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

NCT02120222 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-13124NCI-2014-00676
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent Melanoma

Keywords

melanoma

Outcome Measures

Primary Outcomes (1)

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

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

  28 days

Secondary Outcomes (3)

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

  Up to 1 year

• PFS

  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

• Change in tumor markers by immunohistochemistry

  Baseline to up to 1 year

Study Arms (1)

Treatment (selinexor)

EXPERIMENTAL

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.

Drug: selinexor; Other: Correlative studies

Interventions

selinexor DRUG

Given PO

Also known as: CRM1 nuclear export inhibitor KPT-330, KPT-330, selective inhibitor of nuclear export KPT-330, SINE KPT-330

Treatment (selinexor)

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.

Also known as: pharmacological studies, pharmacokinetics, pharmacodynamics

Treatment (selinexor)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent in accordance with federal, local, and institutional guidelines
• Patients with unresectable melanoma
• Patients must have received a biologic therapy (e.g. interleukin 2) and a BRAF and/or MEK inhibitor (if tumor contains the V600E or V600K mutation) for 628 metastatic disease. If patient did not receive such agents, rationale for not treating the patients with the 629 agent must be cleared with the study PI (ie no V600e/k BRAF mutation or patient with autoimmunity, thus 630 not eligible for biologic therapy).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Total white blood cell (WBC) count \>= 3000/mm\^3
• Absolute neutrophil count (ANC) \>= 1500/mm\^3
• Platelet count \>= 100,000/mm\^3
• Bilirubin \< 2 times the upper limit of normal (ULN) (except patients with Gilbert's syndrome who must have a total bilirubin of \< 3 times ULN)
• Alanine aminotransferase (ALT) \< 2.5 times ULN; in the case of known (radiological and/or biopsy documented) liver metastasis, ALT \< 5.0 times ULN is acceptable
• Estimated creatinine clearance of \>= 50 mL/min, calculated using the formula of Cockroft and Gault
• Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose

You may not qualify if:

• Patients who are pregnant or lactating
• Radiation, chemotherapy, immunotherapy or any other systemic anticancer therapy =\< 2 weeks prior to initiation of therapy
• Major surgery within four weeks before initiation of therapy
• Unstable cardiovascular function:
• Symptomatic ischemia, or
• Uncontrolled clinically significant conduction abnormalities (e.g.: ventricular tachycardia on antiarrhythmics are excluded and 1st degree atrioventricular (AV) block or asymptomatic left anterior fascicular block \[LAFB\]/right bundle branch block \[RBBB\] will not be excluded)
• Congestive heart failure (CHF) of New York Heart Association (NYHA) class \>= 3, or
• Myocardial infarction (MI) within 3 months of initiation of therapy
• Uncontrolled active infection within one week prior to first dose
• Known to be human immunodeficiency virus (HIV) seropositive
• Known active hepatitis A, B, or C infection; or known to be positive for hepatitis C virus (HCV) ribonucleic acid (RNA) or HBsAg (hepatitis B virus \[HBV\] surface antigen)
• Patients with active central nervous system (CNS) malignancy
• Asymptomatic small lesions are not considered active
• Treated lesions may be considered inactive if the patient is able to taper off steriods without any recurrent neurologic symptoms.
• Patients will be excluded if they have had a major resection of the bowel that could influence absorption, inflammatory bowel disease, or other gastrointestinal conditions with increased risk of perforation, history of abdominal fistula, gastrointestinal perforation within 28 days prior to beginning study treatment

Sponsors & Collaborators

• Kari Kendra: lead
• Karyopharm Therapeutics Inc: collaborator

Study Sites (1)

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Melanoma

Interventions

selinexor; Pharmacokinetics

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Metabolism; Pharmacological and Toxicological Phenomena; Physiological Phenomena

Study Officials

• Kari Kendra

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: April 22, 2014
• Study Start: August 22, 2014
• Primary Completion: April 8, 2018
• Study Completion: April 8, 2018
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)