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Recurrent Small Cell Lung CarcinomaPhase 2NCT02351505

Selinexor in Treating Patients With Relapsed Small Cell Lung Cancer

A Phase 2 study testing Selinexor, Laboratory Biomarker Analysis and Pharmacological Study in people with Recurrent Small Cell Lung Carcinoma, run by Erin Bertino at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase II trial studies how well selinexor work in treating patients with small-cell lung cancer that has returned after a period of improvement. One specific way cancer cells continue to grow is by getting rid of certain proteins called "tumor suppressor proteins: that would normally cause cancer cells to die. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Small Cell Lung Carcinoma
What is being tested?
Selinexor, Laboratory Biomarker Analysis and Pharmacological Study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteUnited States
Study dates
May 2015to Mar 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 should have estimated life expectancy of > 3 months at study entry
  • Patients with relapsed small cell lung cancer - diagnosis must be histologically confirmed
  • Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at the time of study entry
  • Objective evidence of disease progression on study entry
  • Prior systemic anticancer therapy: patients will have received no more than 2 prior chemotherapy regimens; the regimen(s) may have included biological, molecularly targeted or immune therapies; patients with primary refractory disease (i.e., those patients with progressive disease on first line chemotherapy) and patients with disease relapse within 90 days of completion of initial chemotherapy (chemotherapy resistant) are excluded; patients with limited stage small cell lung cancer (SCLC) and systemic relapse who are not felt to be candidates for repeat platinum-based chemotherapy at relapse are eligible for enrollment
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • Absolute neutrophil count (ANC) > 1000/mm^3
  • Platelet count > 75,000 mm^3
  • Total 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
  • Albumin >= 3.0 mg/dl
  • Estimated creatinine clearance of >= 30 mL/min, calculated using the formula of Cockroft and Gault
  • Amylase =< 1.5 x ULN
  • Lipase =< 1.5 x ULN
  • Alkaline phosphatase limit =< 2.5 x ULN
  • Female patients of childbearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening; 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
  • Resolution to grade =< 1 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.03) of all clinically significant toxic effects of prior anti-cancer therapy (with the exception neuropathy, which may be =< grade 2 within 14 days prior to cycle 1 day 1)
  • Available archival tumor tissue or willingness to undergo repeat biopsy is required at trial initiation

Who cannot join

  • Primary refractory disease (progressive disease on initial platinum based chemotherapy) or chemotherapy-resistant disease (disease progression within 90 days of completion of initial chemotherapy)
  • Patients who are pregnant or lactating
  • Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks prior to cycle 1 day 1; any clinical trial therapy (including investigational anti-cancer study) =< 3 weeks prior to cycle 1 day 1
  • Prior treatment with selinexor
  • Major surgery within 3 weeks before day 1
  • Unstable cardiovascular function:
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  • Electrocardiogram (ECG) abnormalities requiring treatment, or
  • Congestive heart failure (CHF) of New York Heart Association (NYHA) class >= 3
  • Myocardial infarction (MI) within 3 months
  • Symptomatic ischemia or angina
  • Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study
  • 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) RNA or hepatitis B surface antigen (HBsAg) (hepatitis B virus [HBV] surface antigen)
  • Serious psychiatric or medical conditions that could interfere with treatment
  • History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
  • Concurrent therapy with approved or investigational anticancer therapeutic other than steroids
  • Patients with > 3 liver metastases at time of enrollment
  • Patients with coagulation problems and active bleeding in the last month (peptic ulcer, epistaxis, spontaneous bleeding)
  • Patients with significantly diseased or obstructed gastrointestinal tract, malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral medications
  • Patients who are severely underweight (body mass index [BMI] less than 17) or patients with a body surface area (BSA) < 1.4 m^2 as calculated per Dubois 1916 or Mosteller 1987
  • Uncontrolled brain metastases or leptomeningeal involvement; patients with brain metastases are permitted if they have received appropriate therapy and demonstrated control of the brain metastases or leptomeningeal disease following therapy; patients with known brain metastases will require magnetic resonance imaging (MRI) brain to demonstrate disease control prior to enrollment (lack of symptom progression for two weeks off therapeutic doses of steroids, excluding chronic steroids used for control of chronic obstructive pulmonary disease [COPD])
  • Prior cancer diagnosis is allowed if patient is disease-free for >= 3 years, or disease free for < 3 years for treated basal cell/ squamous cell skin cancer or in situ cervical cancer

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: An Investigator-Sponsored Phase 2 Study of Single Agent Selinexor (KPT-330) in Patients With Relapsed Small Cell Lung Cancer

This phase II trial studies how well selinexor work in treating patients with small-cell lung cancer that has returned after a period of improvement. One specific way cancer cells continue to grow is by getting rid of certain proteins called "tumor suppressor proteins: that would normally cause cancer cells to die. Selinexor works by trapping "tumor suppressing proteins" within the cell and may cause the cancer cells to die or stop growing.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To evaluate the efficacy of single agent selinexor as measured by progression free survival (PFS) in patients with relapsed chemotherapy-sensitive small cell lung cancer.

