E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10053548 |
E.1.2 | Term | Gastrointestinal cancer metastatic |
|
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 |
Primary: to evaluate whether surgery of residual disease in patients with advanced GIST responding to imatinib improves the progression free survival. |
|
E.2.2 | Secondary objectives of the trial |
Secondary: to correlate the pharmacokinetics of imatinib and its metabolites in both the experimental (surgery) and standard (non-surgery) treatment arms, with the pharmacokinetics of imatinib and metabolites preceding randomisation. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
š Histologically confirmed GIST expressing CD117+, or with documented mutation of the KIT or PDGFRA gene š Metastatic disease (liver and/or abdominal cavity); no extra-abdominal metastases š Treatment with imatinib administered for 6-12 months, resulting in CR, PR or SD, without PD since the start of Imatinib therapy (RECIST) š No prior treatment with imatinib or other tyrosine kinase inhibitors (for any reason) in the adjuvant or neoadjuvant setting š Measurable disease (RECIST) before start of imatinib š Surgically resectable residual disease (assessed on CT scan/ MRI) š Age ≥ 18 years; performance status 0 to 1 (WHO scale) š Adequate hematologic and organ function |
|
E.4 | Principal exclusion criteria |
-myocardial infarction, unstable or uncontrolled cardiac disease within 6 months of study entry -uncontrolled hypertension (DBP>95 mm Hg; SBP>170 mm Hg) -history of arterial thrombosis or deep vein thrombosis within 1 year of study entry - bleeding diathesis, coagulopathy or major bleeding within 6 months of study entry - coumadin-type anticoagulant > 2mg/day within 7 days of study entry -major surgery within 28 days of study entry -prohibited co-medication which interacts moderately or strongly with the CYP3A system within 14 days of study entry (see detailed list on http://medicine.iupui.edu/flockhart/table.htm), until both pharmacokinetic samples are taken. - severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled diabetes, uncontrolled chronic renal disease, uncontrolled liver disease, including chronic viral hepatitis judged at risk of reactivation, uncontrolled active infection, such as HIV infection, etc.). - prior malignancy (other than in situ cervical cancer, in situ melanoma, or basal or squamous cell cancer of the skin) unless treated with curative intent and without evidence of disease for at least 3 years špregnancy - any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Primary: to evaluate whether surgery of residual disease in patients with advanced GIST responding to imatinib improves the progression free survival. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | 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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
chirurgia+ farmaco vs farmaco |
|
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 50 |
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 8 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial months | 0 |