E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced malignancies of the lung, pancreas, or prostate. |
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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 |
The primary efficacy objective is to evaluate the effects of an intermittent schedule of nadroparin on death due to all causes in patients with advanced malignancies of the lung, pancreas, or prostate. The principal safety outcome is major bleeding. |
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E.2.2 | Secondary objectives of the trial |
The secondary efficacy objective is to determine the effects of an intermittent schedule of nadroparin on time to progression. The additional safety outcome is clinically relevant bleeding (i.e. major bleeding and other clinically relevant non-major bleeding). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
A subject will be eligible for this study only if the following criteria apply: 1. Patients with HRPC within 6 months of diagnosis of hormone-refractory status, locally advanced pancreatic cancer or NSCLC (without clinically significant pleural effusion on chest X-ray) within 3 months of diagnosis of stage IIIB. 2. Men and women aged ≥18 years. 3. Informed consent.
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E.4 | Principal exclusion criteria |
1. Life expectancy of less than 3 months; 2. Karnofsky preformance status <60; 3. Indication for anticoagulant treatment; 4. Any contraindication listed in the local labeling of nadroparin; 5. Documented history of heparin-induced thrombocytopenia with UFH or LMWH; 6. Severe thrombocytopenia (<50,000 / mm3); 7. Current active bleeding or judged to be as high risk of bleeding; 8. Documented brain metastasis; 9. Creatinine Clearance <30 mL/min; 10. Pregnancy; 11. Women of child-bearing potential not using effective means of contraception; 12. The subject participated in another clinical trial using an investigational product within one month before randomization. 13. In France, a subject is neither affiliated with nor a beneficiary of a social security category. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy
The primary efficacy outcome is death due to all causes.
Safety
The principal safety outcome is major bleeding. |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | Yes |
E.8.2.3.1 | Comparator description |
No comparator. The trial will compare nadroparin with no nadroparin. |
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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 | 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 | 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
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The end of the trial is the last study treatment period visit of the last patient. |
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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 | 2 |
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 | 2 |