Numerous clinical trials evaluate selumetinib across diverse oncology and genetic indications, notably neurofibromatosis type 1—including plexiform neurofibromas, cutaneous neurofibromas, and optic nerve gliomas—as well as papillary thyroid carcinoma, biliary tract carcinoma, sarcomas, and advanced solid tumors. Spanning Early Phase 1 through Phase 3, these studies encompass actively recruiting, completed, and market-approved trials. Investigations are broadly supported by industry sponsors, including AstraZeneca and Merck Sharp & Dohme, alongside major public institutions such as the National Cancer Institute and the United States Department of Defense.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07713745 | NOT_YET_RECRUITING | Neurofibromatosis Type 2; Vestibular Schwannoma; Non-vestibular Schwannoma; Meningioma; Ependymoma; NF2-related Schwannomatosis; NF2 |
Beijing Tiantan Hospital |
2026-07-18 | PHASE2 |
| NCT06502171 | RECRUITING | Neurofibromatosis 1; Plexiform Neurofibroma |
Girish Dhall, MD |
2026-06-09 | PHASE1 |
| NCT05253131 | RECRUITING | MPNST; NF1; Sarcoma |
University of Alabama at Birmingham |
2026-08-04 | PHASE2 |
| NCT06188741 | RECRUITING | Neurofibromatosis 1; Plexiform Neurofibroma |
University of Alabama at Birmingham |
2025-08-27 | PHASE2 |
| NCT02813135 | RECRUITING | Pediatric Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
2016-08-03 | PHASE1; PHASE2 |
| NCT04166409 | RECRUITING | Low Grade Astrocytoma; Low Grade Glioma; Metastatic Low Grade Astrocytoma; Metastatic Low Grade Glioma; WHO Grade 1 Glioma; WHO Grade 2 Glioma |
National Cancer Institute (NCI) |
2020-01-31 | PHASE3 |
| NCT05564377 | RECRUITING | Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2023-04-07 | PHASE2 |
| NCT07707947 | NOT_YET_RECRUITING | Neurofibromatosis Type 2; NF2; NF2-related Schwannomatosis; Meningioma; Ependymoma; Vestibular Schwannoma |
Beijing Tiantan Hospital |
2026-07-15 | PHASE2 |
| NCT05554328 | ACTIVE_NOT_RECRUITING | Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma |
National Cancer Institute (NCI) |
2023-04-25 | PHASE2 |
| NCT06763315 | NOT_YET_RECRUITING | Plexiform Neurofibromas (PN) |
West China Hospital |
2025-01-01 | PHASE2 |
| NCT02407405 | ACTIVE_NOT_RECRUITING | Neurofibromatosis 1 (NF1); Plexiform Neurofibromas (PN) |
National Cancer Institute (NCI) |
2016-01-07 | PHASE2 |
| NCT03871257 | ACTIVE_NOT_RECRUITING | Low Grade Glioma; Neurofibromatosis Type 1; Visual Pathway Glioma |
National Cancer Institute (NCI) |
2020-01-15 | PHASE3 |
| NCT05309668 | ACTIVE_NOT_RECRUITING | Neurofibromatosis Type 1 |
AstraZeneca |
2022-01-21 | PHASE1; PHASE2 |
| NCT06735820 | RECRUITING | Malignant Peripheral Nerve Sheath Tumor (MPNST); Neurofibromatosis 1 (NF1); Atypical Neurofibroma |
AeRang Kim |
2026-06-01 | PHASE1; PHASE2 |
| NCT03326310 | RECRUITING | Chronic Myeloid Leukemia; Myelofibroses |
University of Chicago |
2018-09-04 | PHASE1 |
| NCT03392246 | ACTIVE_NOT_RECRUITING | Non-small Cell Lung Cancer |
Dana-Farber Cancer Institute |
2018-01-31 | PHASE2 |
| NCT02151084 | ACTIVE_NOT_RECRUITING | Biliary Tract Carcinoma; Gallbladder Carcinoma |
University Health Network, Toronto |
2014-11 | PHASE2 |
| NCT01362803 | ACTIVE_NOT_RECRUITING | Neurofibromatosis 1; Neurofibromatosis Type 1; NF1; Neurofibroma, Plexiform |
