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Last Updated: May 17, 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 Recruiting 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 Recruiting 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.
>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 Active, not recruiting Karyopharm Therapeutics, Inc Phase 1 2012-06-01 The purpose of this research study are to find out more information such as: the highest dose of KPT-330 that can be given safely, the side effects it may cause, to examine how the body affects the study drug concentrations in the blood (pharmacokinetics or PK), to examine the effects of this study drug on the body (pharmacodynamics or PDn) and to gain some information on its effectiveness in treating cancer.
NCT01607905 Safety Study of KPT-330 in Patients With Advanced or Metastatic Solid Tumor Cancer Active, not recruiting Karyopharm Therapeutics, Inc Phase 1 2012-06-01 Phase 1 study to evaluate the safety and tolerability of KPT-330 and determine the Recommended Phase 2 Dose (RP2D) of KPT- 330 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 Active, not recruiting 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 A Phase 2 Study Evaluating the Efficacy and Safety of Selinexor (KPT-330) in Patients With Recurrent Gliomas Recruiting Karyopharm Therapeutics, Inc Phase 2 2014-03-01 This is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral Selinexor in patients with recurrent gliomas.
NCT02025985 Phase II Study of KPT-330 (Selinexor) in Female Patients With Advanced Gynaecologic Malignancies & Metastatic Breast Cancer Active, not recruiting Karyopharm Therapeutics, Inc Phase 2 2014-01-01 The primary trial objective is to determine the efficacy of KPT-330 (selinexor) in patients with advanced or metastatic gynaecological cancers by disease control rate (complete response (CR) or partial response (PR) or stable disease (SD) for at least 12 weeks, assessed according to RECIST 1.1 criteria).
NCT02069730 A Study of Drug Therapies for Salivary Gland Cancers Based on Testing of Genes Recruiting University Health Network, Toronto N/A 2014-06-01 This is a study of select drug therapies in patients with salivary gland cancer. The study has two phases: a molecular profiling phase (phase 1) and a treatment phase (phase 2). In molecular profiling phase of the study, participants will provide a sample of their tumor tissue to test for changes in certain genes that show whether certain drug treatments will be more useful than others. Once participants have undergone molecular profiling, they will be offered a drug treatment depending on the results. Certain drug treatments are designed to target certain gene changes. If there is a matching drug treatment, participants will be offered that treatment (either outside a clinical trial or within a clinical trial). If there are no gene changes or there are changes to genes were there are no drug treatments available for those certain changes, participants will be offered the study drug, Selinexor. Cancer is the uncontrolled growth of cells. Research shows that one way cancer cells can grow uncontrollably is when certain proteins, called exporter proteins, are present in high levels in the body. These proteins prevent certain other proteins important in protecting cells from becoming cancerous and important in the controlling the growth of cells, from working. The study drug Selinexor is new class of drug called Selective Inhibitor of Nuclear Export (SINE) that blocks the exporter proteins from working which may allow the other proteins to work and slow or stop tumors from growing.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for SELINEXOR

Condition Name

Condition Name for SELINEXOR
Intervention Trials
Multiple Myeloma 12
Acute Myeloid Leukemia 8
Refractory Multiple Myeloma 4
Diffuse Large B-cell Lymphoma 4
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Condition MeSH

Condition MeSH for SELINEXOR
Intervention Trials
Neoplasms, Plasma Cell 20
Multiple Myeloma 20
Leukemia, Myeloid, Acute 15
Leukemia 13
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Clinical Trial Locations for SELINEXOR

Trials by Country

Trials by Country for SELINEXOR
Location Trials
United States 190
Canada 27
United Kingdom 12
Spain 11
Germany 8
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Trials by US State

Trials by US State for SELINEXOR
Location Trials
New York 19
Ohio 14
Texas 14
California 13
Florida 12
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Clinical Trial Progress for SELINEXOR

Clinical Trial Phase

Clinical Trial Phase for SELINEXOR
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 2
Phase 2 36
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Clinical Trial Status

Clinical Trial Status for SELINEXOR
Clinical Trial Phase Trials
Recruiting 43
Not yet recruiting 32
Active, not recruiting 9
[disabled in preview] 11
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Clinical Trial Sponsors for SELINEXOR

Sponsor Name

Sponsor Name for SELINEXOR
Sponsor Trials
Karyopharm Therapeutics, Inc 41
Karyopharm Therapeutics Inc 27
National Cancer Institute (NCI) 13
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Sponsor Type

Sponsor Type for SELINEXOR
Sponsor Trials
Industry 75
Other 69
NIH 13
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