| Eligibility |
Inclusion Criteria
Subjects must meet all inclusion criteria as listed below:
1. Histologically or cytologically confirmed, locally advanced or metastatic solid
malignancies, such as non-small cell lung cancer (NSCLC), breast cancer,
hepatocellular carcinoma, colorectal, prostate and pancreatic cancer who is not
suitable for surgery or radiotherapy.
2. Subjects who have progressed after receiving all available standard treatment known to
confer clinical benefit or for which no effective therapy exists.
3. Radiological documentation of disease progression while on a previous treatment.
4. Discontinued all previous treatment for cancer for at least 14 days and recovered from
the effects of therapy.
5. Eastern Cooperative Oncology Group (ECOG) 0 ~ 1
6. 19 years and older of age (Adult)
7. At least one measurable lesion by Response Evaluation Criteria in Solid Tumours
(RECIST 1.1)
8. Laboratory values: Hematologic parameters must be met without recent transfusions
within 7 days of enrolment.
1. Serum creatinine < 1.5× upper limit of normal (ULN) or if higher than normal
range, calculated creatinine clearance (CrCl) must be = 60mL/min/1.73m2 (by
Cockroft-Gault formula); actual body weight must be used for CrCl unless body
mass index (BMI) > 30kg/m2 then lean body weight must be used
2. Total bilirubin = 1.5×ULN (except for Gilbert's syndrome which will allow
bilirubin =2.0 ×ULN).
3. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5×ULN, or = 5×ULN
if due to liver involvement by tumour.
4. Haemoglobin = 9.0g/dL.
5. Platelets = 100×109cells/L.
6. Absolute neutrophil count = 1.5×109cells/L.
9. Subjects signed informed contents form
10. Expected lifespan = 3 months
11. Female should be using adequate contraceptive measures, e.g., use at least two of the
following types of appropriate and effective birth control from 2 weeks prior to the
first dose of the study drug until 90 days after last dose. One of these methods must
be a double barrier method (condom with diaphragm plus spermicidal agent
[foam/gel/cream/film/suppository]). Additional methods are IUD or IUS, vasectomy by
sole male partner and use of approved oral, injected, or implanted hormonal methods of
contraception.
12. Female should not breast feeding and must have a negative pregnancy test prior to
start of dosing if of child-bearing potential or must have evidence of
non-child-bearing potential at screening.
13. Male subjects should be willing to use barrier contraception include using one of the
following during the study and for 90 days after last dose of the study drug.
(Abstinence, condom plus spermicidal agents [foam gel/cream/film/suppository])
Exclusion Criteria Any subject meeting one or more of the following exclusion criteria may
not be entered into the trial.
1. Symptomatic central nervous system (CNS) metastases which are neurologically unstable
or requiring increasing doses of steroids within the 28 days prior to study entry to
control their CNS disease and require local CNS-directed therapy
2. Systemic anticancer treatment 14 days prior to the first dose of study drug on Visit 1
3. Subjects who have undergone any major surgery* (as judged by the investigator,
excluding placement of vascular access) = 28 days of the first dose of study drug on
Visit 1 or who have not recovered from side effects of such therapy
*Major surgery defined as a surgical operation within or upon the contents of the
abdominal, pelvic, cranial or thoracic cavities and a procedure which given the
locality, condition of patient, level of difficulty or length of time to perform,
constitutes a hazard to life or function of an organ or tissue. Major surgery usually
requires general anesthesia, a period of hospitalization of varying length (often a
week) and may be performed by a surgical subspecialist.
4. Limited-field radiotherapy = 7 days or extended-field thoracic radiotherapy < 28 days
of study drug on Visit 1
5. Subjects with
1. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration
of a QTc interval > 480 milliseconds (ms) (CTCAE grade 1) using Frederica's QT
correction formula.
2. A history of additional risk factors for TdP (e.g., heart failure, hypokalemia,
family history of Long QT Syndrome).
3. The use of concomitant medications that prolong the QT/QTc interval.
6. Subjects with impaired cardiac function or clinically significant cardiac disease such
as:
1. Left ventricular ejection fraction < 50%.
2. Clinically significant and/or uncontrolled heart disease such as congestive heart
failure requiring treatment (NYHA Grade = 2), uncontrolled hypertension, or
clinically significant arrhythmia.
3. History of acute myocardial infarction or unstable angina pectoris < 6 months
prior to study entry.
7. Subjects who had a prior history of another malignancy over the last 5 years
8. Subjects able to swallow and retain orally administered medication and does not have
any clinically significant gastrointestinal abnormalities that may alter absorption
such as malabsorption syndrome or major restriction of the stomach or bowels
9. Subjects with active human immunodeficiency virus (HIV) or hepatitis B or C infection
10. Subjects who were administered another investigational product within 3 weeks prior to
screening
11. Subjects with any unresolved toxicity of Grade = 2 from previous anti-cancer
treatment, except for alopecia and skin pigmentation.
12. Subjects with any clinically significant abnormal intestinal findings that may
interfere with the administration, passage, or absorption of the investigational
product, which makes the subjects unable to orally take the suspension form of drugs.
13. Subjects with drug abuse and unstable medical, psychological or social conditions that
may interfere with participating in the study or assessment of the results of the
study
14. Subjects with any condition or illness might compromise subject safety or interfere
with the evaluation of the safety of the drug by investigator's decision
15. Males and females of reproductive potential who are not using an effective method of
birth control and females who are pregnant or breastfeeding or have a positive (urine
or serum) pregnancy test prior to study entry
16. According to investigator's judgement, protocols cannot be followed.
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