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Determine MTD and to Evaluate PK, Safety/Tolerability and Efficacy Profiles of Antroquinonol (Hocena®) in NSCLC Patients Refractory to Conventional Treatment Modalities

Phase 1
20 Years
Open (Enrolling)
Non-small Cell Lung Cancer

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Trial Information

Determine MTD and to Evaluate PK, Safety/Tolerability and Efficacy Profiles of Antroquinonol (Hocena®) in NSCLC Patients Refractory to Conventional Treatment Modalities

1. Antroquinonol, a novel cyclohexenone compound, is a purified compound from extract of
Antrodia camphorata.

2. The pharmacological effects of antroquinonol were postulated to exert its
antitumorigenesis effects through interactions to primary targets of epidermal growth
factor receptor (EGFR)/Akt/mitogen-activated protein kinase (MAPK).

3. In vivo study in NOD/SCID mice with A549 subcutaneous xenografts consistently showed
tumor growth suppression after 2 weeks of oral 30 and 60 mg/kg antroquinonol treatment.

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine MTD and dose limiting toxicities (DLTs) of antroquinonol

Outcome Description:

There are two phases in this study, the accelerated titration phase and the standard titration phase. MT is defined as any grade 2 toxicity and DLT is defined as any grade 3 or above toxicity by the National Cancer Institute (NCI)Common Terminology Criteria for Adverse Event (CTCAE) version 4.03 as determined by the investigator to be at least possibly related in causality to the treatment. Nausea, vomiting and diarrhea of grade 3 or more are to be counted as DLT only if they remain at grade 3 or more despite adequate treatment.

Outcome Time Frame:

DLT is to be observed during 4 week period

Safety Issue:


Principal Investigator

Woei-Yau Kao, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tri-Service General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

December 2010

Completion Date:

June 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms