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Therapy Name | Selumetinib |
Synonyms | |
Therapy Description |
Koselugo (selumetinib) inhibits mitogen-activated protein kinase kinases (MEK or MAPK/ERK kinases) 1 and 2, which may prevent the activation of MEK1/2-dependent effector proteins and transcription factors, reducing cellular proliferation in various cancers (PMID: 27467210). Koselugo (selumetinib) is FDA approved for use in pediatric patients of 2 years or older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Selumetinib | Koselugo | AZD6244|ARRY-142886 | MEK inhibitor (Pan) 27 MEK1 Inhibitor 27 MEK2 Inhibitor 25 | Koselugo (selumetinib) inhibits mitogen-activated protein kinase kinases (MEK or MAPK/ERK kinases) 1 and 2, which may prevent the activation of MEK1/2-dependent effector proteins and transcription factors, reducing cellular proliferation in various cancers (PMID: 27467210). Koselugo (selumetinib) is FDA approved for use in pediatric patients of 2 years or older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
BRAF fusion | pilocytic astrocytoma | sensitive | Selumetinib | Guideline | Actionable | Koselugo (selumetinib) is included in guidelines for patients with recurrent or progressive pilocytic astrocytoma harboring a BRAF fusion (NCCN.org). | detail... |
BRAF V600E | pilocytic astrocytoma | sensitive | Selumetinib | Guideline | Actionable | Koselugo (selumetinib) is included in guidelines for patients with recurrent or progressive pilocytic astrocytoma harboring BRAF V600E (NCCN.org). | detail... |
BRAF V600E | melanoma | sensitive | Selumetinib | Phase II | Actionable | In a Phase II trial, a favorable response rate to selumetinib (AZD6244) was observed in mutant BRAF but not BRAF wild-type melanoma patients (PMID: 22048237). | 22048237 |
BRAF wild-type | melanoma | no benefit | Selumetinib | Phase II | Actionable | In a Phase II trial, a favorable response rate to Koselugo (selumetinib) was observed in BRAF-mutant, but not BRAF wild-type, melanoma patients (PMID: 22048237). | 22048237 |
BRAF mutant | thyroid cancer | predicted - sensitive | Selumetinib | Phase I | Actionable | In a Phase I study, Koselugo (selumetinib) demonstrated an increase in iodine uptake and retention in a subgroup of patients with thyroid cancer that was refractory to radioiodine, including patients with BRAF and NRAS mutations (PMID: 23406027). | 23406027 |
BRAF V600E | childhood pilocytic astrocytoma | predicted - sensitive | Selumetinib | Phase I | Actionable | In a Phase I trial, Koselugo (selumetinib) treatment resulted in a sustained partial response (PR) in 36% (9/25) and stable disease in 36% (9/25) of pediatric patients with pilocytic astrocytoma harboring KIAA1549-BRAF (n=18) or BRAF V600E (n=7), with a 2-year progression-free survival of 70%, and 29% (2/7) of the patients harboring BRAF V600E achieved PR (PMID: 31151904; NCT01089101). | 31151904 |
NRAS mutant | thyroid cancer | sensitive | Selumetinib | Phase I | Actionable | In a Phase I study, selumetinib demonstrated an increase in iodine uptake and retention in a subgroup of patients with thyroid cancer that was refractory to radioiodine; including patients with BRAF and NRAS mutations disease (PMID: 23406027). | 23406027 |
HRAS act mut | Advanced Solid Tumor | no benefit | Selumetinib | Clinical Study - Cohort | Actionable | In a Phase II trial (Pediatric MATCH), Koselugo (selumetinib) treatment was tolerated but did not result in an objective response in pediatric patients with advanced solid tumors including high-grade glioma (n=8) and rhabdomyosarcoma (n=7) harboring MAPK pathway alterations including BRAF V600E (n=2), activating KRAS (n=8)/HRAS (n=1)/NRAS (n=3) or inactivating NF1 (n=7) mutations, with a 6-month progression-free survival of 15% (3/20) and 3 stable disease as best response (PMID: 35363510; NCT03213691). | 35363510 |
NRAS act mut | Advanced Solid Tumor | no benefit | Selumetinib | Clinical Study - Cohort | Actionable | In a Phase II trial (Pediatric MATCH), Koselugo (selumetinib) treatment was tolerated but did not result in an objective response in pediatric patients with advanced solid tumors including high-grade glioma (n=8) and rhabdomyosarcoma (n=7) harboring MAPK pathway alterations including BRAF V600E (n=2), activating KRAS (n=8)/HRAS (n=1)/NRAS (n=3) or inactivating NF1 (n=7) mutations, with a 6-month progression-free survival of 15% (3/20) and 3 stable disease as best response (PMID: 35363510; NCT03213691). | 35363510 |
BRAF fusion | high grade glioma | predicted - sensitive | Selumetinib | Case Reports/Case Series | Actionable | In a retrospective analysis, Koselugo (selumetinib) treatment resulted in a partial response with a tumor reduction of 52% in a patient with high grade neuroepithelial tumor harboring a BRAF fusion (PMID: 38922339; NCT01775072). | 38922339 |
BRAF mutant | melanoma | sensitive | Selumetinib | Case Reports/Case Series | Actionable | In a Phase II trial, 5 out of 6 patients with advanced melanoma exhibiting a response to Koselugo (selumetinib) had BRAF-mutant tumors (PMID: 22048237). | 22048237 |
BRAF V600E | Advanced Solid Tumor | no benefit | Selumetinib | Case Reports/Case Series | Actionable | In a Phase II trial (Pediatric MATCH), Koselugo (selumetinib) treatment was tolerated but did not result in an objective response in pediatric patients with advanced solid tumors including high-grade glioma (n=8) and rhabdomyosarcoma (n=7) harboring MAPK pathway alterations including BRAF V600E (n=2), activating KRAS (n=8)/HRAS (n=1)/NRAS (n=3) or inactivating NF1 (n=7) mutations, with a 6-month progression-free survival of 15% (3/20) and 3 stable disease as best response (PMID: 35363510; NCT03213691). | 35363510 |
MAP2K1 Q56_V60del | ovarian serous carcinoma | predicted - sensitive | Selumetinib | Case Reports/Case Series | Actionable | In a Phase II trial, Koselugo (selumetinib) treatment resulted in a complete response that lasted over 5 years with continuous treatment in a patient with serous ovarian cancer harboring MAP2K1 Q56_V60del (PMID: 26324360). | 26324360 |
BRAF V600E | thyroid cancer | sensitive | Selumetinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Selumetinib (AZD6244) inhibited growth of both parental thyroid cancer cell lines harboring BRAF V600E and those acquired Sprycel (dasatinib)-resistance in culture (PMID: 27222538). | 27222538 |
BRAF V600E | colorectal cancer | sensitive | Selumetinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Selumetinib (AZD6244) decreased tumor growth in a cell line xenograft model of colorectal cancer harboring BRAF V600E (PMID: 23942066). | 23942066 |
HRAS Q61L | lung squamous cell carcinoma | sensitive | Selumetinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Selumetinib (AZD6244) inhibited growth of a lung squamous cell carcinoma cell line harboring HRAS Q61L in culture, and inhibited tumor growth in xenograft models (PMID: 26544513). | 26544513 |
BRAF L597Q | colon adenocarcinoma | predicted - sensitive | Selumetinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited growth of tumor cells derived from the metachronous para-aortal lymph node metastasis harboring BRAF L597Q, which was resected from a patient with colon adenocarcinoma (PMID: 31704811). | 31704811 |
BRAF V600E MAP2K1 P124S | melanoma | decreased response | Selumetinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, patient-derived melanoma cells harboring BRAF V600E and MAP2K1 P124S demonstrated decreased sensitivity to Selumetinib (AZD6244) compared to cells harboring BRAF V600E alone in culture (PMID: 22197931). | 22197931 |
JAK3 M511I | T-cell acute lymphoblastic leukemia | sensitive | Selumetinib | Preclinical - Patient cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) treatment induced apoptosis and reduced cell viability of patient-derived T-cell acute lymphoblastic leukemia cell lines harboring JAK3 M511I (PMID: 35411095). | 35411095 |
BRAF L525R | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited viability of cells expressing BRAF L525R in culture (PMID: 36856908). | 36856908 |
BRAF mutant | colon cancer | predicted - sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Selumetinib (AZD6244) resulted in some reduced cell growth in colon cancer cells harboring a BRAF mutation in culture (PMID: 27655129). | 27655129 |
BRAF V600E MAP2K1 I103N | melanoma | resistant | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, expression of MAP2K1 I103N in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
BRAF V600E MAP2K1 I111N | melanoma | resistant | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, expression of MAP2K1 I111N in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
BRAF V600E MAP2K1 I99T | melanoma | resistant | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, expression of MAP2K1 I99T in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
BRAF V600E MAP2K1 L115P | melanoma | resistant | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, expression of MAP2K1 L115P in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
BRAF V600E MAP2K1 L115R | melanoma | resistant | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, expression of MAP2K1 L115R in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
BRAF V600E MAP2K1 Q56P | melanoma | resistant | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, expression of MAP2K1 Q56P in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
