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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

Selinexor and HAAG With/Without HMA in Relapsed/Refractory Acute Leukemia (AML) Patients

Not Applicable
Not yet recruiting
Conditions
Relapsed/Refractory AML
Interventions
First Posted Date
2023-04-07
Last Posted Date
2023-05-06
Lead Sponsor
The First Affiliated Hospital of Soochow University
Target Recruit Count
20
Registration Number
NCT05805072
Locations
🇨🇳

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

Selinexor Combined With R-GemOx as Second-line Treatment in Patients With Diffuse Large B-cell Lymphoma

Phase 4
Recruiting
Conditions
Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Interventions
First Posted Date
2023-03-28
Last Posted Date
2023-03-28
Lead Sponsor
Chongqing University Cancer Hospital
Target Recruit Count
32
Registration Number
NCT05786989
Locations
🇨🇳

Chongqing University Cancer Hospital, Chongqing, Chongqing, China

Adaptive Treatment for Acute Myeloid Leukemia Based on D14 MRD Results

Phase 2
Recruiting
Conditions
MRD
AML
Interventions
First Posted Date
2023-02-21
Last Posted Date
2023-03-15
Lead Sponsor
Shanghai Tong Ren Hospital
Target Recruit Count
58
Registration Number
NCT05736978
Locations
🇨🇳

Pla Navy Feature Medical Center, Shanghai, China

🇨🇳

Shanghai Ruijin Hospital, Shanghai, China

🇨🇳

Shanghai Tong Ren hospital, Shanghai, China

and more 1 locations

A Study of Selinexor in Combination With Azacitidine and Venetoclax (SAV Regimen) in Treatment Naïve Participants With Acute Myeloid Leukemia

Phase 2
Recruiting
Conditions
AML, Adult
Interventions
First Posted Date
2023-02-21
Last Posted Date
2023-03-15
Lead Sponsor
Shanghai Tong Ren Hospital
Target Recruit Count
58
Registration Number
NCT05736965
Locations
🇨🇳

Jilin University China Japan Union Hospital, Ch'ang-ch'un, China

🇨🇳

Changzhou Municipal No.1 People's Hospital, Changzhou, China

🇨🇳

Sichuan Provincial People's Hospital, Chengdu, China

and more 16 locations

Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia

Phase 3
Recruiting
Conditions
Relapsed or Refractory Acute Myeloid Leukemia
Interventions
First Posted Date
2023-02-13
Last Posted Date
2024-10-22
Lead Sponsor
Shanxi Bethune Hospital
Target Recruit Count
50
Registration Number
NCT05726110
Locations
🇨🇳

Tao Wang, Taiyuan, Shanxi, China

Selinexor in Combination With MTX+Ritu to Treat R/R CNSL

Phase 1
Recruiting
Conditions
Central Nervous System Lymphoma
Interventions
First Posted Date
2023-01-26
Last Posted Date
2024-06-17
Lead Sponsor
Tong Chen, MD
Target Recruit Count
30
Registration Number
NCT05698147
Locations
🇨🇳

Oncology Department of The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

🇨🇳

Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China

🇨🇳

The First Affiliated Hospital Of Fujian Medical University, Fuzhou, Fujian, China

and more 2 locations

Selinexor in Maintenance Therapy After Systemic Therapy for Participants With p53 Wild-Type, Advanced or Recurrent Endometrial Carcinoma

Phase 3
Recruiting
Conditions
Endometrial Cancer
Interventions
Drug: Matching Placebo for selinexor
First Posted Date
2022-11-10
Last Posted Date
2025-01-22
Lead Sponsor
Karyopharm Therapeutics Inc
Target Recruit Count
220
Registration Number
NCT05611931
Locations
🇺🇸

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

🇺🇸

Cancer and Blood Specialty Clinic, Los Alamitos, California, United States

🇺🇸

Jupiter Medical Center, Jupiter, Florida, United States

and more 204 locations

Selinexor for the Treatment of Intermediate and High-Risk Smoldering Multiple Myeloma

Phase 2
Recruiting
Conditions
Smoldering Multiple Myeloma
Interventions
First Posted Date
2022-10-28
Last Posted Date
2025-02-10
Lead Sponsor
University of Rochester
Target Recruit Count
15
Registration Number
NCT05597345
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients

Phase 1
Recruiting
Conditions
EBV-Positive Diffuse Large B-Cell Lymphoma, Nos
Interventions
Drug: R-CHOP Protocol
First Posted Date
2022-10-13
Last Posted Date
2023-12-14
Lead Sponsor
Sun Yat-sen University
Target Recruit Count
54
Registration Number
NCT05577364
Locations
🇨🇳

Sun Yat-sen Universitiy Cancer Center, Guangzhou, Guangdong, China

🇨🇳

Fudan University Shanghai Cancer Center, Shanghai, China

Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma

Phase 2
Recruiting
Conditions
Relapsed and Refractory Multiple Myeloma
Interventions
First Posted Date
2022-09-07
Last Posted Date
2025-02-17
Lead Sponsor
University of Miami
Target Recruit Count
33
Registration Number
NCT05530421
Locations
🇺🇸

University of Miami, Lennar Foundation Medical Center, Coral Gables, Florida, United States

🇺🇸

University of Miami, Sylvester Comprehensive Cancer Center, Miami, Florida, United States

🇺🇸

University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach, Deerfield Beach, Florida, United States

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