National Cancer Institute (NCI) |
2011-09-21 | PHASE1; PHASE2 |
| NCT04576117 | ACTIVE_NOT_RECRUITING | Recurrent Low Grade Astrocytoma; Recurrent WHO Grade 2 Glioma; Refractory Low Grade Astrocytoma; Refractory Low Grade Glioma; Refractory WHO Grade 1 Glioma |
National Cancer Institute (NCI) |
2021-02-16 | PHASE3 |
| NCT06621082 | NOT_YET_RECRUITING | Neurofibromatosis 1 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2024-09-30 | PHASE2 |
| NCT06620354 | NOT_YET_RECRUITING | Neurofibromatosis 1 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2024-09-30 | PHASE2 |
| NCT07619521 | NOT_YET_RECRUITING | Advanced Pancreatic Ductal Adenocarcinoma; Metastatic Pancreatic Ductal Adenocarcinoma; Stage III Pancreatic Cancer AJCC v8; Stage IV Pancreatic Cancer AJCC v8; Unresectable Pancreatic Ductal Adenocarcinoma |
National Cancer Institute (NCI) |
2026-09-08 | PHASE1; PHASE2 |
| NCT03162627 | ACTIVE_NOT_RECRUITING | Malignant Neoplasm of Breast; Malignant Neoplasms of Digestive Organs; Malignant Neoplasms of Female Genital Organs; Malignant Neoplasms of Male Genital Organs; Malignant Neoplasms of Thyroid and Other Endocrine Glands |
M.D. Anderson Cancer Center |
2017-08-04 | PHASE1 |
| NCT05825365 | WITHDRAWN | Neurofibromatosis Type 1; Plexiform Neurofibromas; Post-operative |
AstraZeneca |
2023-08-31 | PHASE2 |
| NCT01089101 | ACTIVE_NOT_RECRUITING | Low Grade Glioma; Recurrent Childhood Pilocytic Astrocytoma; Recurrent Neurofibromatosis Type 1; Recurrent Visual Pathway Glioma; Refractory Neurofibromatosis Type 1; Refractory Visual Pathway Glioma |
National Cancer Institute (NCI) |
2010-07-07 | PHASE1; PHASE2 |
| NCT03581487 | COMPLETED | Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2019-04-01 | PHASE1; PHASE2 |
| NCT03944772 | ACTIVE_NOT_RECRUITING | Non-Small Cell Lung Cancer |
AstraZeneca |
2019-06-25 | PHASE2 |
| NCT03155620 | ACTIVE_NOT_RECRUITING | Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Non-Hodgkin Lymphoma; Ann Arbor Stage IV Non-Hodgkin Lymphoma; Histiocytic Sarcoma; Juvenile Xanthogranuloma; Langerhans Cell Histiocytosis; Malignant Glioma; Recurrent Childhood Rhabdomyosarcoma; Recurrent Ependymoma; Recurrent Ewing Sarcoma; Recurrent Glioma; Recurrent Hepatoblastoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Malignant Germ Cell Tumor; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Non-Hodgkin Lymphoma; Recurrent Osteosarcoma; Recurrent Peripheral Primitive Neuroectodermal Tumor; Recurrent Primary Central Nervous System Neoplasm; Recurrent Rhabdoid Tumor; Recurrent Soft Tissue Sarcoma; Refractory Ewing Sarcoma; Refractory Glioma; Refractory Hepatoblastoma; Refractory Langerhans Cell Histiocytosis; Refractory Malignant Germ Cell Tumor; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Osteosarcoma; Refractory Peripheral Primitive Neuroectodermal Tumor; Refractory Primary Central Nervous System Neoplasm; Refractory Rhabdoid Tumor; Refractory Rhabdomyosarcoma; Rhabdoid Tumor; Stage III Osteosarcoma AJCC v7; Stage III Soft Tissue Sarcoma AJCC v7; Stage IV Osteosarcoma AJCC v7; Stage IV Soft Tissue Sarcoma AJCC v7; Stage IVA Osteosarcoma AJCC v7; Stage IVB Osteosarcoma AJCC v7; Wilms Tumor |
National Cancer Institute (NCI) |
2017-07-31 | PHASE2 |
