E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Age 20 years and over. • 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 <5 times in the presence of liver metastases). • Adequate bone marrow function defined by a white blood cell (WBC) count of ≥3.5 x 109/L, an absolute neutrophil (ANC) count of ≥1.5 x 109/L, a platelet count of ≥100 x 109/L and a haemoglobin level of ≥9.5 g/dL. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Completion of the 12-week treatment and 4-week follow up period. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 3 |