Selinexor in Treating Patients With Relapsed Small Cell Lung Cancer

NCT02351505 | Terminated Phase 2 Results DMC

• 2 other identifiers: OSU-14136NCI-2014-02489
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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. Selinexor works by trapping "tumor suppressing proteins" within the cell and may cause the cancer cells to die or stop growing.

Conditions

Recurrent Small Cell Lung Carcinoma

Keywords

Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (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.

  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)

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

  Up to 4 years

• Disease Control Rate (CR, PR, and Stable Disease)

  Up to 4 years

• Overall Survival

  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

• 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

  Up to 4 years

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

  Up to 4 years

Study Arms (1)

Treatment (selinexor)

EXPERIMENTAL

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

Drug: Selinexor; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

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)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (selinexor)

Pharmacological Study OTHER

Correlative studies

Also known as: pharmacological studies

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 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
• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Erin Bertino: lead
• Karyopharm Therapeutics Inc: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

selinexor

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Trial was closed early due to slow accrual.

Results Point of Contact

• Title: Erin Bertino, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Erin.Bertino@osumc.edu

614-293-8054

Study Officials

• Erin Bertino, MD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 27, 2015
• First Posted: January 30, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: May 16, 2016
• Results First Posted: May 16, 2016

Record last verified: 2016-05

Locations

US (1)