| NCT03801369 | TERMINATED | Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma |
Gordon Mills, MD, PhD |
2018-12-12 | PHASE2 |
| NCT04924608 | ACTIVE_NOT_RECRUITING | Neurofibromatosis 1; Plexiform Neurofibroma (PN) |
AstraZeneca |
2021-11-19 | PHASE3 |
| NCT05253131 | Not yet recruiting | MPNST|NF1|Sarcoma |
University of Alabama at Birmingham|United States Department of Defense |
2024-06-15 | Phase 2 |
| NCT03095248 | TERMINATED | Neurofibromatosis 2; Vestibular Schwannoma; Meningioma; Ependymoma; Glioma |
Children's Hospital Medical Center, Cincinnati |
2017-05-08 | PHASE2 |
| NCT03326388 | COMPLETED | Neurofibromatosis Type 1; Plexiform Neurofibroma; Optic Nerve Glioma |
Great Ormond Street Hospital for Children NHS Foundation Trust |
2019-09-26 | PHASE1; PHASE2 |
| NCT06175637 | Recruiting | Neurofibroma Plexiform |
AstraZeneca |
2023-12-20 | -- |
| NCT02664935 | COMPLETED | Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma |
University of Birmingham |
2015-05-13 | PHASE2 |
| NCT04348045 | ACTIVE_NOT_RECRUITING | Metastatic Pancreatic Adenocarcinoma |
GERCOR - Multidisciplinary Oncology Cooperative Group |
2020-12-07 | PHASE2 |
| NCT03705507 | TERMINATED | Acute Lymphoblastic Leukemia; Acute Lymphoblastic Leukemia, Adult; Acute Lymphoblastic Leukemia, Pediatric; Acute Lymphoblastic Leukemia, in Relapse; Acute Lymphoblastic Leukemia Recurrent |
University of Birmingham |
2018-05-18 | PHASE1; PHASE2 |
| NCT03004105 | WITHDRAWN | Malignant Neoplasm of Respiratory and Intrathoracic Organ Carcinoma; Advanced Lung Cancer; Recurrent Nonsmall Cell Lung Cancer |
M.D. Anderson Cancer Center |
2018-05 | PHASE2 |
| NCT05891847 | Recruiting | Neurofibroma |
AstraZeneca |
2023-03-21 | -- |
| NCT02299999 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
UNICANCER |
2014-04-07 | PHASE2 |
| NCT02839720 | COMPLETED | Cutaneous Neurofibroma; Neurofibromatosis Type 1; Optic Nerve Glioma |
National Cancer Institute (NCI) |
2017-08-26 | PHASE2 |
| NCT04590235 | ACTIVE_NOT_RECRUITING | Neurofibromatosis 1; Neurofibroma Plexiform |
AstraZeneca |
2020-12-16 | PHASE1 |
| NCT03833427 | TERMINATED | Advanced/Metastatic Solid Tumors |
Merck Sharp & Dohme LLC |
2019-03-18 | PHASE1 |
| NCT03433183 | COMPLETED | Malignant Peripheral Nerve Sheath Tumors; Neurofibromatosis 1 |
Sarcoma Alliance for Research through Collaboration |
2019-10-02 | PHASE2 |
| NCT05101148 | ACTIVE_NOT_RECRUITING | Neurofibromatosis Type 1 |
AstraZeneca |
2021-07-21 | PHASE1 |
| NCT05101148 | Active not recruiting | Neurofibromatosis Type 1 |
AstraZeneca|Merck Sharp & Dohme LLC |
2021-07-21 | Phase 1 |
| NCT03213691 | COMPLETED | Advanced Malignant Solid Neoplasm; Ann Arbor Stage III Childhood Non-Hodgkin Lymphoma; Ann Arbor Stage IV Childhood Non-Hodgkin Lymphoma; Recurrent Childhood Central Nervous System Neoplasm; Recurrent Childhood Non-Hodgkin Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Neuroblastoma; Refractory Malignant Solid Neoplasm; Refractory Neuroblastoma; Refractory Non-Hodgkin Lymphoma; Refractory Primary Central Nervous System Neoplasm |
National Cancer Institute (NCI) |
2017-10-30 | PHASE2 |
| NCT04495127 | COMPLETED | Neurofibromatosis Type 1 |
AstraZeneca |
2020-08-31 | PHASE1 |
| NCT04879160 | Completed | Neurofibromatosis 1 |
