EUCTR2017-002437-36-ITActive, not recruitingPhase 1
Pilot study to evaluate the feasibility of an innovative approach to monitor patients with gastrointestinal stromal tumour treated with imatinib - Innovative approach to monitor GIST patients treated with imatinib
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Enrollment
- 58
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Histologically or cytologically confirmed diagnosis of metastatic GIST eligible for imatinib treatment according to the routine clinical practice criteria; Age =18; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate liver, renal and bone marrow functions; Life expectancy > 3 months; Just for patients already on-treatment with imatinib, the therapy must be initiated more than 3 months prior to the first sample collection (to reach a stable blood drug concentration); Signed informed consent and local Ethical Committee (EC) approval availability; All patients in fertile age must have been under contraceptive treatment;
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
Exclusion Criteria
- •Pregnancy status; Refusal of informed consent; non-collaborative and/or unreliable patients; Patients who could not attend periodic clinical check-ups.
Investigators
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