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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

Decitabine and Selinexor in Combination to Reverse Drug Resistance With Standard Chemotherapy in Ovarian Cancer

Phase 2
Recruiting
Conditions
Ovarian Cancer
Interventions
First Posted Date
2023-08-09
Last Posted Date
2024-02-08
Lead Sponsor
Loyola University
Target Recruit Count
40
Registration Number
NCT05983276
Locations
🇺🇸

Loyola University Medical Center, Maywood, Illinois, United States

A Study of Selinexor Monotherapy in Subjects With JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Phase 2
Recruiting
Conditions
Moderate Thrombocytopenia
Myelofibrosis
Interventions
First Posted Date
2023-08-08
Last Posted Date
2025-02-05
Lead Sponsor
Karyopharm Therapeutics Inc
Target Recruit Count
118
Registration Number
NCT05980806
Locations
🇧🇬

University Multiprofile Hospital for Active Treatment Sveti George - Base 1, Plovdiv, Bulgaria

🇧🇬

University Hospital Sv.Ivan Rilski - Sofia, Sofia, Bulgaria

🇫🇷

CHU Tours, Hôpital Bretonneau Service d'Hématologie thérapie cellulaire, Tours Cedex 01, Indre-et-Loire, France

and more 45 locations

Selinexor (Nexpovio®) (SVd) in Patients With Relapsed or Refractory Multiple Myeloma

Recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2023-07-20
Last Posted Date
2024-10-17
Lead Sponsor
iOMEDICO AG
Target Recruit Count
100
Registration Number
NCT05954780
Locations
🇩🇪

Gemeinschaftspraxis für Hämatologie und Onkologie GbR, Ravensburg, Baden-Württemberg, Germany

🇦🇹

Medizinische Universität Wien, Universitätsklinik für Innere Medizin I, Wien, Austria

Study of Selinexor Combined With Chidamide in Relapsed/Refractory Acute Leukemia (AML) Patients

Phase 2
Recruiting
Conditions
Acute Myeloid Leukemia (Relapsed/Refractory)
Interventions
First Posted Date
2023-07-19
Last Posted Date
2023-07-19
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
42
Registration Number
NCT05951855
Locations
🇨🇳

The First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China

Trial of Idasanutlin and Selinexor Therapy for Children With Progressive/Relapsed AT/RT or Extra-CNS Malignant Rhabdoid Tumors

Phase 1
Withdrawn
Conditions
Rhabdoid Tumor
Atypical Teratoid/Rhabdoid Tumor
CNS Tumor
Atypical Teratoid/Rhabdoid Tumor of CNS
Interventions
First Posted Date
2023-07-19
Last Posted Date
2024-03-27
Lead Sponsor
St. Jude Children's Research Hospital
Registration Number
NCT05952687

Mechanism Investigation of Selinexor Combined With Lenalidomide and Rituximab in the Treatment of Diffuse Large B-cell Lymphoma

Not yet recruiting
Conditions
Lymphoma, Large B-Cell, Diffuse
First Posted Date
2023-06-28
Last Posted Date
2023-06-28
Lead Sponsor
Ruijin Hospital
Target Recruit Count
30
Registration Number
NCT05923879
Locations
🇨🇳

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

SVRd for the Treatment of Newly Diagnosed Multiple Myeloma Patients Presenting With Extramedullary Disease

Phase 2
Recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2023-06-13
Last Posted Date
2023-08-14
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
35
Registration Number
NCT05900882
Locations
🇨🇳

Nanjing First People's Hospital, Nanjing, Jiangsu, China

🇨🇳

The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

🇨🇳

Taizhou People's Hospital, Taizhou, Jiangsu, China

and more 3 locations

A Real-world Study of Selinexor-based Regimens for Treatment of Non-Hodgkin Lymphoma

Recruiting
Conditions
Lymphoma
DLBCL
T Cell Lymphoma
Interventions
First Posted Date
2023-05-10
Last Posted Date
2023-05-10
Lead Sponsor
Ruijin Hospital
Target Recruit Count
250
Registration Number
NCT05852028
Locations
🇨🇳

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China

🇨🇳

The First Affiliated Hospital of Soochow University, Suzhou, China

🇨🇳

Union Hospital Affiliated to Huazhong University of Science and Technology, Wuhan, China

An Open, Single Center, Non-randomized, Single Arm Clinical Study of Evaluating the Efficacy of Selinexor in the Maintenance Treatment of PTCL

Phase 2
Recruiting
Conditions
PTCL Patients Who Achieved Complete Response From Frontline Treatment
Interventions
First Posted Date
2023-04-20
Last Posted Date
2023-08-03
Lead Sponsor
The First Hospital of Jilin University
Target Recruit Count
20
Registration Number
NCT05822050
Locations
🇨🇳

The First Bethune Hospital of Jilin University, Changchun, Jilin, China

Selinexor and Lenalidomide for Consolidation and Maintenance Treatment in Multiple Myeloma Post-transplant

Phase 2
Withdrawn
Conditions
Multiple Myeloma
Myeloma-Associated Amyloidosis
Interventions
First Posted Date
2023-04-20
Last Posted Date
2024-07-10
Lead Sponsor
Washington University School of Medicine
Registration Number
NCT05820763
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