National Cancer Institute (NCI)|National Institutes of Health Clinical Center (CC) |
2021-05-12 | -- |
| NCT03745989 | COMPLETED | Solid Tumors |
Merck Sharp & Dohme LLC |
2019-02-22 | PHASE1 |
| NCT01248247 | COMPLETED | Lung Cancer |
M.D. Anderson Cancer Center |
2011-06-02 | PHASE2 |
| NCT02768766 | COMPLETED | Uveal Melanoma |
Shaheer A. Khan |
2017-02-28 | PHASE1 |
| NCT02393690 | COMPLETED | Metastatic Thyroid Gland Carcinoma; Poorly Differentiated Thyroid Gland Carcinoma; Recurrent Thyroid Gland Carcinoma; Stage IV Thyroid Gland Follicular Carcinoma AJCC v7; Stage IV Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVA Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVA Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVB Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVB Thyroid Gland Papillary Carcinoma AJCC v7; Stage IVC Thyroid Gland Follicular Carcinoma AJCC v7; Stage IVC Thyroid Gland Papillary Carcinoma AJCC v7 |
Academic and Community Cancer Research United |
2015-05-04 | PHASE2 |
| NCT02503358 | COMPLETED | Stage IIIB Non-Small Cell Lung Cancer AJCC v7; Stage IV Non-Small Cell Lung Cancer AJCC v7 |
OHSU Knight Cancer Institute |
2016-07-21 | PHASE1 |
| NCT01586624 | COMPLETED | Cancer; Non Small Cell Lung Cancer |
Cancer Research UK |
2012-01-10 | PHASE1 |
| NCT02546661 | ACTIVE_NOT_RECRUITING | Muscle Invasive Bladder Cancer |
AstraZeneca |
2016-12-28 | PHASE1 |
| NCT02143466 | ACTIVE_NOT_RECRUITING | Advanced Non Small Cell Lung Cancer |
AstraZeneca |
2014-08-05 | PHASE1 |
| NCT02583542 | UNKNOWN | Triple-Negative Breast Cancer; Squamous Cell Lung Cancer; Non-squamous Cell Lung Cancer With KRAS Mutations; Non-squamous Cell Lung Cancer With Wild-type KRAS |
Queen Mary University of London |
2015-06 | PHASE1; PHASE2 |
| NCT01364051 | ACTIVE_NOT_RECRUITING | Metastatic Melanoma; Refractory Malignant Solid Neoplasm; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Malignant Solid Neoplasm |
National Cancer Institute (NCI) |
2011-05-25 | PHASE1 |
| NCT02450656 | UNKNOWN | Colorectal Neoplasms; Gastrointestinal Neoplasms; Pancreatic Neoplasms; Carcinoma, Non-Small-Cell Lung |
The Netherlands Cancer Institute |
2015-06 | PHASE1; PHASE2 |
| NCT03109301 | WITHDRAWN | Neoplasms, Nerve Tissue; Neurofibromatosis 1; Heredodegenerative Disorders, Nervous System; Peripheral Nervous System Diseases |
National Cancer Institute (NCI) |
2017-04-07 | PHASE2 |
| NCT02117167 | COMPLETED | Non-small Cell Lung Cancer Metastatic |
UNICANCER |
2014-04-23 | PHASE2 |
| NCT03649165 | COMPLETED | Neurofibromatosis Type 1 (NF1)-Related Plexiform Neurofibromas (PNs); Healthy Participants |
AstraZeneca |
2018-09-05 | PHASE1 |
| NCT03040986 | COMPLETED | KRAS NP_004976.2:p.G12R; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IV Pancreatic Cancer AJCC v6 and v7 |
National Cancer Institute (NCI) |
2017-07-21 | PHASE2 |
| NCT02586987 | COMPLETED | Lung Cancer; Melanoma; Head and Neck Carcinoma; Gastroesophageal Cancer; Breast Cancer; Pancreatic Adenocarcinoma; Colorectal Cancer; Biliary Tract Cancer |
AstraZeneca |
2015-12-28 | PHASE1 |
| NCT01843062 | TERMINATED | Differentiated Thyroid Cancer |
AstraZeneca |
2013-08-27 | PHASE3 |
| NCT02448290 | COMPLETED | Gastric Adenocarcinoma |
Samsung Medical Center |
2014-11-12 | PHASE2 |