SECONDARY OBJECTIVES:

  1. To evaluate the objective tumor response rate and disease control rate as determined by radiographic response.

II. To evaluate the overall survival (OS) in patients with relapsed small cell lung cancer.

III. To evaluate safety and tolerability of single agent selinexor in these patient populations.

IV. Comparison between each patient's time to progression (TTP) on selinexor with the TTP of his/her previous therapy(ies).

  1. To evaluate correlative endpoints including tumor biopsy and analysis of secreted factors, leukocyte ribonucleic acid (RNA) analysis.

TERTIARY OBJECTIVES:

  1. Analysis of secreted factors (nerve growth factor [NGF], brain-derived neurotrophic factor [BDNF]).

II. Tumor biopsy (baseline and cycle 2).

OUTLINE:

Patients receive selinexor orally (PO) twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up monthly for 3 months, every 3 months for 1 year, and then every 6 months thereafter.

Being tested
Selinexor, Laboratory Biomarker Analysis, Pharmacological Study
Keywords
Small Cell Lung Cancer
Medical subject headings
Small Cell Lung Carcinoma

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pharmacological StudyOther

    Also called pharmacological studies

    Correlative studies

Study groups in NCT02351505
Study groupRoleWhat they receive
Treatment (selinexor)ExperimentalPatients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Selinexor; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

What is being measured

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

  1. Progression Free Survival

    Estimated by the method of Kaplan and Meier for each cohort. Appropriate one-sided 90% confidence boundary will also be calculated for the final test Kaplan-Meyer test statistic at 12 weeks.

    Measured: Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 years

Secondary outcomes (7)

  1. Objective Response Rate (Complete Response [CR] or Partial Response [PR]) by RECIST

    The overall response rate will be calculated as the number of PRs and CRs divided by the total number of evaluable patients. Estimates will be accompanied by exact binomial confidence intervals as well.

    Measured: Up to 4 years

  2. Disease Control Rate (CR, PR, and Stable Disease)

    Estimates will be accompanied by exact binomial confidence intervals.

    Measured: Up to 4 years

  3. Overall Survival

    Kaplan-Meier curves will be used to estimate overall survival. Consider Cox proportional hazards models to explore a limited set of confounding factors.

    Measured: Date of study registration to the date of event (i.e., death) or the date of last follow-up if no event has occurred at their last evaluation assessed up to 4 years

  4. Frequency of Adverse Events Defined as Adverse Events That Are Classified as Either Not Related, Possibly, Probably, or Definitely Related to Study Treatment as Per NCI CTCAE v4.0

    Summarized by descriptive statistics for each of the disease cohorts. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing.

    Measured: Up to 4 years

  5. Incidence of Severe (Grade 3+) Adverse Events or Toxicities as Per NCI CTCAE v4.0

    The incidence of severe (grade 3+) adverse events or toxicities will be described.

    Measured: Up to 4 years

  6. Tolerability of the Regimen Assessed Through Number of Patients Who Required Dose Modifications and/or Dose Delays

    Measured: Up to 4 years

  7. Proportion of Patients Who go Off Treatment Due to Adverse Reactions or Even Those Who Refuse Further Treatment for Lesser Toxicities That Inhibit Their Willingness to Continue Participation on the Trial

    Measured: Up to 4 years

Timeline

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

  1. First posted30 Jan 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2015
  4. Study completionMar 2016

Why it stopped: Low patient accrual

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02351505
Sponsor's protocol ID
OSU-14136
Other IDs
NCI-2014-02489
Status last verified
May 2016
First submitted
27 Jan 2015
Last updated
16 May 2016
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Selinexor, Laboratory Biomarker Analysis and Pharmacological Study in people with Recurrent Small Cell Lung Carcinoma, run by Erin Bertino 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 19 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: stopped early, as of the sponsor's last update on 16 May 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression Free Survival (time frame: Time from the date of study registration to the date of disease progression or to the date of last observation when no event (disease progression) has occurred, assessed up to 4 years). 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 NCT02351505.

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 16 May 2016.

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