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Last Updated: December 3, 2021

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CLINICAL TRIALS PROFILE FOR SELINEXOR

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505(b)(2) Clinical Trials for selinexor

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Combination NCT02137356 ↗ Selinexor Combined With Standard Chemoradiation as Neoadjuvant Treatment in Locally Advanced Rectal Cancer Unknown status Karyopharm Therapeutics Inc Phase 1 2014-12-01 Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This treatment is associated with only a 15-20% pathological complete response. Selinexor (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has demonstrated radiosensitization with in vivo models and has suggested single agent activity against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard chemoradiation combined with Selinexor. We hypothesize that tumors treated with this new combination will demonstrate an increased response rate compared to those treated with capecitabine-radiation alone.
New Combination NCT02137356 ↗ Selinexor Combined With Standard Chemoradiation as Neoadjuvant Treatment in Locally Advanced Rectal Cancer Unknown status Karyopharm Therapeutics, Inc Phase 1 2014-12-01 Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This treatment is associated with only a 15-20% pathological complete response. Selinexor (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has demonstrated radiosensitization with in vivo models and has suggested single agent activity against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard chemoradiation combined with Selinexor. We hypothesize that tumors treated with this new combination will demonstrate an increased response rate compared to those treated with capecitabine-radiation alone.
New Combination NCT02137356 ↗ Selinexor Combined With Standard Chemoradiation as Neoadjuvant Treatment in Locally Advanced Rectal Cancer Unknown status Sheba Medical Center Phase 1 2014-12-01 Locally advanced rectal cancer (T3, T4 or lymph node positive tumors) are conventionally treated with 5FU / capecitabine based chemoradiation prior to surgical resection. This treatment is associated with only a 15-20% pathological complete response. Selinexor (KPT-330) is a Selective Inhibitor of Nuclear Export (SINE) XPO1 antagonist that has demonstrated radiosensitization with in vivo models and has suggested single agent activity against colorectal cancers in a Phase I trial. Here we perform a Phase I/Ib trial of standard chemoradiation combined with Selinexor. We hypothesize that tumors treated with this new combination will demonstrate an increased response rate compared to those treated with capecitabine-radiation alone.
New Combination NCT02436707 ↗ Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Janssen, LP Phase 2 2015-05-05 The purpose of this study is to find out what effects new combinations of treatment will have this disease. New promising treatment strategies will be added to this study as they are available to be compared against the standard treatment.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for selinexor

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01607892 ↗ Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer Completed Karyopharm Therapeutics Inc Phase 1 2012-07-23 The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.
NCT01607892 ↗ Safety Study of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Advanced Hematological Cancer Completed Karyopharm Therapeutics, Inc Phase 1 2012-07-23 The purpose of this research study is to find out more information relating to the highest dose of KCP-330 that can be given safely and side effects it may cause, to examine how the body affects KCP-330 concentrations in the blood (pharmacokinetics or PK), to examine the effects of KCP-330 on the body (pharmacodynamics or PDn) and to obtain information on its effectiveness in treating cancer.
NCT01607905 ↗ Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer Completed Karyopharm Therapeutics Inc Phase 1 2012-06-18 Phase 1 study to evaluate the safety and tolerability of selinexor and determine the Recommended Phase 2 Dose (RP2D) of selinexor for advanced or metastatic solid tumor malignancies.
NCT01607905 ↗ Safety Study of KPT-330 (Selinexor) in Patients With Advanced or Metastatic Solid Tumor Cancer Completed Karyopharm Therapeutics, Inc Phase 1 2012-06-18 Phase 1 study to evaluate the safety and tolerability of selinexor and determine the Recommended Phase 2 Dose (RP2D) of selinexor for advanced or metastatic solid tumor malignancies.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for selinexor

Condition Name

Condition Name for selinexor
Intervention Trials
Multiple Myeloma 15
Acute Myeloid Leukemia 8
Diffuse Large B-Cell Lymphoma 4
Refractory Multiple Myeloma 4
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Condition MeSH

Condition MeSH for selinexor
Intervention Trials
Neoplasms, Plasma Cell 24
Multiple Myeloma 24
Leukemia, Myeloid, Acute 16
Leukemia 15
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Clinical Trial Locations for selinexor

Trials by Country

Trials by Country for selinexor
Location Trials
United States 340
Canada 41
China 33
India 22
Spain 21
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Trials by US State

Trials by US State for selinexor
Location Trials
New York 32
California 23
Texas 23
Ohio 21
Florida 19
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Clinical Trial Progress for selinexor

Clinical Trial Phase

Clinical Trial Phase for selinexor
Clinical Trial Phase Trials
Phase 3 4
Phase 2/Phase 3 2
Phase 2 40
[disabled in preview] 21
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Clinical Trial Status

Clinical Trial Status for selinexor
Clinical Trial Phase Trials
Recruiting 40
Completed 24
Active, not recruiting 12
[disabled in preview] 9
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Clinical Trial Sponsors for selinexor

Sponsor Name

Sponsor Name for selinexor
Sponsor Trials
Karyopharm Therapeutics Inc 75
Karyopharm Therapeutics, Inc 41
National Cancer Institute (NCI) 18
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Sponsor Type

Sponsor Type for selinexor
Sponsor Trials
Industry 126
Other 89
NIH 18
[disabled in preview] 1
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