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Last Updated: April 25, 2024

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.
New Combination NCT02436707 ↗ Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Karyopharm Therapeutics Inc 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.
New Combination NCT02436707 ↗ Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Roche Pharma AG 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.
New Combination NCT02436707 ↗ Novel Combination Therapy in the Treatment of Relapsed and Refractory Aggressive B-Cell Lymphoma Recruiting Canadian Cancer Trials Group 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.
NCT01896505 ↗ A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma Completed Karyopharm Therapeutics Inc Phase 1 2013-07-01 The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets, to compare PK of capsules and tablets, to assess the effects of KPT-330 on cellular morphology and biomarker changes on sarcoma biopsy specimens (in patients who can safely undergo biopsy).
NCT01896505 ↗ A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma Completed Karyopharm Therapeutics, Inc Phase 1 2013-07-01 The purpose of this research study is to find out more information such as: to determine the effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets, to compare PK of capsules and tablets, to assess the effects of KPT-330 on cellular morphology and biomarker changes on sarcoma biopsy specimens (in patients who can safely undergo biopsy).
NCT01986348 ↗ Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Participants With Recurrent Gliomas Terminated Karyopharm Therapeutics Inc Phase 2 2014-03-03 This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in participants with recurrent gliomas.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Selinexor

Condition Name

Condition Name for Selinexor
Intervention Trials
Multiple Myeloma 19
Acute Myeloid Leukemia 8
Refractory Multiple Myeloma 5
Diffuse Large B-Cell Lymphoma 5
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Condition MeSH

Condition MeSH for Selinexor
Intervention Trials
Neoplasms, Plasma Cell 34
Multiple Myeloma 34
Leukemia, Myeloid, Acute 19
Lymphoma 19
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Clinical Trial Locations for Selinexor

Trials by Country

Trials by Country for Selinexor
Location Trials
United States 345
China 58
Canada 41
India 22
Spain 21
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Trials by US State

Trials by US State for Selinexor
Location Trials
New York 33
California 23
Texas 23
Ohio 21
Florida 20
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Clinical Trial Progress for Selinexor

Clinical Trial Phase

Clinical Trial Phase for Selinexor
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Selinexor
Clinical Trial Phase Trials
Recruiting 48
Not yet recruiting 25
Completed 24
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Clinical Trial Sponsors for Selinexor

Sponsor Name

Sponsor Name for Selinexor
Sponsor Trials
Karyopharm Therapeutics Inc 81
Karyopharm Therapeutics, Inc 41
National Cancer Institute (NCI) 20
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Sponsor Type

Sponsor Type for Selinexor
Sponsor Trials
Industry 139
Other 122
NIH 20
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