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Clinical Trials/EUCTR2017-002437-36-IT
EUCTR2017-002437-36-IT
Active, not recruiting
Phase 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

CENTRO DI RIFERIMENTO ONCOLOGICO0 sites58 target enrollmentSeptember 7, 2021
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ConditionsPatients with gastrointestinal stromal tumourMedDRA version: 20.0Level: LLTClassification code 10062427Term: Gastrointestinal stromal tumorSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsGLIVEC - 100 MG 120 CAPSULE RIGIDE USO ORALE

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Patients with gastrointestinal stromal tumour
Sponsor
CENTRO DI RIFERIMENTO ONCOLOGICO
Enrollment
58
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 7, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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