Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery (KPT-330)
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|ClinicalTrials.gov Identifier: NCT02120222|
Recruitment Status : Recruiting
First Posted : April 22, 2014
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Melanoma||Drug: selinexor Other: Correlative studies||Phase 1|
I. To estimate safety of KPT-330 (selinexor) in patients with melanoma at the maximum tolerated dose (MTD) defined by the phase 1 study.
I. To determine the clinical benefit rate (CBR) (complete response, partial response, and stable disease) of patients with unresectable melanoma.
II. To assess the efficacy at the MTD as measured by progression free survival (PFS) in patients with melanoma.
I. To validate nuclear transport inhibition resulting from treatment. II. To assess if v-raf murine sarcoma viral oncogene homolog B1 (BRAF), neuroblastoma RAS viral (v-ras) oncogene homolog (NRAS), or platelet-derived growth factor receptor, beta polypeptide (PDGFRB) mutational status impacts response.
III. To assess alteration in signaling pathways as a result of therapy with KPT-330.
IV. To assess immunologic changes resulting from treatment with KPT-330.
Patients receive selinexor orally (PO) twice weekly (BIW). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Expansion Cohort Evaluating the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients With Unresectable Melanoma|
|Actual Study Start Date :||May 27, 2014|
|Estimated Primary Completion Date :||July 31, 2018|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: Treatment (selinexor)
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.
Other: Correlative studies
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.
- Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: 28 days ]Types of toxicities, incidences and severity will be summarized by descriptive statistics such as frequencies/proportions.
- CBR (complete response, partial response, stable disease or stable disease) using Response Evaluation Criteria in Solid Tumors [ Time Frame: Up to 1 year ]
- PFS [ Time Frame: 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 ]Kaplan-Meier method will be used to assess the PFS.
- Change in tumor markers by immunohistochemistry [ Time Frame: Baseline to up to 1 year ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02120222
|Contact: The Ohio State University Comprehensive Cancer Center||1-800-293-5066||Jamesline@osumc.edu|
|Contact: Kari Kendra, MD||614-293-7956||Kari.Kendra@osumc.edu|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Kari L. Kendra, MD 614-293-9907 Kari.Kendra@osumc.edu|
|Contact: Lauren Kulesza 614-685-5028 email@example.com|
|Principal Investigator: Kari L. Kendra, MD|
|Principal Investigator:||Kari Kendra||Ohio State University Comprehensive Cancer Center|