic Malignant Neoplasm in the Brain; Metastatic Melanoma; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Refractory Melanoma	M.D. Anderson Cancer Center	2017-06-15	PHASE2
NCT04931342	ACTIVE_NOT_RECRUITING	Ovarian Cancer	Hoffmann-La Roche	2021-10-07	PHASE2
NCT06813079	RECRUITING	Pancreatic Ductal Carcinoma; Advanced Cancer; Epithelial Tumor	University Health Network, Toronto	2025-04-07	PHASE2
NCT02693535	RECRUITING	Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors	American Society of Clinical Oncology	2016-03-14	PHASE2
NCT03202316	ACTIVE_NOT_RECRUITING	Recurrent Breast Inflammatory Carcinoma; Stage IV Breast Inflammatory Carcinoma	M.D. Anderson Cancer Center	2017-08-11	PHASE2
NCT02925234	RECRUITING	Cancer; Tumors; Neoplasm; Neoplasia	The Netherlands Cancer Institute	2016-08	PHASE2
NCT03181100	ACTIVE_NOT_RECRUITING	Metastatic Thyroid Gland Carcinoma; Poorly Differentiated Thyroid Gland Carcinoma; Stage IVA Thyroid Gland Anaplastic Carcinoma AJCC v8; Stage IVB Thyroid Gland Anaplastic Carcinoma AJCC v8; Stage IVC Thyroid Gland Anaplastic Carcinoma AJCC v8; Thyroid Gland Anaplastic Carcinoma; Unresectable Thyroid Gland Carcinoma	M.D. Anderson Cancer Center	2017-07-27	PHASE2
NCT03178552	ACTIVE_NOT_RECRUITING	Non-Small Cell Lung Cancer	Hoffmann-La Roche	2017-09-22	PHASE2; PHASE3
NCT04005690	RECRUITING	Locally Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma; Borderline Resectable Pancreatic Ductal Adenocarcinoma; Resectable Pancreatic Ductal Adenocarcinoma	OHSU Knight Cancer Institute	2019-08-01	EARLY_PHASE1
NCT05691504	ACTIVE_NOT_RECRUITING	Advanced Endometrial Carcinoma; Metastatic Endometrial Carcinoma; Metastatic Fallopian Tube Carcinoma; Metastatic Platinum-Resistant Ovarian Carcinoma; Metastatic Primary Peritoneal Carcinoma; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Platinum-Resistant Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Stage III Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8; Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8	National Cancer Institute (NCI)	2023-09-14	PHASE1
NCT04835805	ACTIVE_NOT_RECRUITING	Melanoma	Genentech, Inc.	2021-05-13	PHASE1
NCT03297606	RECRUITING	Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors	Canadian Cancer Trials Group	2018-03-23	PHASE2
NCT05756556	SUSPENDED	Melanoma; Malignant Melanoma	ImmVira Pharma Co. Ltd	2024-06-30	PHASE2
NCT04302025	RECRUITING	Non-small Cell Lung Cancer	Genentech, Inc.	2020-11-06	PHASE2
NCT05159245	RECRUITING	Advanced Cancer; Solid Tumor; Haematological Malignancy	Helsinki University Central Hospital	2021-12-10	PHASE2
NCT06440850	RECRUITING	Thyroid Gland Follicular Carcinoma; Thyroid Gland Oncocytic Carcinoma; Thyroid Gland Papillary Carcinoma	City of Hope Medical Center	2024-07-15	PHASE2
NCT05238831	WITHDRAWN	Advanced Breast Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Ovarian Carcinoma; Advanced Pancreatic Carcinoma; Advanced Prostate Carcinoma; Advanced Sarcoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Recurrent Adult Soft Tissue Sarcoma; Recurrent Breast Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Prostate Carcinoma; Stage II Pancreatic Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8	OHSU Knight Cancer Institute	2023-01-30	EARLY_PHASE1
NCT05441514	COMPLETED	Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	City of Hope Medical Center	2023-04-28	PHASE1
NCT04409639	ACTIVE_NOT_RECRUITING	Chronic Myelomonocytic Leukemia (CMML)	University of Utah	2021-01-12	PHASE2
NCT04079179	RECRUITING	Langerhan's Cell Histiocytosis; Juvenile Xanthogranuloma; Erdheim-Chester Disease; Rosai Dorfman Disease; Neuro-Degenerative Disease; Histiocytic Sarcoma; Histiocytic Disorders, Malignant	Carl Allen	2021-04-19	PHASE2
NCT03337698	TERMINATED	Carcinoma, Non-Small-Cell Lung	Hoffmann-La Roche	2017-12-27	PHASE1; PHASE2
NCT03281369	TERMINATED	Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma or Esophageal Carcinoma	Hoffmann-La Roche	2017-10-13	PHASE1; PHASE2
NCT05034627	COMPLETED	Locally Advanced Pancreatic Adenocarcinoma; Metastatic Pancreatic Adenocarcinoma; Stage II Pancreatic Cancer AJCC v8; Stage IIA Pancreatic Cancer AJCC v8; Stage IIB Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8	OHSU Knight Cancer Institute	2022-08-09	PHASE1
NCT05125471	COMPLETED	Arteriovenous Malformations (Extracranial)	University of Arkansas	2022-07-26	PHASE2
NCT03600701	ACTIVE_NOT_RECRUITING	Metastatic Lung Non-Small Cell Carcinoma; Recurrent Lung Non-Small Cell Carcinoma; Refractory Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8	National Cancer Institute (NCI)	2018-11-29	PHASE2
NCT03554083	COMPLETED	Clinical Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8	Mayo Clinic	2018-10-05	PHASE2
NCT03193190	COMPLETED	Pancreatic Adenocarcinoma	Hoffmann-La Roche	2017-07-05	PHASE1; PHASE2
NCT03732703	COMPLETED	Relapsed Refractory Multiple Myeloma	Multiple Myeloma Research Consortium	2019-04-01	PHASE1; PHASE2
NCT04551521	COMPLETED	Metastatic or Locally Advanced Malignancies	German Cancer Research Center	2021-10-13	PHASE2
NCT04109456	COMPLETED	Metastatic Melanoma	InxMed (Shanghai) Co., Ltd.	2020-03-16	PHASE1
NCT04216953	COMPLETED	Sarcoma,Soft Tissue	Centre Leon Berard	2020-02-12	PHASE1; PHASE2
NCT04591431	UNKNOWN	Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer	Fondazione per la Medicina Personalizzata	2020-10-07	PHASE2
NCT02060188	COMPLETED	Microsatellite Unstable Colorectal Cancer; Microsatellite Stable Colorectal Cancer; Mismatch Repair Proficient Colorectal Cancer; Mismatch Repair Deficient Colorectal Cancer	Bristol-Myers Squibb	2014-03-12	PHASE2
NCT03284502	UNKNOWN	Locally Advanced Solid Tumor; Metastatic Solid Tumor	Hanmi Pharmaceutical Company Limited	2017-05-22	PHASE1
NCT05756556	Suspended	Melanoma\|Malignant Melanoma	ImmVira Pharma Co. Ltd	2024-06-30	Phase 2
NCT04190628	TERMINATED	Advanced Solid Tumor; BRAF V600 Mutation	ABM Therapeutics Corporation	2020-06-16	PHASE1
NCT03108131	COMPLETED	Skin Squamous Cell Carcinoma; Appendix Adenocarcinoma; Rare Lesion; Locally Advanced Malignant Neoplasm; Locally Advanced Skin Squamous Cell Carcinoma; Metastatic Malignant Neoplasm; Metastatic Skin Squamous Cell Carcinoma; Metastatic Small Intestinal Adenocarcinoma; Rare Neoplastic Syndrome; Refractory Malignant Neoplasm; Stage IV Small Intestinal Adenocarcinoma AJCC v8; Unresectable Malignant Neoplasm	M.D. Anderson Cancer Center	2017-04-07	PHASE2
NCT02902029	COMPLETED	Malignant Melanoma	University Hospital, Essen	2016-11	PHASE2
