Determine MTD and to Evaluate pk, Safety/Tolerability and Efficacy Profiles of Hocena® in NSCLC Subjects
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Antroquinonol
Intervention description: Antroquinonol was taken orally, daily, within 15 minutes after a breakfast at the assigned dose level: 50, 100, 200, 300, 450, 600 mg/day for 4 weeks.
Dose Level 1 (4 weeks) : 50 mg Antroquinonol; Dose Level 2 (4 weeks) : 100mg Antroquinonol; Dose Level 3 (4 weeks) : 200mg Antroquinonol; Dose Level 4 (4 weeks) : 300mg Antroquinonol; Dose Level 5 (4 weeks) : 450mg Antroquinonol; Dose Level 6 (4 weeks) : 600mg Antroquinonol.
The accelerated phase ended when either 1 DLT or MT was observed to start standard phase. Study ended when reach the highest dose level or DLT founded.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Lung cancer; NSCLC

Summary:

      A phase I study to determine the maximum tolerable dose (MTD) and to evaluate
      pharmacokinetic, safety/tolerability and efficacy profiles of antroquinonol (Hocena®) in
      non-small cell lung cancer (NSCLC) subjects refractory to conventional treatment modalities
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age ≥ 20 years.

          2. Diagnosed stage III/IV NSCLC. The grading is determined according to the
             Tumor-Node-Metastasis (TNM) staging system for lung cancer.

          3. Patients with histologically or cytologically proven primary NSCLC with adenocarcinoma
             or mixed cell type with adenocarcinoma, who have failed on standard treatments.

          4. With progressive tumor after two lines of chemotherapy (including one platinum-based)
             and 1 EGFR-targeted therapy if patient is identified with EGFR mutation or his/her
             EGFR mutation status is unknown OR having refused further currently approved treatment
             modalities.

          5. Life expectancy ≥ 3 months.

          6. Within 1 week of planned first study treatment day, adequate hematopoietic functions
             are presented: Total white blood cell (WBC) ≥ 3500 cells/mm3 Hemoglobin (Hb) ≥ 9.0
             g/dL Platelets ≥ 100,000 cells/mm3 Absolute neutrophil count (ANC) ≥ 1500 /mm3

          7. Within 1 week of planned first study treatment day, adequate hepatic and renal
             functions are presented: Total bilirubin ≤2.0 mg/dLGOLANTA20090911, Amendment 4/v.
             1.0/ 13 October 2010 AST ≤ 3 × upper limit of normal (ULN); patients with liver
             metastasis: AST ≤ 5 × ULN ALT ≤ 3 × ULN; patients with liver metastasis: ALT ≤ 5 × ULN
             Creatinine ≤ 1.5 mg/dL

          8. Must have recovered from toxicities of previous anti-cancer treatments to grade 1
             NCI-CTC or better, except for alopecia.

          9. Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2.

         10. Female patient with childbearing potential confirmed of not being pregnant at the
             screening; and informed that effective contraception must be used during the entire
             treatment period of this study and for 6 months after exiting from the study.

         11. Given signed and dated written informed consent form.

        Exclusion Criteria:

          1. Primary major surgery < 4 weeks prior to the planned first study treatment day.

          2. Lactating, pregnant or plans to be become pregnant.

          3. Except for alopecia, recovered from any previous treatments to a grade 1 or less prior
             to the planned first study treatment day.

          4. With active systemic infections, active and clinically significant cardiac diseases,
             active gastrointestinal ulcers, or medical conditions that may significantly affect
             adequate absorption of investigational product.

          5. Within 5 years, prior history of malignancy other than NSCLC, except cervical
             carcinoma in situ and basal or squamous cell skin carcinoma.

          6. Known allergic to antroquinonol or its formulation excipients.

          7. Within 14 days of planned first study treatment day, exposed to any drug(s) known to
             be significant CYP2C19, 3A4, 2C8, and 2E1, inhibitor or activator.

          8. With conditions judged by the investigator as unsuitable for the study.