Selinexor and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Lung Cancer

NCT02536495 | Withdrawn Phase 1 DMC

• 2 other identifiers: OSU-14152NCI-2015-01165
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase I/II trial studies the side effects and best dose of selinexor and docetaxel and to see how well they work when given together in treating patients with squamous cell lung cancer that has come back or spread to other places in the body. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving selinexor together with docetaxel may work better in treating squamous cell lung cancer.

Conditions

Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  PFS will be estimated by the method of Kaplan and Meier (KM). Appropriate one-sided 90% confidence boundary will also be calculated for the final test KM 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 3 years

Secondary Outcomes (4)

• Disease control rate (Complete Response + Partial Response + stable disease)

  Up to 1 year

• Incidence of adverse events, graded according to the National Cancer Institute CTCAE version 4.03

  Up to 1 year

• Objective response rate (complete response [CR] or partial response [PR] by RECIST)

  Up to 1 year

• 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 3 years

Other Outcomes (1)

• Changes in tumor suppressor protein expression levels

  Baseline to up to course 2, day 1

Study Arms (1)

Treatment (docetaxel, selinexor)

EXPERIMENTAL

Patients receive docetaxel IV on day 1 and selinexor PO BID on days 1, 3, 7, 9, 13, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

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

Interventions

Docetaxel DRUG

Given IV

Also known as: RP56976, Taxotere, Taxotere Injection Concentrate

Treatment (docetaxel, selinexor)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (docetaxel, selinexor)

Pharmacological Study OTHER

Correlative studies

Treatment (docetaxel, selinexor)

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 (docetaxel, 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 recurrent or metastatic squamous cell carcinoma of the lung - 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 at least 1 platinum-based chemotherapy regimen, but no more than 2 cytotoxic chemotherapy regimens in the setting of recurrent or metastatic disease; the regimen(s) may have included biological, molecularly targeted or immune therapies; adjuvant chemotherapy is considered 1 cytotoxic chemotherapy regimen if the last administration occurred \< 1 year prior to entry
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Absolute neutrophil count (ANC) \> 1500/mm\^3
• Platelets count \> 100,000 mm\^3 and less than 1,000,000 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; patients with \> 3 liver metastases at enrollment will be excluded
• Estimated creatinine clearance of \>= 30 mL/min, calculated using the formula of Cockcroft and Gault
• Amylase =\< 1.5 x ULN
• Lipase =\< 1.5 x ULN
• Alkaline phosphatase limit =\< 2.5 x ULN
• Female patients of child-bearing 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 throughout the study and for three months following the last dose of selinexor

You may not qualify if:

• Patients who are pregnant or lactating
• Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =\< 2 weeks prior to cycle 1 day 1
• Prior treatment with selective inhibitor of nuclear export (SINE) inhibitor
• Major surgery within four weeks before cycle 1, day 1
• Unstable cardiovascular function:
• Electrocardiography (ECG) abnormalities requiring treatment, or
• Congestive heart failure (CHF) of New York Heart Association (NYHA) class \>= 3
• Myocardial infarction (MI) within 3 months
• 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)
• Any underlying condition that would significantly interfere with the absorption of an oral medication
• Patients with markedly decreased visual acuity
• Serious psychiatric or medical conditions that could interfere with treatment
• Participation in an investigational anti-cancer study =\< 3 weeks prior to cycle day 1

Sponsors & Collaborators

• Erin Bertino: lead
• Karyopharm Therapeutics Inc: collaborator

Related Links

• The Jamesline

MeSH Terms

Interventions

Docetaxel; selinexor

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Erin Bertino, MD

  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: August 27, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2018
• Last Updated: October 30, 2015

Record last verified: 2015-10