| NCT02025114 | COMPLETED | Non-small Cell Lung Cancer (NSCLC) |
National Taiwan University Hospital |
2014-09 | PHASE1; PHASE2 |
| NCT02685657 | UNKNOWN | Triple Negative Breast Cancer |
Russian Academy of Medical Sciences |
2016-09 | PHASE2 |
| NCT02337530 | COMPLETED | Non-Small Cell Lung Cancer |
Canadian Cancer Trials Group |
2015-05-26 | PHASE2 |
| NCT01783197 | COMPLETED | Non Small Cell Lung Cancer |
Canadian Cancer Trials Group |
2013-06-04 | PHASE1 |
| NCT01146756 | COMPLETED | Non Small Cell Lung Cancer |
The Christie NHS Foundation Trust |
2010-06-04 | PHASE1 |
| NCT02188264 | COMPLETED | Recurrent Colorectal Carcinoma; Solid Neoplasm; Stage IIIA Colorectal Cancer AJCC v7; Stage IIIB Colorectal Cancer AJCC v7; Stage IIIC Colorectal Cancer AJCC v7; Stage IVA Colorectal Cancer AJCC v7; Stage IVB Colorectal Cancer AJCC v7 |
National Cancer Institute (NCI) |
2014-08-29 | PHASE1 |
| NCT00559949 | COMPLETED | Recurrent Thyroid Gland Carcinoma; Stage I Thyroid Gland Papillary Carcinoma; Stage II Thyroid Gland Papillary Carcinoma; Stage III Thyroid Gland Papillary Carcinoma; Stage IV Thyroid Gland Papillary Carcinoma |
National Cancer Institute (NCI) |
2007-12 | PHASE2 |
| NCT02179671 | COMPLETED | Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (Stage IIIB-IV) |
AstraZeneca |
2014-07-25 | PHASE2 |
| NCT01933932 | ACTIVE_NOT_RECRUITING | Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV |
AstraZeneca |
2013-09-25 | PHASE3 |
| NCT01143402 | COMPLETED | Iris Melanoma; Medium/Large Size Posterior Uveal Melanoma; Ocular Melanoma With Extraocular Extension; Recurrent Uveal Melanoma; Small Size Posterior Uveal Melanoma; Stage IV Uveal Melanoma |
National Cancer Institute (NCI) |
2010-06 | PHASE2 |
| NCT01750281 | COMPLETED | Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV |
AstraZeneca |
2012-12-18 | PHASE2 |
| NCT01809210 | COMPLETED | Locally Advanced or Metastatic NSCL Cancer Stage IIIB IV |
AstraZeneca |
2013-04-04 | PHASE1 |
| NCT01011933 | COMPLETED | Endometrial Adenocarcinoma; Endometrial Adenosquamous Carcinoma; Endometrial Clear Cell Adenocarcinoma; Recurrent Uterine Corpus Carcinoma |
National Cancer Institute (NCI) |
2009-09 | PHASE2 |
| NCT01752569 | TERMINATED | AIDS-related Kaposi's Sarcoma |
Sheffield Teaching Hospitals NHS Foundation Trust |
2012-06-15 | PHASE1; PHASE2 |
| NCT01658943 | COMPLETED | Pancreatic Acinar Cell Carcinoma; Pancreatic Ductal Adenocarcinoma; Recurrent Pancreatic Carcinoma; Stage IV Pancreatic Cancer |
National Cancer Institute (NCI) |
2012-08 | PHASE2 |
| NCT01974752 | COMPLETED | Metastatic; Uveal Melanoma |
AstraZeneca |
2014-04 | PHASE3 |
| NCT01605916 | COMPLETED | Neoplasms,; Metastatic Cancer,; Non-Small Cell Lung Cancer; Advanced Solid Malignancies |
AstraZeneca |
2012-06 | PHASE1 |
| NCT01206140 | COMPLETED | Recurrent Adult Soft Tissue Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage IV Adult Soft Tissue Sarcoma |
National Cancer Institute (NCI) |
2010-10 | PHASE2 |
| NCT02322749 | COMPLETED | Healthy Volunteers Bioequivalence or Bioavailability Study |
AstraZeneca |
2015-02 | PHASE1 |
| NCT00888134 | COMPLETED | Adult Solid Neoplasm |
National Cancer Institute (NCI) |
2009-07 | PHASE2 |
| NCT02238782 | COMPLETED | Healthy Volunteers Bioavailability Study |
