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Therapy Name | Selinexor |
Synonyms | |
Therapy Description |
Xpovio (selinexor) inhibits CRM1 (XPO1), preventing CRM1-mediated nuclear export of tumor suppressor proteins and potentially restoring normal tumor suppressor function (PMID: 30976603, PMID: 31793336). Xpovio (selinexor) is FDA approved for use in patients with diffuse large B cell lymphoma after two or more prior therapies, in combination with Adexone (dexamethasone) in patients with relapsed or refractory multiple myeloma after at least four prior therapies, and in combination with Velcade (bortezomib) and Adexone (dexamethasone) in patients with multiple myeloma after at least one prior therapy (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Selinexor | Xpovio | KPT-330 | Xpovio (selinexor) inhibits CRM1 (XPO1), preventing CRM1-mediated nuclear export of tumor suppressor proteins and potentially restoring normal tumor suppressor function (PMID: 30976603, PMID: 31793336). Xpovio (selinexor) is FDA approved for use in patients with diffuse large B cell lymphoma after two or more prior therapies, in combination with Adexone (dexamethasone) in patients with relapsed or refractory multiple myeloma after at least four prior therapies, and in combination with Velcade (bortezomib) and Adexone (dexamethasone) in patients with multiple myeloma after at least one prior therapy (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
TET2 del | acute myeloid leukemia | sensitive | Selinexor | Preclinical - Cell culture | Actionable | In a preclinical study, Xpovio (selinexor) induced apoptosis in TET2-knockout acute myeloid leukemia cell lines, resulting in decreased cell viability in culture (PMID: 36746437). | 36746437 |
TP53 loss | thymoma | predicted - resistant | Selinexor | Preclinical - Cell culture | Actionable | In a preclinical study, a thymoma cell line with TP53 loss demonstrated primary resistance to Selinexor (KPT-330) in culture, and reconstitution of TP53 expression resulted in increased Selinexor sensitivity (PMID: 28819023). | 28819023 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03147885 | Phase Ib/II | Selinexor | Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma | Recruiting | USA | 0 |
NCT02146833 | Phase II | Selinexor | Study of Selinexor (KPT-330) in Metastatic Castrate Resistant Prostate Adenocarcinoma | Terminated | USA | 0 |
NCT02573363 | Phase I | Cytarabine Mitoxantrone Selinexor | Selinexor With Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia | Completed | USA | 0 |
NCT03193437 | Phase II | Selinexor | Selinexor in Patients With Advanced Thymic Epithelial Tumor Progressing After Primary Chemotherapy | Terminated | USA | 0 |
NCT02536495 | Phase Ib/II | Docetaxel Selinexor | Selinexor and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Lung Cancer | Withdrawn | 0 | |
NCT04256707 | Phase Ib/II | Pembrolizumab + Selinexor Docetaxel + Selinexor Fluorouracil + Irinotecan + Leucovorin + Selinexor Selinexor | Relative Bioavailability/Bioequivalence of Different Formulations of Selinexor, the Impact of Hepatic Impairment on Selinexor Pharmacokinetics, Tolerability and Antitumor Activity of Selinexor Combination Treatment (SPRINT) | Recruiting | ISR | 0 |
NCT02471911 | Phase I | Dexamethasone Carboplatin + Etoposide + Ifosfamide + Rituximab Selinexor | KPT-330 Plus RICE for Relapsed/Refractory Aggressive B-Cell Lymphoma | Completed | USA | 0 |
NCT04421378 | Phase Ib/II | Lomustine + Selinexor Lomustine Selinexor + Temozolomide Temozolomide Selinexor | A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma | Terminated | USA | CAN | 0 |
NCT02416908 | Phase Ib/II | Selinexor Cladribine + Cytarabine + Plerixafor | Study of CLAG + Selinexor in Relapsed or Refractory Acute Myeloid Leukemia | Completed | USA | 0 |
NCT02228525 | Phase II | Selinexor | Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) in Patients With Myelodysplastic Syndromes | Completed | USA | 0 |
NCT02323880 | Phase I | Selinexor | Study of Selinexor in Pediatric Solid Tumors | Active, not recruiting | USA | 0 |
NCT05597345 | Phase II | Selinexor | Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma | Recruiting | USA | 0 |
NCT02351505 | Phase II | Selinexor | Selinexor in Treating Patients With Relapsed Small Cell Lung Cancer | Terminated | USA | 0 |
NCT02069730 | Phase I | Selinexor | A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes | Active, not recruiting | CAN | 0 |
