Pancreatic cancer
Conditions
Interventions
Product Name: Z-360
Pharmaceutical Form: Coated tablet
Current Sponsor code: Z-360
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
ZERIA Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 20 to 70 years. • Provide written informed consent. • In the investigator’s opinion, the subject has the ability to co-operate with the treatment and follow up procedures. • Subjects with unresectable locally advanced (histologically/cytologically verified) or metastatic pancreatic cancer. • Subjects must have at least one measurable lesion. • No other primary neoplasms apart from pancreatic cancer. • Life expectancy of at least 3 months. • Karnofsky Performance Status of =70%. • Adequate liver and renal function as defined by: serum creatinine (=133 µmol/L); total bilirubin levels (=34.2 µmol/L); AST or ALT levels =3 times the upper limit of the reference range (or =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women. Female subjects of child-bearing potential are eligible, provided they have a negative urine pregnancy test prior to enrolment and agree to use medically approved contraceptive precautions for 4 weeks prior to entering the study and for 6 months afterwards. Male subjects must agree to use barrier contraception during the trial and for 6 months afterwards or be surgically sterile. • Concurrent serious infections (ie requiring an intravenous antibiotic). • An unstable or concurrent serious medical condition. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent. • Major surgery within the past 14 days. • Participation in any other clinical study within the previous 30 days or during the course of this study. • Any contraindications to the administration of gemcitabine. • Received previous chemotherapy for the current indication. • Received previous radiotherapy for the current indication. (ie if the irradiated area was the only source of measurable or assessable disease). • Currently receiving chemotherapy. • Currently receiving treatment with a PPI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the safety of two doses of Z-360 with gemcitabine administration for subjects with unresectable advanced pancreatic cancer in order to determine the optimal dosage for Phase II study. 2. To determine the pharmacokinetic parameters of Z-360 in subjects with pancreatic cancer. ; Secondary Objective: 1. To evaluate the drug-drug interaction between Z-360 and gemcitabine. 2. To evaluate the efficacy of Z-360 by the objective tumour response rate. 3. To evaluate the effect of Z-360 on subject quality of life as measured by a quality of life questionnaire. ;Primary end point(s): Completion of the 12-week treatment and 4-week follow up period. | — |
Countries
Belgium, United Kingdom
Outcome results
None listed