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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 November 2015
• Main ID: NCT02536495
• Date of registration: 27/08/2015
• Prospective Registration: Yes
• Primary sponsor: Erin Bertino
• Public title: Selinexor and Docetaxel in Treating Patients With Recurrent or Metastatic Squamous Cell Lung Cancer
• Scientific title: An Investigator-Sponsored Phase 1/2 Study of Selinexor (KPT-330) and Docetaxel as Second Line Therapy in Patients With Relapsed Squamous Cell Lung Cancer
• Date of first enrolment: September 2015
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02536495
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Erin Bertino, MD
• Affiliation: Ohio State University Comprehensive Cancer Center

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- Resolution to grade =< 1 by National Cancer Institute Common Terminology Criteria for
Adverse Events version 4.03 (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)

Exclusion Criteria:

- 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

- Concurrent therapy with approved or investigational anticancer therapeutic other than
steroids

- Patients with coagulation problems and active bleeding in the last month (peptic
ulcer, epistaxis, spontaneous bleeding)

- Uncontrolled brain metastases; patients with brain metastases are permitted if they
have received appropriate therapy and demonstrated control of the brain metastases
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])

- Renal failure requiring hemodialysis or peritoneal dialysis

- Patients with significantly diseased or obstructed gastrointestinal tract,
malabsorption, uncontrolled vomiting or diarrhea or inability to swallow oral
medications

- Patients who are severely underweight in the opinion of the investigator

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Stage IV Squamous Cell Lung Carcinoma

Recurrent Squamous Cell Lung Carcinoma

Intervention(s)

Drug: Selinexor

Other: Laboratory Biomarker Analysis

Other: Pharmacological Study

Drug: Docetaxel

Primary Outcome(s)

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 3 years]

Secondary Outcome(s)

Objective response rate (complete response [CR] or partial response [PR] by RECIST) [Time Frame: Up to 1 year]

Disease control rate (Complete Response + Partial Response + stable disease) [Time Frame: Up to 1 year]

Overall survival [Time Frame: 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]

Incidence of adverse events, graded according to the National Cancer Institute CTCAE version 4.03 [Time Frame: Up to 1 year]

Secondary ID(s)

NCI-2015-01165

OSU-14152

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Karyopharm Therapeutics, Inc