MedPath

Selinexor

Generic Name
Selinexor
Brand Names
Xpovio 100 Mg Once Weekly Carton, Nexpovio
Drug Type
Small Molecule
Chemical Formula
C17H11F6N7O
CAS Number
1393477-72-9
Unique Ingredient Identifier
31TZ62FO8F
Background

Selinexor is a first-in-class selective inhibitor of nuclear transport (SINE) compound. Selinexor, in combination with bortezomib and dexamethasone, is currently approved for the treatment of multiple myeloma, a type of cancer formed from antibody-producing plasma cells. This condition is typically treated with high dose bortezomib and dexamethasone chemotherapy followed by an autologous stem-cell transplant. Other chemotherapies for multiple myeloma include lenalidomide and dexamethasone, thalidomide, and may include melphalan if the patient is not eligible for transplant. Selinexor was also granted accelerated approval for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that have gone through at least 2 lines of systemic therapy.

The FDA approved Selinexor in June 2019. The use of selinexor in combination with bortezomib and dexamethasone was approved by Health Canada in June 2022 for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

Indication

Selinexor is indicated in combination with bortezomib and dexamethasone for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. Selinexor is also indicated in combination with dexamethasone for the treatment of relapsed or refractory multiple myeloma in adult patients who have received at least four prior therapies and who are refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody.

Selinexor is also indicated under an accelerated approval scheme for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including that arising from follicular lymphoma, in adult patients who have received at least two prior lines of systemic therapy. Continued approval for this indication may be contingent on verification in confirmatory clinical trials.

Associated Conditions
Multiple Myeloma (MM), Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified, Refractory Multiple Myeloma, Relapsed Multiple Myeloma, Relapsed Diffuse large B-cell lymphoma NOS

Selinexor in Combination With R-CHOP as the First-line Therapy for TP53-mutated DLBCL Patients (Smart Trial)

Phase 2
Recruiting
Conditions
Diffuse Large B Cell Lymphoma
Interventions
First Posted Date
2024-07-24
Last Posted Date
2024-07-24
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
42
Registration Number
NCT06517511
Locations
🇨🇳

Sun yat-sen university cancer center, Guangzhou, Guangdong, China

🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, Shanghai, China

Telehealth-based Symptom Management for Veterans Treated With Selinexor

Active, not recruiting
Conditions
Large-cell Lymphoma
Multiple Myeloma
First Posted Date
2024-06-11
Last Posted Date
2025-02-10
Lead Sponsor
Durham VA Medical Center
Target Recruit Count
20
Registration Number
NCT06452446
Locations
🇺🇸

Durham VA Medical Center, Durham, North Carolina, United States

Selinexor、Venetoclax and Azactidine in the Treatment of ND AML Patients Who Are Not Eligible for Intense Chemotherapy

Phase 1
Recruiting
Conditions
Acute Myeloid Leukemia, Adult
Interventions
First Posted Date
2024-06-10
Last Posted Date
2024-06-10
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Target Recruit Count
20
Registration Number
NCT06449482
Locations
🇨🇳

Institute of Hematology & Blood Diseases Hospital, Tianjin, Tianjin, China

NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)

Phase 1
Recruiting
Conditions
Atypical Fibroxanthoma
Myoepithelioma
Fibrosarcoma NOS
Myxofibrosarcoma
Osteosarcoma, Extraskeletal
Adipocytic Neoplasm
Liposarcoma
Angiomatoid Fibrous Histiocytoma
Angiosarcoma
Interventions
Procedure: Surgical resection
Radiation: Proton beam radiation therapy
First Posted Date
2024-02-02
Last Posted Date
2025-04-25
Lead Sponsor
St. Jude Children's Research Hospital
Target Recruit Count
139
Registration Number
NCT06239272
Locations
🇺🇸

Washington University Medical Center, Saint Louis, Missouri, United States

🇺🇸

Our Lady of the Lake Children's Hospital, Baton Rouge, Louisiana, United States

🇺🇸

Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States

and more 1 locations

A Trial of Selinexor, Ruxolitinib and Methylprednisolone

Phase 1
Recruiting
Conditions
Multiple Myeloma in Relapse
Multiple Myeloma, Refractory
Interventions
First Posted Date
2024-01-25
Last Posted Date
2025-01-16
Lead Sponsor
Oncotherapeutics
Target Recruit Count
30
Registration Number
NCT06225310
Locations
🇺🇸

Berenson Cancer Center, West Hollywood, California, United States

Selinexor, Cyclophosphamide and Prednisone in Myeloma

Phase 2
Completed
Conditions
Relapsed or Refractory Multiple Myeloma
Interventions
First Posted Date
2024-01-19
Last Posted Date
2024-01-19
Lead Sponsor
University of Leeds
Target Recruit Count
66
Registration Number
NCT06212596
Locations
🇬🇧

Guys and St Thomas NHS Foundation Trust, London, United Kingdom

🇬🇧

Imperial College Healthcare NHS Trust, London, United Kingdom

🇬🇧

Royal Bournemouth Hospital, Bournemouth, United Kingdom

and more 10 locations

Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma

Phase 2
Recruiting
Conditions
Multiple Myeloma
Interventions
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
First Posted Date
2023-12-13
Last Posted Date
2025-03-14
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
70
Registration Number
NCT06169215
Locations
🇺🇸

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States

🇺🇸

UCI Health Laguna Hills, Laguna Hills, California, United States

🇺🇸

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

and more 24 locations

Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma

First Posted Date
2023-12-06
Last Posted Date
2025-05-15
Lead Sponsor
AbbVie
Target Recruit Count
380
Registration Number
NCT06158841
Locations
🇺🇸

University of Alabama at Birmingham - Main /ID# 261434, Birmingham, Alabama, United States

🇺🇸

Mayo Clinic Hospital - Phoenix /ID# 263326, Phoenix, Arizona, United States

🇺🇸

Alta Bates Summit Medical Center for Research /ID# 261438, Berkeley, California, United States

and more 139 locations

Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)

Phase 2
Recruiting
Conditions
Sarcoma,Soft Tissue
Interventions
First Posted Date
2023-11-02
Last Posted Date
2023-11-02
Lead Sponsor
Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas
Target Recruit Count
88
Registration Number
NCT06114004
Locations
🇪🇸

Hospital Universitario de Canarias, Tenerife, Canarias, Spain

🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

🇪🇸

Hospital Universitario Vall d'Hebron, Barcelona, Spain

and more 8 locations

A Study of Selinexor in People With Wilms Tumors and Other Solid Tumors

Phase 2
Recruiting
Conditions
Wilms Tumor
Malignant Peripheral Nerve Sheath Tumors
Rhabdoid Tumor
XPO1 Gene Mutation
Solid Tumor
MPNST
Nephroblastoma
Interventions
First Posted Date
2023-08-14
Last Posted Date
2025-05-01
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Target Recruit Count
36
Registration Number
NCT05985161
Locations
🇺🇸

Children's Hospital of Los Angeles (Data Collection Only), Los Angeles, California, United States

🇺🇸

Standford Medicine Children's Health, Palo Alto, California, United States

🇺🇸

Children's National Hospital, Washington, District of Columbia, United States

and more 12 locations
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