Influence of exceptional patient characteristics on everolimus exposure - INPRES

Radboud University Nijmegen Medical Centre0 个研究点目标入组 75 人开始时间: 2013年8月15日最近更新: 2018年11月12日

适应症

试验速览

暂无简介。

•- Adult women (= 18 years of age) with metastatic or locally advanced breast cancer not
•amenable to curative treatment by surgery or radiotherapy.
•- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
•- Postmenopausal women
•- Progression following a non-steroidal aromatase inhibitor
•- Radiological or clinical evidence of recurrence or progression on last systemic therapy prior to enrollment.
•- Falling into one of the following categories:
•o elderly patients (age = 70 years and BMI < 30 kg/m2); or
•o obese patients (BMI = 30 kg/m2 and age < 70 years); or
•o control patients (BMI < 30 kg/m2 and age < 70 years);
•- Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5 x ULN
•- Adequate renal function: calculated creatinine clearance (as estimated by GFR using the MDRD formula) is MDRD = 30ml/min/1.73m2
•- Performance status ECOG 0 - 2 (Karnofsky index: 60 - 100)
•- Patient is willing and able to sign the Informed Consent Form prior to screening evaluations
•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 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•- Patients aged = 70 years AND BMI = 30 kg/m2
•- HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive)
•- Previous treatment with exemestane or mTOR inhibitors. Except for the treatment with exemestane in the adjuvant setting
•- Known hypersensitivity to mTOR inhibitors, e.g. sirolimus (rapamycin)
•- Patients with a known history of HIV seropositivity
•- Any severe and / or uncontrolled medical condition such as:
•o Unstable angina pectoris, serious uncontrolled cardiac arrhythmia
•o Patients with severe hepatic impairment (Child-Pugh A/B/C)
•o Uncontrolled diabetes mellitus
•o Impairment of gastrointestinal function or gastrointestinal disease that may
•significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
•- Patients who test positive for hepatitis B or C (Patients who test negative for HBV-DNA, HBsAg, and HBcAb but positive for HBsAb with prior history of vaccination against Hepatitis B will be eligible). Only patients at higher risk for hepatitis B or C have to be tested.
•- Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment
•- History of non-compliance to medical regimens or patients unwilling to or unable to comply with the protocol

发起方

Radboud University Nijmegen Medical Centre