NCT03363867	UNKNOWN	Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma	Peter MacCallum Cancer Centre, Australia	2018-07-10	PHASE2
NCT02036086	UNKNOWN	Melanoma	Sunnybrook Health Sciences Centre	2015-08	PHASE2
NCT04185831	UNKNOWN	Solid Tumor	Uppsala University Hospital	2020-10-20	PHASE2
NCT04941287	ACTIVE_NOT_RECRUITING	Metastatic Distal Bile Duct Adenocarcinoma; Metastatic Gallbladder Carcinoma; Metastatic Intrahepatic Cholangiocarcinoma; Recurrent Distal Bile Duct Adenocarcinoma; Recurrent Gallbladder Carcinoma; Recurrent Intrahepatic Cholangiocarcinoma; Stage IV Distal Bile Duct Cancer AJCC v8; Stage IV Gallbladder Cancer AJCC v8; Stage IV Intrahepatic Cholangiocarcinoma AJCC v8; Unresectable Liver Carcinoma	National Cancer Institute (NCI)	2021-12-15	PHASE2
NCT04722575	ACTIVE_NOT_RECRUITING	Melanoma	Fondazione Melanoma Onlus	2020-12-03	PHASE2
NCT03224767	ACTIVE_NOT_RECRUITING	BRAF V600E Mutation Present; Papillary Craniopharyngioma	Alliance for Clinical Trials in Oncology	2018-01-05	PHASE2
NCT03395899	COMPLETED	Breast Cancer; Estrogen Receptor-positive Breast Cancer	Queen Mary University of London	2017-12-21	PHASE2
NCT03695380	COMPLETED	OVARIAN CANCER	Hoffmann-La Roche	2019-01-09	PHASE1
NCT02091141	COMPLETED	Neoplasms; Solid Tumors; Biliary Cancer; Salivary Cancer; Bladder Cancer	Genentech, Inc.	2014-04-14	PHASE2
NCT03514901	UNKNOWN	Melanoma Metastatic; BRAF V600 Mutation	Intergruppo Melanoma Italiano	2018-06-18	PHASE2
NCT05768178	Recruiting	Solid Tumor\|Haematological Malignancy\|Melanoma\|Thyroid Cancer Papillary\|Ovarian Neoplasms\|Colorectal Neoplasms\|Laryngeal Neoplasms\|Carcinoma Non-Small-Cell Lung\|Glioma\|Multiple Myeloma\|Erdheim-Chester Disease\|Thyroid Carcinoma Anaplastic	Cancer Research UK\|University of Manchester\|University of Birmingham\|Royal Marsden NHS Foundation Trust\|Hoffmann-La Roche	2023-03-01	Phase 2\|Phase 3
NCT03498521	COMPLETED	Cancer of Unknown Primary Site	Hoffmann-La Roche	2018-07-10	PHASE2
NCT03430947	TERMINATED	Malignant Melanoma Stage IV; BRAF V600 Mutation; Brain Metastases	Technische Universität Dresden	2018-07-01	PHASE2
NCT04801966	TERMINATED	Cancer	Peter MacCallum Cancer Centre, Australia	2021-09-23
NCT02649972	COMPLETED	Histiocytic Disorders	Memorial Sloan Kettering Cancer Center	2016-01	PHASE2
NCT02968303	UNKNOWN	Melanoma, Malignant, of Soft Parts	Radboud University Medical Center	2017-01-27	PHASE2
NCT01843738	WITHDRAWN	BRAFV600 Mutation; Stage IV Melanoma	University of Utah	2017-06	PHASE1
NCT04214418	TERMINATED	Gastrointestinal Cancer	Columbia University	2020-02-12	PHASE1; PHASE2
NCT03989115	COMPLETED	Solid Tumor	Revolution Medicines, Inc.	2019-07-02	PHASE1; PHASE2
NCT04007848	COMPLETED	Disease or R Group Histiocytoses	Assistance Publique - Hôpitaux de Paris	2019-07-25	PHASE3
NCT02639546	COMPLETED	Solid Tumors	Hoffmann-La Roche	2016-05-20	PHASE1; PHASE2
NCT03625141	COMPLETED	Metastatic Melanoma	Hoffmann-La Roche	2018-12-13	PHASE2
NCT03312530	COMPLETED	Multiple Myeloma	Hoffmann-La Roche	2017-11-13	PHASE1; PHASE2
NCT04835805	Active not recruiting	Melanoma	Genentech Inc.	2021-05-13	Phase 1
NCT03340558	WITHDRAWN	Metastatic Colorectal Cancer	Niharika Mettu	2018-05	PHASE2
NCT03566485	TERMINATED	Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Estrogen Receptor-positive; HER2/Neu Negative	Vanderbilt-Ingram Cancer Center	2018-07-10	PHASE1; PHASE2
NCT02670044	COMPLETED	Leukemia, Myeloid, Acute	Hoffmann-La Roche	2016-03-09	PHASE1
NCT03878524	TERMINATED	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; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Hematopoietic and Lymphoid System Neoplasm; Locally Advanced Pancreatic Adenocarcinoma; Metastatic Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Pancreatic Adenocarcinoma; Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis; Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable; Primary Myelofibrosis; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Recurrent Hematologic Malignancy; Recurrent Hodgkin Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelodysplastic/Myeloproliferative Neoplasm; Recurrent Myeloproliferative Neoplasm; Recurrent Non-Hodgkin Lymphoma; Recurrent Plasma Cell Myeloma; Recurrent Small Lymphocytic Lymphoma; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Refractory Chronic Myelomonocytic Leukemia; Refractory Hematologic Malignancy; Refractory Hodgkin Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Myelodysplastic Syndrome; Refractory Myelodysplastic/Myeloproliferative Neoplasm; Refractory Non-Hodgkin Lymphoma; Refractory Plasma Cell Myeloma; Refractory Primary Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Stage II Pancreatic Cancer AJCC v8; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Stage IV Prostate Cancer AJCC v8; Unresectable Pancreatic Adenocarcinoma	OHSU Knight Cancer Institute	2020-04-01	PHASE1
NCT02414750	TERMINATED	Metastatic Melanoma	Netherlands Working Group on Immunotherapy of Oncology	2014-12	PHASE2
NCT03101254	COMPLETED	Melanoma	Dana-Farber Cancer Institute	2017-06-06	PHASE1; PHASE2
NCT03224208	TERMINATED	Melanoma; Melanoma (Skin); Melanoma Stage	Fondazione Melanoma Onlus	2018-05-17	PHASE2
NCT03201458	COMPLETED	Gallbladder Carcinoma; Metastatic Cholangiocarcinoma; Stage III Intrahepatic Cholangiocarcinoma AJCC v8; Stage IV Intrahepatic Cholangiocarcinoma AJCC v8; Unresectable Cholangiocarcinoma	National Cancer Institute (NCI)	2018-02-08	PHASE2
NCT03264066	COMPLETED	Solid Tumors	Hoffmann-La Roche	2017-11-23	PHASE2
NCT02303951	TERMINATED	Malignant Melanoma	University Hospital Tuebingen	2015-01-22	PHASE2
NCT01656642	COMPLETED	Malignant Melanoma	Genentech, Inc.	2012-08-13	PHASE1
NCT04109456	Recruiting	Metastatic Melanoma	InxMed (Shanghai) Co. Ltd.	2020-03-16	Phase 1
NCT02537600	COMPLETED	Malignant Melanoma	Center Eugene Marquis	2015-12	PHASE2
NCT01988896	COMPLETED	Solid Tumors	Hoffmann-La Roche	2013-12-27	PHASE1
NCT02721459	ACTIVE_NOT_RECRUITING	Melanoma; Skin Cancer	H. Lee Moffitt Cancer Center and Research Institute	2016-09-07	PHASE1
NCT02908672	COMPLETED	Melanoma	Hoffmann-La Roche	2017-01-13	PHASE3
NCT02583516	COMPLETED	Melanoma	Grupo Español Multidisciplinar de Melanoma	2015-06-30	PHASE2
NCT04007848	Completed	Disease or R Group Histiocytoses	Assistance Publique - Hôpitaux de Paris	2019-07-25	Phase 3
NCT02876224	COMPLETED	Colorectal Cancer	Hoffmann-La Roche	2016-09-30	PHASE1
