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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective is to assess the biological activity of CP-4126 in patients with advanced pancreatic cancer.
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E.2.2 | Secondary objectives of the trial |
Additional objectives is to assess
- the correlation between hENT1 (human equilibrative nucleoside transporter 1) and overall survival - safety profile
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histological or cytological confirmed advanced pancreatic cancer* 2. Not eligible for curative resection 3. Performance status (ECOG) 0-2 4. Estimated life expectancy of at least 12 weeks 5. Age ≥ 18 years 6. Adequate haematological and biological functions: • Bone marrow function: a. Neutrophils ≥ 1.5 x 109/L b. Platelets > 100.0 x 109/L c. Hb ≥ 10 g/dL • Hepatic function: a. AST/ALT and alkaline phosphatase (ALP) ≤ 2.5 x institutional upper limit of normal (ULN), if liver metastases; AST/ALT ≤ 5 x institutional ULN and ALP ≤ 4 x institutional ULN b. Bilirubin ≤ 1.5 times institutional ULN, if liver metastases ≤ 3 x institutional ULN • Renal function: a. Serum creatinine ≤ 1.5 times institutional ULN 7. Signed informed consent *When feasible, the biopsy for diagnosis and hENT1 can be combined, so that the patient only needs to have one biopsy performed
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E.4 | Principal exclusion criteria |
1. Prior chemotherapy for metastatic disease 2. Symptomatic brain metastases 3. Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study 4. Requirement of concomitant treatment with a non-permitted medication, including high doses of vitamins and alternative drugs 5. History of allergic reactions to gemcitabine or egg 6. Presence of any serious concomitant systemic disorders incompatible with the clinical study (e.g. uncontrolled inter-current illness including ongoing or active infection) 7. Presence of any significant central nervous system or psychiatric disorder(s) that would hamper the patient’s compliance 8. Pregnant or breastfeeding women 9. Absence of adequate contraception for both male and female fertile patients for the duration of the study; and also for three months after last treatment 10. Known positive status for HIV 11. Any reason why, in the investigator’s opinion, the patient should not participate in the study. 12. Drug or alcohol abuse 13. Prior radical resection, but exploratory laparotomy as well palliative (e.g. bypass) surgery are allowed
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E.5 End points |
E.5.1 | Primary end point(s) |
• Overall survival (OS); relation between hENT1 expression level and survival • Objective response rate (ORR) according to Response Evaluation Criteria In Solid Tumours (RECIST) in patients with measurable disease. Changes in the tumour marker, CA19-9 will also be considered. • Safety profile • Feasibility: patient acceptance, biopsy sampling and analysis
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
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 | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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
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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 | 6 |
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 | 6 |