AstraZeneca |
2014-10 | PHASE1 |
| NCT02063230 | COMPLETED | Solid Tumors |
AstraZeneca |
2014-03 | PHASE1 |
| NCT02056392 | COMPLETED | Solid Tumours |
AstraZeneca |
2014-03 | PHASE1 |
| NCT01949870 | TERMINATED | Inoperable Locally Advanced or Metastatic Biliary Tract Cancer |
AstraZeneca |
2013-10 | PHASE1 |
| NCT02063204 | COMPLETED | Solid Tumours |
AstraZeneca |
2014-03 | PHASE1 |
| NCT02093728 | COMPLETED | Solid Tumours |
AstraZeneca |
2014-04 | PHASE1 |
| NCT01960374 | COMPLETED | Healthy Volunteers Pharmacokinetic Study |
AstraZeneca |
2013-10 | PHASE1 |
| NCT00780676 | TERMINATED | Breast Cancer |
M.D. Anderson Cancer Center |
2009-06 | PHASE2 |
| NCT02046850 | COMPLETED | Solid Tumours |
AstraZeneca |
2014-02 | PHASE1 |
| NCT01313039 | COMPLETED | Breast Cancer |
University of Miami |
2011-02 | EARLY_PHASE1 |
| NCT01306045 | COMPLETED | Carcinoma, Non-Small-Cell Lung; Carcinoma, Small Cell Lung; Carcinoma, Thymic |
National Cancer Institute (NCI) |
2011-02-08 | PHASE2 |
| NCT01974349 | COMPLETED | Solid Tumours |
AstraZeneca |
2013-11 | PHASE1 |
| NCT01278615 | TERMINATED | Recurrent Adult Diffuse Large Cell Lymphoma |
National Cancer Institute (NCI) |
2010-12 | PHASE2 |
| NCT01029418 | TERMINATED | Hepatocellular Carcinoma |
National Cancer Centre, Singapore |
2009-11 | PHASE1; PHASE2 |
| NCT01931761 | COMPLETED | Solid Tumours |
AstraZeneca |
2013-10 | PHASE1 |
| NCT01333475 | COMPLETED | Colorectal Neoplasms |
National Cancer Institute (NCI) |
2011-03 | PHASE2 |
| NCT01160926 | TERMINATED | Rectal Cancer |
The Christie NHS Foundation Trust |
2010-07 | PHASE1 |
| NCT01229150 | COMPLETED | Non Small Cell Lung Carcinoma |
National Cancer Institute (NCI) |
2010-10-26 | PHASE2 |
| NCT00866177 | COMPLETED | Recurrent Melanoma; Stage III Skin Melanoma; Stage IV Skin Melanoma |
National Cancer Institute (NCI) |
2009-03 | PHASE2 |
| NCT01287130 | COMPLETED | Colonic Neoplasms; Cancer of the Colon; Colon Cancer; Colon Neoplasms; Colonic Cancer |
National Cancer Institute (NCI) |
2011-01-07 | PHASE1 |
| NCT00551070 | COMPLETED | Borderline Ovarian Serous Tumor; Low Grade Ovarian Serous Adenocarcinoma; Micropapillary Serous Carcinoma; Primary Peritoneal Carcinoma; Primary Peritoneal Low Grade Serous Adenocarcinoma; Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor |
National Cancer Institute (NCI) |
2007-12-17 | PHASE2 |
| NCT01859182 | WITHDRAWN | Adenocarcinoma of the Gallbladder; Adenocarcinoma With Squamous Metaplasia of the Gallbladder; Adult Primary Cholangiocellular Carcinoma; Advanced Adult Primary Liver Cancer; Cholangiocarcinoma of the Extrahepatic Bile Duct; Localized Unresectable Adult Primary Liver Cancer; Metastatic Extrahepatic Bile Duct Cancer; Recurrent Adult Primary Liver Cancer; Recurrent Extrahepatic Bile Duct Cancer; Stage II Gallbladder Cancer; Stage IIIA Gallbladder Cancer; Stage IIIB Gallbladder Cancer; Stage IVA Gallbladder Cancer; Stage IVB Gallbladder Cancer; Unresectable Extrahepatic Bile Duct Cancer |
National Cancer Institute (NCI) |
2013-01 | PHASE2 |
| NCT01519427 | TERMINATED | Recurrent Melanoma; Stage IIIA Melanoma; Stage IIIB Melanoma; Stage IIIC Melanoma; Stage IV Melanoma |
National Cancer Institute (NCI) |
2012-01 | PHASE2 |
| NCT01222689 | COMPLETED | Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer |
National Cancer Institute (NCI) |
2010-11 | PHASE2 |
| NCT01061749 | COMPLETED | Adult Solid Neoplasm |
National Cancer Institute (NCI) |
2009-11 | PHASE1 |
| NCT00970359 | COMPLETED | Thyroid Cancer |
Memorial Sloan Kettering Cancer Center |
2009-09 | |
| NCT01242605 | COMPLETED | Biliary Tract Neoplasms; Cholangiocarcinoma; Gallbladder Neoplasms |
University College, London |
2012-02 | PHASE1 |
| NCT00553332 | COMPLETED | Liver and Intrahepatic Biliary Tract Cancer; Recurrent Extrahepatic Bile Duct Cancer; Unresectable Extrahepatic Bile Duct Cancer |
National Cancer Institute (NCI) |
2007-11 | PHASE2 |
| NCT01160718 | COMPLETED | Breast Cancer |
Swiss Cancer Institute |
2010-08 | PHASE2 |
| NCT01217450 | COMPLETED | Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IVA Colon Cancer; Stage IVA Rectal Cancer; Stage IVB Colon Cancer; Stage IVB Rectal Cancer; Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2012-10 | PHASE1 |
| NCT01021748 | COMPLETED | Locally Advanced or Metastatic Solid Tumors |
Merck Sharp & Dohme LLC |
2009-11-23 | PHASE1 |
| NCT01134601 | TERMINATED | Non-Metastatic Adenocarcinoma of the Rectum |
National Cancer Institute (NCI) |
2010-05-24 | PHASE1 |
| NCT01256359 | COMPLETED | Melanoma |
University of Oxford |
2010-10 | PHASE2 |
| NCT01635023 | COMPLETED | Healthy Volunteers |
AstraZeneca |
2012-07 | PHASE1 |
| NCT01116271 | COMPLETED | Colorectal Cancer |
AstraZeneca |
2010-04 | PHASE2 |
| NCT00604721 | COMPLETED | Adult Primary Hepatocellular Carcinoma; Advanced Adult Primary Liver Cancer; Localized Unresectable Adult Primary Liver Cancer; Recurrent Adult Primary Liver Cancer |
National Cancer Institute (NCI) |
2007-11 | PHASE2 |
| NCT01166126 | TERMINATED | Mucosal Melanoma; Recurrent Melanoma; Stage IV Melanoma |
National Cancer Institute (NCI) |
2010-10 | PHASE2 |
| NCT00588809 | COMPLETED | Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Promyelocytic Leukemia (M3); Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia |
National Cancer Institute (NCI) |
2007-12 | PHASE2 |
| NCT01085214 | COMPLETED | Recurrent Plasma Cell Myeloma; Refractory Plasma Cell Myeloma |
National Cancer Institute (NCI) |
2010-03 | PHASE2 |
| NCT00936221 | COMPLETED | Melanoma |
AstraZeneca |
2009-07 | PHASE2 |
| NCT00890825 | COMPLETED | Non Small Cell Lung Cancer |
AstraZeneca |
2009-04-20 | PHASE2 |
| NCT00600496 | COMPLETED | Breast Cancer; Breast Neoplasms; Colon Cancer; Colonic Cancer; Colon Neoplasms; Lung Cancer; Melanoma; Kidney Cancer |
AstraZeneca |
2007-12-14 | PHASE1 |
| NCT00710515 | COMPLETED | Melanoma; Malignant Melanoma |
AstraZeneca |
2008-07 | PHASE1 |
| NCT00463814 | ACTIVE_NOT_RECRUITING | Tumor; Cancer |
AstraZeneca |
2007-03-08 | PHASE1 |
| NCT00372944 | COMPLETED | Pancreatic Cancer |
AstraZeneca |
2006-08 | PHASE2 |
| NCT00338130 | COMPLETED | Melanoma |
AstraZeneca |
2006-07 | PHASE2 |
| NCT00372788 | COMPLETED | Non-small Cell Lung Cancer |
AstraZeneca |
2006-08 | PHASE2 |
| NCT00514761 | COMPLETED | Metastatic Colorectal Cancer |
AstraZeneca |
2006-09 | PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-07-20)
Mechanism and Biochemical Profile
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>).
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