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Selective Inhibitor of Nuclear Export (SINE)

selinexor for Melanoma (KPT-330 Trial)

Phase 1
Waitlist Available
Research Sponsored by Kari Kendra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights

KPT-330 Trial Summary

This trial is studying the side effects of selinexor in treating patients with melanoma that has spread and cannot be removed by surgery.

Eligible Conditions
  • Melanoma

KPT-330 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03
Secondary outcome measures
CBR (complete response, partial response, stable disease or stable disease) using Response Evaluation Criteria in Solid Tumors
Change in tumor markers by immunohistochemistry
PFS

KPT-330 Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (selinexor)Experimental Treatment2 Interventions
Patients receive selinexor PO BIW. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Blood will be collected for correlative studies to perform pK (pharmacokinetics) and pDn (pharmacodynamics) analysis pretreatment on day 1 and 8 hours after treatment, on day 1 of cycles 1 and 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selinexor
FDA approved

Find a Location

Who is running the clinical trial?

Kari KendraLead Sponsor
2 Previous Clinical Trials
40 Total Patients Enrolled
1 Trials studying Melanoma
30 Patients Enrolled for Melanoma
Karyopharm Therapeutics IncIndustry Sponsor
87 Previous Clinical Trials
7,571 Total Patients Enrolled
1 Trials studying Melanoma
40 Patients Enrolled for Melanoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any capacity for additional participants in this research?

"Unfortunately, this research has closed to further recruitment. Initially posted on August 22nd 2014 and last modified on September 5th 2022; for those looking for alternative trials, there are currently 753 clinical studies accepting patients with recurrent melanoma or 48 studies using selinexor as an intervention actively enrolling participants."

Answered by AI

Is this study the pioneer of its kind?

"Selinexor has been under scientific investigation since 2014, when Karyopharm Therapeutics Inc. launched their initial research into the drug's efficacy and safety. This Phase 1 trial involved 16 patients and selinexor received approval following its completion. As of today, 48 clinical studies are currently in progress across 28 different nations with 259 cities represented."

Answered by AI

Have there been other analyses conducted with regard to selinexor?

"Currently, 48 trials are researching the efficacy of selinexor with 4 studies in Phase 3. While a handful of these experiments take place near Bethesda, MD., there are 922 locations across the globe running clinical trials for this drug."

Answered by AI

What is the recruitment rate for this clinical trial?

"Unfortunately, enrolment for this trial is no longer possible. It was first published on August 22nd 2014 and last updated September 5th 2022. If you are seeking other studies, 753 trials with recurrent melanoma as the focus are in need of patients, while 48 clinical trials require participants to test selinexor's efficacy."

Answered by AI

To what extent could selinexor be hazardous to patients?

"Due to the relative scarcity of evidence supporting safety and efficacy, selinexor received a score of 1 on our team's risk assessment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery
Kari Kendra 2014. "Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02120222.
~1 spots leftby Apr 2025
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