NCT04854434 | Phase II | Trifluridine-tipiracil hydrochloride Pembrolizumab + Selinexor Selinexor | A Study to Evaluate the Safety and Efficacy of Selinexor With or Without Pembrolizumab Versus Standard of Care in Previously Treated Metastatic Colorectal Cancer With RAS Mutations | Terminated | USA | 0 |
NCT02138786 | Phase II | Selinexor | Study of Selinexor (KPT-330) in Patients With Refractory and/or Relapsed Richter's Transformation (RT) | Terminated | USA | POL | GBR | ESP | DEU | 0 |
NCT02227251 | Phase II | Selinexor | Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (SADAL) | Recruiting | USA | POL | NZL | NLD | ITA | ISR | HUN | GRC | GBR | FRA | ESP | DEU | CAN | BGR | BEL | AUT | AUS | 2 |
NCT04811196 | Phase I | Selinexor | A Study of Different Dosing Schedules of Selinexor in Sarcoma Patients | Active, not recruiting | CAN | 0 |
NCT02120222 | Phase I | Selinexor | Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery | Completed | USA | 0 |
NCT03627403 | Phase II | Selinexor | Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors (ESSENTIAL) | Active, not recruiting | USA | 0 |
NCT02299518 | Phase I | Etoposide Selinexor Cytarabine + Etoposide + Mitoxantrone | Selinexor and Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia | Completed | USA | 0 |
NCT06239272 | Phase Ib/II | Selinexor Pazopanib Doxorubicin + Ifosfamide | NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS) | Recruiting | USA | 0 |
NCT02091245 | Phase I | Selinexor | Phase I Trial of the Selective Inhibitor of Nuclear Export, KPT-330, in Relapsed Childhood ALL and AML | Active, not recruiting | USA | 0 |
NCT02419495 | Phase I | Cyclophosphamide Pemetrexed Disodium Eribulin Selinexor Carboplatin Paclitaxel Topotecan Dexamethasone Doxorubicin | Selinexor in Combination With Standard Chemotherapy | Terminated | USA | 0 |
NCT02088541 | Phase II | Cytarabine Azacitidine Decitabine Selinexor Hydroxyurea | Selinexor (KPT-330) in Older Patients With Relapsed AML | Completed | USA | POL | NLD | ITA | ISR | GBR | FRA | ESP | DNK | DEU | CAN | 0 |
NCT02485535 | Phase I | Selinexor | Selinexor in Treating Patients With Intermediate- and High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome After Transplant | Completed | USA | 0 |
NCT01607905 | Phase I | Selinexor | Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced or Metastatic Solid Tumor Cancer | Completed | USA | DNK | CAN | 0 |
NCT05985161 | Phase II | Selinexor | A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors | Recruiting | USA | 0 |
NCT02212561 | Phase Ib/II | Selinexor Cytarabine Cytarabine + Dexamethasone + Methotrexate Fludarabine | Selinexor With Fludarabine and Cytarabine for Treatment of Refractory or Relapsed Leukemia or Myelodysplastic Syndrome | Completed | USA | 0 |
NCT02606461 | Phase II | Selinexor | KCP-330-020 SEAL (Selinexor in Advanced Liposarcoma) (SEAL) | Completed | USA | SWE | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BEL | 0 |
NCT04595994 | Phase I | Selinexor | Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma and Osteosarcoma | Recruiting | ESP | 0 |
NCT05099003 | Phase Ib/II | Selinexor | A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG) | Recruiting | USA | NZL | CAN | AUS | 0 |
NCT02250885 | Phase II | Selinexor | KPT-330 to Treat Poorly Differentiated Lung and Gastroenteropancreatic Tumors | Completed | USA | 0 |
NCT03555422 | Phase III | Selinexor | Maintenance With Selinexor/Placebo After Combination Chemotherapy in Endometrial Cancer [SIENDO] (SIENDO) | Active, not recruiting | USA | ITA | ISR | GRC | ESP | DEU | CZE | CAN | BEL | 1 |
NCT02215161 | Phase II | Selinexor | Selinexor (KPT-330) in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Prior Therapy With Abiraterone and/or Enzalutamide | Terminated | USA | 0 |
NCT02403310 | Phase I | Cytarabine + Daunorubicin Selinexor | A Study of Selinexor in Combination With Daunorubicin and Cytarabine for Untreated AML | Completed | USA | 0 |
NCT02402764 | Phase II | Selinexor | Phase 2 Trial of Selinexor (KPT-330) for Metastatic TNBC | Completed | USA | 0 |
NCT05611931 | Phase III | Selinexor | Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma (XPORT-EC-042) | Recruiting | USA | SVK | ITA | ISR | IRL | HUN | GRC | ESP | DEU | CZE | CAN | BEL | AUS | 1 |
NCT01986348 | Phase II | Selinexor | Phase 2 Study of Selinexor (KPT-330) in Patients With Recurrent Glioblastoma After Failure of Radiation and Temozolomide | Terminated | USA | NLD | DNK | 0 |