E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Locally advanced, non-resectable pancreatic cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052747 |
E.1.2 | Term | Adenocarcinoma pancreas |
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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 |
Exploratory proof of concept study to assess the anti-tumor activity of two different doses of WX-671 when given in combination with gemcitabine. |
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E.2.2 | Secondary objectives of the trial |
Safety and Pharmacokinetics. The following safety and tolerability variables will be measured i. Vital signs ii. ECG iii. Biochemistry iv. Hematology (including coagulation) v. Adverse events |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
FARMACOCINETICA/FARMACODINAMICA: Versione: Data: Titolo:uPA marker Obiettivi:
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E.3 | Principal inclusion criteria |
1. Locally advanced, unresectable, non-metastatic, histologically proven pancreatic adenocarcinoma (lymph nodes will not be considered metastases) 2. Male or female subjects age ≥ 18 years 3. ECOG performance status ≤ 1 4. Life expectancy > 12 weeks 5. Signed and dated informed consent form 6. Patient able to participate, communicate well with the investigator and willing to give informed consent and comply with the study restrictions 7. Normal 12-lead ECG or only clinically insignificant abnormalities in the judgment of the investigator 8. Female patients of child-bearing potential will be required to use an effective method of birth control for the duration of the study to prevent pregnancy. Acceptable methods include implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or sterilization (including vasectomy of partner). 9. Laboratory parameters (obtained within the screening period): neutrophils ≥ 1.5x109/L platelets ≥ 100 x109/L Hgb ≥ 9 g/dL) total bilirubin ≤ 1.5 x ULN ASAT/ALAT/AP ≤ 2.5 x ULN serum creatinine ≤ 2 x ULN. (calculated creatinine clearance > 45 ml/min) |
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E.4 | Principal exclusion criteria |
1. Any distant metastases 2. History of or current primary blood coagulation or bleeding disorders such as hemophilia 3. Anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except low dose anticoagulant therapy with unfractionated heparin ≤ 15000 IU/d, low molecular weight heparin ≤ 5000 IE anti-Xa activity or acetyl salicylic acid ≤ 100 mg/d at the discretion of the investigator) 4. Any unrelated illness, e.g., active infection, inflammation, medical condition or laboratory abnormalities, which in the judgment of the investigator might significantly affect the patients study participation 5. Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug 6. Significant cardiac insufficiency (NYHA classification III or IV), presence of unstable angina or myocardial infarction within the previous 6 months, use of ongoing maintenance therapy for lifethreatening arrhythmia or known pulmonary hypertension 7. Any secondary malignancies within the last 5 years except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ 8. Pregnancy (positive serum pregnancy test) or lactation 9. Known Hepatitis B/C or HIV infection 10. Known hypersensitivity to any of the components in the WX-671 capsules or gemcitabine infusion or other medical reasons for not being able to receive adequate pre-medication (for example, antihistamine or anti-inflammatory agents) |
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E.5 End points |
E.5.1 | Primary end point(s) |
A number of variables will be explored to identify those whose effect may demonstrate activity of the combination of WX-671 and gemcitabine. The following efficacy variables will be measured: i. Response rate ii. Progression free survival iii. Time to first metastasis iv. Overall survival v. Tumor and uPA system related marker |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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) | Yes |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
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 | 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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Tossicita` inaccettabile; Decisione del medico/Sponsor nell`interesse del paziente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |