Evaluating SINE KPT-330 in Treating Patients With Melanoma That Cannot Be Removed By Surgery

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Kari Kendra
Study ID
NCT02120222
Phase
PHASE1
Status
Completed

Conditions

  • Recurrent Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • selinexor — DRUG
    Given PO
  • Correlative studies — OTHER
    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.

Study Details

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.

Key Dates

Start date
Aug 22, 2014
Status verified
Mar 2023
Primary completion
Apr 8, 2018
Completion
Apr 8, 2018

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Incidence of adverse events graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 [ Time Frame: 28 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbusOhio43210-

Find similar trials in Columbus, OH

By research site
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center· Columbus, OH

Related Studies