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

Investigator Initiated - A/Professor Howard Gurney and Dr Josef Klumpen0 个研究点目标入组 300 人开始时间: 2006年4月3日最近更新: 2020年1月13日

适应症

试验速览

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•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.

•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.

发起方

Investigator Initiated - A/Professor Howard Gurney and Dr Josef Klumpen