FGFR1 amp | lung non-small cell carcinoma | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, FGFR1 amplified non-small cell lung carcinoma cells were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR1 amp | lung squamous cell carcinoma | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, FGFR1 amplified lung squamous cell carcinoma cells were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR1 amp | lung small cell carcinoma | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, FGFR1 amplified lung small cell carcinoma cells were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR2 amp | colorectal adenocarcinoma | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, FGFR2 amplified colorectal adenocarcinoma cells were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR2 K310R FGFR2 N549K | endometrial carcinoma | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, endometrial carcinoma cells harboring both FGFR2 K310R and N549K were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR2 N549K | endometrial carcinoma | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, endometrial carcinoma cells harboring FGFR2 N549K were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR2 S252W | endometrial carcinoma | decreased response | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, endometrial carcinoma cells harboring FGFR2 S252W demonstrated decreased sensitivity to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR3 S249C | renal pelvis transitional cell carcinoma | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, renal pelvis transitional cell carcinoma cells harboring FGFR3 S249C were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
FGFR3 Y373C | myeloid neoplasm | no benefit | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, myeloma cells harboring FGFR3 Y373C were not sensitive to Selumetinib (AZD-6244) in culture (PMID: 26438159). | 26438159 |
HRAS G13R | thyroid cancer | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Selumetinib (AZD6244) inhibited growth of a thyroid cancer cell line harboring HRAS G13R in culture (PMID: 27222538). | 27222538 |
HRAS mutant | Advanced Solid Tumor | predicted - sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, human solid tumor cell lines harboring HRAS mutations demonstrated increased sensitivity to growth inhibition by Selumetinib (AZD6244) in culture compared to cell lines with wild-type HRAS (PMID: 26544513). | 26544513 |
MAP2K1 C121S | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Map2k1 C121S displayed sensitivity to the Mek inhibitor, Selumetinib (AZD6244), as demonstrated by reversal of active Map2k1 in transformed human kidney cells (PMID: 29753091). | 29753091 |
MAP2K1 D67N | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited colony formation of transformed cells expressing MAP2K1 D67N in culture (PMID: 25351745). | 25351745 |
MAP2K1 E41_L54del | lung cancer | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited growth of transformed human lung cells expressing MAP2K1 E41_L54del in culture (PMID: 32122926). | 32122926 |
MAP2K1 E41_L54del | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited growth of transformed cells expressing MAP2K1 E41_L54del in culture (PMID: 32122926). | 32122926 |
MAP2K1 F129L | ovarian serous carcinoma | resistant | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, a low grade serous ovarian cancer cell line harboring MAP2K1 F129L was resistant to treatment with Koselugo (selumetinib) in culture (PMID: 36198031). | 36198031 |
MAP2K1 F129L | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Map2k1 F129L displayed sensitivity to the Mek inhibitor, Selumetinib (AZD6244), as demonstrated by reversal of active Map2k1 in transformed human kidney cells (PMID: 29753091). | 29753091 |
MAP2K1 F53L | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited colony formation of transformed cells expressing MAP2K1 F53L in culture (PMID: 25351745). | 25351745 |
MAP2K1 F53L | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Map2k1 F53L displayed sensitivity to the Mek inhibitor, Selumetinib (AZD6244), as demonstrated by reversal of active Map2k1 in transformed human kidney cells (PMID: 29753091). | 29753091 |
MAP2K1 I111S | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Map2k1 I111S displayed sensitivity to the Mek inhibitor, Selumetinib (AZD6244), as demonstrated by reversal of active Map2k1 in transformed human kidney cells (PMID: 29753091). | 29753091 |
MAP2K1 K57N | lung adenocarcinoma | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited phosphorylation of ERK in cells expressing MAP2K1 K57N and inhibited MAP2K1 K57N-dependent growth in cell culture (PMID: 18632602). | 18632602 |
