Effect of liver metastases from gastrointestinal stromal tumour (GIST) on imatinib pharmacokinetics

Completed

• Conditions: Gastrointestinal stromal tumour (GIST); Cancer; Malignant neoplasm of other and ill-defined digestive organs

• Registration Number: ISRCTN63855172
• Lead Sponsor: Azienda Unita Sanitaria Locale Di Ravenna (Italy)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of GIST or CML
2. Indication for imatinib treatment
3. Aged greater than or equal to 18 years, either sex
4. Performance status (Karnofsky scale): 60 to 100
5. Written informed consent
6. Adequate haematological functions (absolute neutrophil count [ANC] greater than 1.5 x 10^9/L, platelets greater than 100 x 10^9/L)
7. Adequate renal functions (creatinine less than 120 µmol/L or calculated clearance [Cockroft method] greater than 65 mL/min)
8. Bilirubin less than 5 times upper limit of normal (UNL)
9. Complete work-up within 2 - 4 weeks prior to therapy

Exclusion Criteria

1. Pregnant or lactating patients; patients must use adequate contraceptive if required
2. Patients pretreated with imatinib
3. Symptomatic central nervous system (CNS) metastases
4. Other serious illness or medical unstable condition requiring treatment or history of psychiatric disorder that would prohibit the understanding and giving of informed consent
5. Previous history of severe cardiovascular disease
6. Major surgery within the last 2 weeks before start of the protocol
7. Unwillingness to change medication, or no adequate alternatives available, when drugs, which are known to interact with liver CYP450 3A4/5 enzyme system, are taken

Study & Design

• Study Type: Observational
• Study Design: Not specified