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Recurrent MelanomaPhase 1KPT-330NCT02120222

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

A Phase 1 study testing selinexor and Correlative studies in people with Recurrent Melanoma, run by Kari Kendra at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Melanoma
What is being tested?
selinexor and Correlative studies
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
22 Aug 2014to 8 Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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
  • Grade >= 2 peripheral neuropathy within 14 days prior to initiation of therapy
  • History of seizures, movement disorders or cerebrovascular accident within the past 5 years
  • Patients with known macular degeneration or uncontrolled glaucoma
  • In the opinion of the investigator, patients who are significantly below their ideal body weight
  • Serious psychiatric or medical conditions that could interfere with treatment
  • Participation in an investigational anti-cancer study within 3 weeks prior to initiation of therapy
  • Concurrent therapy with approved or investigational anticancer therapeutic

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To estimate safety of KPT-330 (selinexor) in patients with melanoma at the maximum tolerated dose (MTD) defined by the phase 1 study.

SECONDARY OBJECTIVES:

  1. 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.

TERTIARY OBJECTIVES:

  1. 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.

OUTLINE:

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

Being tested
selinexor, Correlative studies
Keywords
melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • selinexorDrug

    Also called CRM1 nuclear export inhibitor KPT-330, KPT-330, selective inhibitor of nuclear export KPT-330, SINE KPT-330

    Given PO

  • Correlative studiesOther

    Also called pharmacological studies, pharmacokinetics, pharmacodynamics

    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 groups in NCT02120222
Study groupRoleWhat they receive
Treatment (selinexor)ExperimentalPatients 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.
Receives: Drug: selinexor; Other: Correlative studies

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28 days

Secondary outcomes (3)

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

    Measured: Up to 1 year

  2. PFS

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

    Measured: 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

  3. Change in tumor markers by immunohistochemistry

    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.

    Measured: Baseline to up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2014 (estimated)
  2. Study start22 Aug 2014
  3. Primary completion8 Apr 2018
  4. Study completion8 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02120222
Sponsor's protocol ID
OSU-13124
Other IDs
NCI-2014-00676
Acronym
KPT-330
Status last verified
Mar 2023
First submitted
17 Apr 2014
Last updated
4 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing selinexor and Correlative studies in people with Recurrent Melanoma, run by Kari Kendra at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02120222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.

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