MAP2K1 K57N | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited colony formation of transformed cells expressing MAP2K1 K57N in culture (PMID: 25351745). | 25351745 |
MAP2K1 K57N | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Map2k1 K57N displayed sensitivity to the Mek inhibitor, Selumetinib (AZD6244), as demonstrated by reversal of active Map2k1 in transformed human kidney cells (PMID: 29753091). | 29753091 |
MAP2K1 Q56P | stomach cancer | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited growth of a gastric cancer cell line that requires MAP2K1 Q56P and inhibited phosphorylation of ERK in these cells (PMID: 22327936). | 22327936 |
MAP2K1 Q56P | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited colony formation of transformed cells expressing MAP2K1 Q56P in culture (PMID: 25351745). | 25351745 |
MAP2K1 Q56P | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Map2k1 Q56P displayed sensitivity to the Mek inhibitor, Selumetinib (AZD6244), as demonstrated by reversal of active Map2k1 in transformed human kidney cells (PMID: 29753091). | 29753091 |
PIK3CA H1047R | colon cancer | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited viability of a colon cancer cell line expressing PIK3CA H1047R in culture (PMID: 27636997). | 27636997 |
ROS1 D2113G | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited proliferation of transformed cells expressing ROS1 D2113G in culture (PMID: 37587872). | 37587872 |
ROS1 D2113N | Advanced Solid Tumor | sensitive | Selumetinib | Preclinical - Cell culture | Actionable | In a preclinical study, Koselugo (selumetinib) inhibited proliferation of transformed cells expressing ROS1 D2113N in culture (PMID: 37587872). | 37587872 |
BRAF R506_K507insLLR | Advanced Solid Tumor | predicted - sensitive | Selumetinib | Preclinical - Biochemical | Actionable | In a preclinical study,Koselugo (selumetinib) treatment inhibited Erk signaling in cells expressing BRAF R506_K507insLLR in culture (PMID: 34108213). | 34108213 |
BRAF G469R NRAS Q61K | melanoma | decreased response | Selumetinib | Preclinical | Actionable | In a preclinical study, Selumetinib (AZD6244) modestly inhibited proliferation of human melanoma cells harboring BRAF G469R and NRAS Q61K in culture (PMID: 26343583). | 26343583 |
BRAF V600E MAP2K1 C121S | melanoma | decreased response | Selumetinib | Preclinical | Actionable | In a preclinical study, melanoma cell lines harboring BRAF V600E mutation and overexpressing MAP2K1 C121S were less sensitive than those overexpressing wild-type MAP2K1 to Selumetinib (AZD6244)-induced inhibition of Mapk pathway activation and cell proliferation in culture (PMID: 24448821). | 24448821 |
BRAF V600E MAP2K1 H119P | melanoma | resistant | Selumetinib | Preclinical | Actionable | In a preclinical study, expression of MAP2K1 H119P in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
BRAF V600E MAP2K1 P124L | melanoma | resistant | Selumetinib | Preclinical | Actionable | In a preclinical study, expression of MAP2K1 P124L in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) in culture (PMID: 19915144). | 19915144 |
BRAF V600E MAP2K1 V211D | melanoma | resistant | Selumetinib | Preclinical | Actionable | In a preclinical study, expression of MAP2K1 V211D in melanoma cells harboring BRAF V600E conferred resistance to Koselugo (selumetinib) treatment in culture (PMID: 19915144). | 19915144 |
FGFR2 amp | stomach cancer | resistant | Selumetinib | Preclinical | Actionable | In a preclinical study, Selumetinib (AZD-6244) did not inhibit growth of gastric cancer cells with FGFR2 amplification in culture (PMID: 19755509). | 19755509 |
MAP2K1 Q56P | lung adenocarcinoma | sensitive | Selumetinib | Preclinical | Actionable | In a preclinical study, a lung adenocarcinoma cell line harboring MAP2K1 Q56P demonstrated sensitivity to Selumetinib (AZD6244), resulting in decreased cell viability (PMID: 26582713). | 26582713 |
MAP2K1 V211D | Advanced Solid Tumor | resistant | Selumetinib | Preclinical | Actionable | In a preclinical study, Map2k1 V211D displayed resistance to the Mek inhibitor, Selumetinib (AZD6244), as demonstrated by constitutive activation of Map2k1 in transformed human kidney cells (PMID: 29753091). | 29753091 |
NRAS G13D | melanoma | sensitive | Selumetinib | Preclinical | Actionable | In a preclinical study, Selumetinib (AZD6244) inhibited proliferation of human melanoma cells harboring NRAS G13D in culture (PMID: 26343583). | 26343583 |
NRAS Q61K | melanoma | sensitive | Selumetinib | Preclinical | Actionable | In a preclinical study, Selumetinib (AZD6244) inhibited proliferation of human melanoma cell lines harboring NRAS Q61K in culture (PMID: 26343583). | 26343583 |
