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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

Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment

Phase 1
Recruiting
Conditions
MGMT-Methylated Glioblastoma
Recurrent Glioblastoma, IDH-Wildtype
Recurrent MGMT-Methylated Glioblastoma
Interventions
Procedure: Biospecimen Collection
Procedure: Magnetic Resonance Imaging
First Posted Date
2022-06-27
Last Posted Date
2025-05-07
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
97
Registration Number
NCT05432804
Locations
🇺🇸

Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

🇺🇸

City of Hope Comprehensive Cancer Center, Duarte, California, United States

🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

and more 33 locations

Selinexor Plus R-CHOP in High-risk GCB-subtype Diffuse Large B-Cell Lymphoma

Phase 2
Recruiting
Conditions
DLBCL Germinal Center B-Cell Type
Interventions
First Posted Date
2022-06-16
Last Posted Date
2024-06-17
Lead Sponsor
Li Zhiming
Target Recruit Count
50
Registration Number
NCT05422066
Locations
🇨🇳

Henan Cancer Hospital, Zhengzhou, Henan, China

🇨🇳

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China

🇨🇳

Hubei Cancer Hospital, Wuhan, Hubei, China

and more 3 locations

Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma

Phase 1
Recruiting
Conditions
Multiple Myeloma
Interventions
First Posted Date
2022-06-16
Last Posted Date
2024-06-17
Lead Sponsor
Xia Zhongjun
Target Recruit Count
42
Registration Number
NCT05422027
Locations
🇨🇳

Sun Yat-sen University Cancer Center; State Key Laboratory of Oncology in South China,, Guangzhou, Guangdong, China

🇨🇳

Guangdong Provincial Peoples Hospital, Guangzhou, Guangdong, China

🇨🇳

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

and more 1 locations

Testing Atezolizumab With Selinexor in People ≥ 12 Years Old With Alveolar Soft Part Sarcoma, The AXIOM Trial

Phase 2
Recruiting
Conditions
Advanced Alveolar Soft Part Sarcoma
Advanced Soft Tissue Sarcoma
Metastatic Alveolar Soft Part Sarcoma
Refractory Alveolar Soft Part Sarcoma
Unresectable Alveolar Soft Part Sarcoma
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Echocardiography Test
First Posted Date
2022-04-19
Last Posted Date
2025-04-30
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
27
Registration Number
NCT05333458
Locations
🇺🇸

Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States

🇺🇸

Yale University, New Haven, Connecticut, United States

🇺🇸

Keck Medicine of USC Koreatown, Los Angeles, California, United States

and more 8 locations

Clinical Study of XPO-1 Inhibitors Plus CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma

Phase 2
Conditions
Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma
Interventions
Drug: Flu
Drug: CAR-T
First Posted Date
2022-04-11
Last Posted Date
2023-02-09
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
20
Registration Number
NCT05322330
Locations
🇨🇳

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

A Study of ATG-010 in Combination With Lenalidomide and Rituximab (R2) in Adults With DLBCL and iNHL

Phase 1
Recruiting
Conditions
Diffuse Large B-cell Lymphoma
Indolent Non-Hodgkin Lymphoma
Interventions
First Posted Date
2022-03-04
Last Posted Date
2024-04-09
Lead Sponsor
Antengene Corporation
Target Recruit Count
84
Registration Number
NCT05265975
Locations
🇨🇳

The Second Affiliated Hospital of PLA Army Medical University, Chongqing, Chongqing, China

🇨🇳

Wuhan Union Hospital, Wuhan, Hubei, China

🇨🇳

The first Affiliated Hospital of China medical University, Shenyang, Liaoning, China

and more 3 locations

A Study of a Fully Human BCMA-targeting CAR (CT103A) Combined With Selinexor in Patients With Relapsed/Refractory Extramedullary Multiple Myeloma

Phase 1
Conditions
Extramedullary Multiple Myeloma
Interventions
First Posted Date
2022-01-21
Last Posted Date
2022-05-24
Lead Sponsor
Chunrui Li
Target Recruit Count
20
Registration Number
NCT05201118
Locations
🇨🇳

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hu Bei, China

Selinexor Combination Ph 1 Study

Phase 1
Withdrawn
Conditions
Solid Tumor Malignancy
Interventions
First Posted Date
2022-01-04
Last Posted Date
2022-01-04
Lead Sponsor
Martin Gutierrez
Registration Number
NCT05177276
Locations
🇺🇸

John Theurer Cancer Center at HackensackUMC, Hackensack, New Jersey, United States

A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)

Phase 1
Suspended
Conditions
Anaplastic Astrocytoma
Diffuse Midline Glioma, H3 K27M-Mutant
Diffuse Intrinsic Pontine Glioma
Anaplastic Astrocytoma, Not Otherwise Specified
Glioblastoma, Not Otherwise Specified
Malignant Glioma
Glioblastoma
Interventions
Procedure: Biopsy Procedure
Procedure: Magnetic Resonance Imaging
Radiation: Radiation Therapy
First Posted Date
2021-10-29
Last Posted Date
2025-05-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
210
Registration Number
NCT05099003
Locations
🇺🇸

Children's Hospital of Alabama, Birmingham, Alabama, United States

🇺🇸

Banner Children's at Desert, Mesa, Arizona, United States

🇺🇸

Phoenix Childrens Hospital, Phoenix, Arizona, United States

and more 120 locations

SELINEXOR in Combination w/Bevacizumab and Atezolizumab in Newly Diagnosed Advanced Hepatocellular Carcinoma

Phase 1
Terminated
Conditions
Hepatocellular Carcinoma
Interventions
First Posted Date
2021-10-26
Last Posted Date
2022-10-17
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
2
Registration Number
NCT05093608
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

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