NCT02818023	TERMINATED	Melanoma	Yana Najjar	2016-07-13	PHASE1
NCT02291289	COMPLETED	Colorectal Cancer	Hoffmann-La Roche	2015-04-17	PHASE2
NCT03178851	COMPLETED	Malignant Melanoma	Hoffmann-La Roche	2017-06-20	PHASE1
NCT03273153	TERMINATED	Advanced BRAFV600 Wild-type Melanoma	Hoffmann-La Roche	2017-12-11	PHASE3
NCT01928394	COMPLETED	Advanced or Metastatic Solid Tumors	Bristol-Myers Squibb	2013-10-24	PHASE1; PHASE2
NCT03695380	Completed	OVARIAN CANCER	Hoffmann-La Roche	2019-01-09	Phase 1
NCT02322814	TERMINATED	Breast Cancer	Hoffmann-La Roche	2015-03-12	PHASE2
NCT01876641	TERMINATED	Metastatic Melanoma; Melanoma; BRAF-mutated Metastatic Melanoma; V600EBRAF-mutated Metastatic Melanoma	Mohammed M Milhem	2013-10	PHASE1
NCT01959633	COMPLETED	Melanoma	Fondazione Melanoma Onlus	2014-04-03	PHASE1; PHASE2
NCT02788279	COMPLETED	Colorectal Cancer	Hoffmann-La Roche	2016-07-05	PHASE3
NCT03005639	WITHDRAWN	Stage IIIB-C Melanoma	Inova Health Care Services	2017-06-01	PHASE2
NCT02768207	COMPLETED	Metastatic Melanoma	Hoffmann-La Roche	2016-05-23	PHASE2
NCT03108209	COMPLETED	Phototoxicity	Michele Sayag	2016-07
NCT02457793	COMPLETED	Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma	Genentech, Inc.	2015-06-16	PHASE1
NCT02427893	WITHDRAWN	Melanoma	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2015-08	PHASE3
NCT01813214	TERMINATED	Melanoma	Georgetown University	2013-03	PHASE2
NCT02230306	TERMINATED	Active Melanoma Brain Metastases	Melissa Burgess, MD	2015-02	PHASE2
NCT01986166	COMPLETED	Neoplasms	Genentech, Inc.	2013-11	PHASE1
NCT01495988	TERMINATED	Melanoma; Metastatic Melanoma	Melanoma Research Foundation Breakthrough Consortium	2013-08	PHASE2
NCT02300025	COMPLETED	Healthy Volunteer	Genentech, Inc.	2014-08	PHASE1
NCT01562275	COMPLETED	Neoplasms	Genentech, Inc.	2012-04	PHASE1
NCT01974258	WITHDRAWN	Neoplasms	Hoffmann-La Roche	2014-02	PHASE1
NCT01689519	COMPLETED	Malignant Melanoma	Hoffmann-La Roche	2013-01-08	PHASE3
NCT02136524	COMPLETED	Healthy Volunteer	Genentech, Inc.	2014-04	PHASE1
NCT00467779	COMPLETED	Solid Tumor	Genentech, Inc.	2007-05	PHASE1
NCT00996892	TERMINATED	Solid Tumors	Genentech, Inc.	2009-11	PHASE1
NCT01271803	COMPLETED	Malignant Melanoma	Hoffmann-La Roche	2011-02-17	PHASE1
NCT01929876	COMPLETED	Healthy Participants	Genentech, Inc.	2013-07	PHASE1
NCT01711762	COMPLETED	Healthy Volunteer	Genentech, Inc.	2012-09	PHASE1
NCT01277718	COMPLETED	Healthy Volunteer	Genentech, Inc.	2011-01	PHASE1
NCT01249131	COMPLETED	Healthy Volunteers	Genentech, Inc.	2010-12-01	PHASE1
NCT01249118	COMPLETED	Healthy Volunteers	Genentech, Inc.	2010-11	PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-24)

Check the Cobimetinib (GDC-0973) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cobimetinib is a potent, highly selective inhibitor of MEK1 that binds to the enzyme and prevents downstream phosphorylation of extracellular signal-regulated kinases, thereby blocking pro-survival MAPK pathway signaling and triggering apoptosis. This targeted interruption of oncogenic signaling inhibits tumor cell proliferation, providing therapeutic utility in MAPK-driven malignancies evaluated in clinical trials such as melanoma, ovarian cancer, and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).