NRAS Q61L | melanoma | decreased response | Selumetinib | Preclinical | Actionable | In a preclinical study, Selumetinib (AZD6244) modestly inhibited proliferation of human melanoma cells harboring NRAS Q61L in culture (PMID: 26343583). | 26343583 |
TP53 D259Y | melanoma | sensitive | Selumetinib | Preclinical | Actionable | In a preclinical study, Selumetinib (AZD6244) inhibited proliferation of human melanoma cells harboring TP53 D259Y in culture (PMID: 26343583). | 26343583 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01089101 | Phase Ib/II | Selumetinib | Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma | Active, not recruiting | USA | 0 |
NCT01362803 | Phase Ib/II | Selumetinib | AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors | Active, not recruiting | USA | 0 |
NCT02407405 | Phase II | Selumetinib | MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas | Active, not recruiting | USA | 0 |
NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Active, not recruiting | USA | CAN | AUS | 1 |
NCT04924608 | Phase III | Selumetinib | Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas (KOMET) | Active, not recruiting | USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BRA | AUS | 3 |
NCT05101148 | Phase I | Selumetinib | Phase I Study to Assess the Effect of Food on the PK and Gastrointestinal Toxicity of Selumetinib in Adolescent Children With Neurofibromatosis Type 1 Related Plexiform Neurofibromas | Active, not recruiting | USA | POL | ESP | 1 |
NCT05309668 | Phase Ib/II | Selumetinib | Pharmacokinetics, Safety and Efficacy of the Selumetinib Granule Formulation in Children Aged >/=1 to <7 Years With NF1-related Symptomatic, Inoperable PN (SPRINKLE) | Active, not recruiting | USA | NLD | ITA | ESP | DEU | 2 |
NCT03259633 | Expanded access | Selumetinib | An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1 | Approved for marketing | USA | 0 |
NCT01306045 | Phase II | Erlotinib Lapatinib MK2206 Sunitinib Selumetinib | Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies | Completed | USA | 0 |
NCT01783197 | Phase I | Selumetinib | Study of Selumetinib in Patients With Previously Treated or Untreated Advanced/Metastatic NSCLC | Completed | CAN | 0 |
NCT02188264 | Phase I | Cyclosporine Selumetinib | Selumetinib and Cyclosporine in Treating Patients With Advanced Solid Tumors or Advanced or Metastatic Colorectal Cancer | Completed | USA | CAN | 0 |
NCT02337530 | Phase II | Selumetinib Cisplatin + Pemetrexed Disodium | Selumetinib in Patients Receiving Pemetrexed and Cisplatin in Advanced or Metastatic KRAS Wildtype or Unknown Non-Squamous Non-Small Cell Lung Cancer | Completed | CAN | 0 |
NCT02393690 | Phase II | Selumetinib | Iodine I-131 With or Without Selumetinib in Treating Patients With Recurrent or Metastatic Thyroid Cancer | Completed | USA | 0 |
NCT02768766 | Phase I | Selumetinib | Intermittent Selumetinib for Uveal Melanoma | Completed | USA | 0 |
NCT02839720 | Phase II | Selumetinib | Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma | Completed | USA | 0 |
NCT03040986 | Phase II | Selumetinib | Selumetinib Sulfate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12R Mutations | Completed | USA | 0 |
NCT03213691 | Phase II | Selumetinib | Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial) | Completed | USA | 1 |
NCT03326388 | Phase Ib/II | Selumetinib | Intermittent Dosing Of Selumetinib In Childhood NF1 Associated Tumours (INSPECT) | Completed | GBR | 0 |
NCT03871257 | Phase III | Carboplatin + Vincristine Sulfate Selumetinib | A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma | Recruiting | USA | CAN | 1 |
NCT04166409 | Phase III | Selumetinib Carboplatin + Vincristine Sulfate | A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma | Recruiting | USA | CAN | 1 |
NCT04576117 | Phase III | Selumetinib Selumetinib + Vinblastine | A Study to Compare Treatment With the Drug Selumetinib Alone Versus Selumetinib and Vinblastine in Patients With Recurrent or Progressive Low-Grade Glioma | Recruiting | USA | CAN | 0 |
NCT05554328 | Phase II | Selumetinib Olaparib + Selumetinib | Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial | Recruiting | USA | 1 |
NCT05564377 | Phase II | Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial | Recruiting | USA | 1 |
NCT01843062 | Phase III | Selumetinib | Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer | Terminated | USA | SWE | POL | ITA | FRA | DNK | DEU | BRA | 0 |
NCT03095248 | Phase II | Selumetinib | Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors (SEL-TH-1601) | Terminated | USA | 0 |
NCT03109301 | Phase II | Selumetinib | A Phase II Trial of the Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Patients With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST) | Withdrawn | 0 |
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