Predictive value of ABCB1 genotypes on dose adjustment of imatinib in patients with GIST (Gastro-Intestinal Stromal Tumour) and CML (Chronic Myeloid Leukaemia)

Not Applicable

• Conditions: Patients revieving treatment with imatinib, currently CML (Chronic Myeloid Leukaemia) and GIST (Gastro-Intestinal Stromal Tumour); Cancer - Leukaemia - Chronic leukaemia

• Registration Number: ACTRN12606000117516
• Lead Sponsor: Investigator Initiated - A/Professor Howard Gurney and Dr Josef Klumpen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-04-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

ECOG 0, 1 or 2 at start of treatment with imatinib• Medication records of the first 3 months ± 14 days of treatment must be available • Starting dose needs to be either greater than or equal to 600 mg or starting dose of 400 mg if there was a dose reduction required due to toxicity within the first 3 months period of treatment with imatinib• No chemotherapy, biological treatment or any other investigational drug within 28 days of treatment start• Adequate haematological function as determined within the preceeding14 days, ANC >/= 1.5 x109/l as well as Platelets >/= 100 x109/l• Adequate liver and renal function defined as serum bilirubin concentration less than 1.5 x ULN, AST and ALT less than 2.5 x ULN, serum creatinine concentration less than 1.5 x ULN• No known primary liver disease and no other severe or uncontrolled concurrent medical condition within the first 3 months of treatment with imatinib.• Patients who have participated on other clinical studies of imatinib will be suitable for this study.• Being treated with Imatinib for more than 10 weeks • Signed informed consent.

Exclusion Criteria

Patients who are unable to sign informed consent• Patients who have had less than 400 mg of imatinib at start of treatment• Patient included in the initial Glisest study • Patients unable to give blood• Patients who had a bone-marrow-transplantation prior to imatinib treatment• Patients who had no blood sample taken and available for genotyping prior to bone-marrow-transportation.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether ABCB1 genotype correlates with toxicity-adjusted dose of imatinib[At 3 months +/- 14 days]

Secondary Outcome Measures

Name	Time	Method
To examine correlations between ABCB1 genotype and toxicity grade according to CTC criteria.[Timepoint is 3 months +/- 14days.];To examine the correlation between toxicity-adjusted dose and CTC toxicity criteria with genotype of other drug elimination genes such as organic anion transporter proteins (OATP) and other biliary efflux proteins such as MRP2, BCRP and other drug elimination genes that may be found to be important in the future.[Timepoint is 3 months +/- 14days.];To confirm findings from a previous study.[Timepoint is 3 months +/- 14days.]