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Report for Clinical Trial NCT02120222

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1 Expansion Cohort Evaluating the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Unresectable Melanoma

This phase I clinical trial studies the side effects of selinexor in treating patients with melanoma that cannot be removed by surgery. Drugs used in chemotherapy, such as selinexor, may stop the growth of tumor cells, by stopping them from dividing.

NCT02120222 Recurrent Melanoma
MeSH:Melanoma
HPO:Cutaneous melanoma Melanoma

2 Interventions

Name: selinexor

Description: Given PO
Type: Drug
Group Labels: 1

Treatment (selinexor)

Name: Correlative studies

Description: Blood will be collected for pK and pDn analysis pretreatment on day 1 and 8 hours after treatment, on day 1 of cycles 1 and 2.
Type: Other
Group Labels: 1

Treatment (selinexor)


Primary Outcomes

Description: Types of toxicities, incidences and severity will be summarized by descriptive statistics such as frequencies/proportions.

Measure: Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

Time: 28 days

Secondary Outcomes

Measure: CBR (complete response, partial response, stable disease or stable disease) using Response Evaluation Criteria in Solid Tumors

Time: Up to 1 year

Description: Kaplan-Meier method will be used to assess the PFS.

Measure: PFS

Time: From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause or last contact, assessed up to 1 year

Description: Markers with continuous numerical data will be analyzed using linear mixed effects models (LMEMs). Binary markers (presence vs. absence) will be summarized by proportions and the confidence intervals will be calculated. Marker changes by mutation groups in plots will be presented. To correlate the marker changes with response, mainly summary statistics and plots will be used given the potentially small subgroups.

Measure: Change in tumor markers by immunohistochemistry

Time: Baseline to up to 1 year

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 V600E

interleukin 2) and a BRAF and/or MEK inhibitor (if tumor contains the V600E or V600K mutation) for 628 metastatic disease. --- V600E ---


2 V600K

interleukin 2) and a BRAF and/or MEK inhibitor (if tumor contains the V600E or V600K mutation) for 628 metastatic disease. --- V600E --- --- V600K ---



HPO Nodes


HPO: