E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with any malignancy who have previously been evaluated in a SU001248 protocol |
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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 objective is to provide access to SU011248 treatment for patients who have partecipated in other SU011248 protocol and have the potentila to derive clincial benefit from SU011248 tretament as judged by teh investigator. |
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E.2.2 | Secondary objectives of the trial |
- To assess the safety profile of SU011248 - To continue follow-up of efficacy endpoints of interest in previous SU011248 studies contributing to this protocl. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Partecipated ina previous SU011248 protocol and are judged by the investigator to have the potential to derive clinical benefit from SU011248 treatment 2. Signed and dated informed consent document indicating that the patient (or
legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment. 3. Enrollment within 8 weeks from their last dose of SU011248 or placebo in their previous study. 4. Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures.
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E.4 | Principal exclusion criteria |
Subjects presenting with any of the following will not be included in the trial: 1. Current treatment in another clinical trial 2. Pregnancy or breastfeeding 3. Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
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E.5 End points |
E.5.1 | Primary end point(s) |
This is an open-label “study . Disease assessments for tumor response and progression will be done for data collection on selected patients ; specifically, patients who previously participated in a study for which objective disease response or time-to-progression was a study endpoint. For individual patients enroling from protocols that included a survival endpoint, follow-up survival information will be collected every 2 months until death or up to 2 years from the date of the last dose of SU011248
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| 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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Patients may continue to access SU011248 on this protocol as long as there is evidence of disease control in the judgment of the investigator. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |