Clinical trial NCT01027676 (phase 1/phase 2, status: unknown status)
Conditions: non-small-cell lung carcinoma
ICD codes: D02.20, D02.21, D02.22
Drugs: study treatment
SMILES: COC1=CC=CC=C1OC1=C(NS(=O)(=O)C2=CC=C(C=C2)C(C)(C)C)N=C(N=C1OCCO)C1=NC=CC=N1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic diagnosis of NSCLC, Stage IV or selected stage IIIB (with
             positive pleural effusion or multiple ipsilateral lung nodules) according to the
             American Joint Committee on Cancer (AJCC).

          -  Previously treated with at least one platinum-based chemotherapy.

          -  Before study entry, a minimum of 28 days must have elapsed since any prior
             chemotherapy.

          -  Prior radiation therapy is allowed as long as the irradiated area is not the only
             source of measurable disease.

          -  No other forms of cancer therapy, such as radiation, immunotherapy for at least 2
             weeks before the enrollment in study.

          -  Performance status of 0-2 on the ECOG criteria.

          -  At least one unidimensionally measurable lesion meeting Response Evaluation Criteria
             in Solid Tumors (Revised RECIST guideline version 1.1)

          -  Estimated life expectancy of at least 8 weeks.

          -  Patient compliance that allow adequate follow-up.

          -  Adequate hematologic (WBC count 4,000/mm3, platelet count 150,000/mm3), hepatic
             (bilirubin level 1.5 mg/dL, AST/ALT 80 IU/L), and renal (creatinine concentration 1.5
             mg/dL) function.

          -  Informed consent from patient or patient's relative.

          -  Males or females at least 18 years of age.

          -  If female: childbearing potential either terminated by surgery, radiation, or
             menopause, or attenuated by use of an approved contraceptive method (intrauterine
             device [IUD], birth control pills, or barrier device) during and for 3 months after
             trial. If male, use of an approved contraceptive method during the study and 3 months
             afterwards. Females with childbearing potential must have a urine negative hCG test
             within 7 days prior to the study enrollment.

          -  Patients with brain metastasis are allowed unless there were clinically significant
             neurological symptoms or signs

        Exclusion Criteria:

          -  Presence of small-cell lung cancer alone or with NSCLC

          -  Unresolved chronic toxic effects from previous anticancer therapy: but patient could
             be enrolled, if they have recovered from any treatment-related toxicities NCI CTCAE
             grade ≤2

          -  Inability to swallow tablets

          -  Second primary malignancy (except in situ carcinoma of the cervix or adequately
             treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years
             ago without recurrence).

          -  More than three previous chemotherapy regimens for NSCLC

          -  Previous treatment with any EGFR-TKI

          -  Patients who have been exposed to any prior HDAC inhibitor, with the exception of
             exception of valpronic acid used for treating seizures, provided there is a 30-day
             washout period

          -  Patients with active HIV or hepatitis B or C infection

          -  Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, cyclosporine A,
             valpronic acid, Phenobarbital, ketoconazole, coumarin-derivative anticoagulants or St
             John's wort; severe or uncontrolled systemic disease; clinically active interstitial
             lung disease (except uncomplicated lymphangitic carcinomatosis) pregnancy; and
             breastfeeding.

          -  MI within preceding 6 months or symptomatic heart disease, including unstable angina,
             congestive heart failure or uncontrolled arrhythmia

          -  Serious concomitant infection including postobstructive pneumonia

          -  Major surgery other than biopsy within the past two weeks.