EUCTR2005-003591-38-ES进行中（未招募）1 期
Ensayo en fase II, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ZD6474 en combinación con Arimidexâ?frente a Arimidexâ?solo como tratamiento de segunda línea en pacientes con cáncer de mama avanzado (CMA) hormonosensible (receptores de estrógeno positivos y/o receptores de progesterona positivos).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Provision of informed consent
- •2. Post menopausal females aged 18 years or older
- •Post menopausal defined as patients with:
- •- Natural menopause with menses>1 year ago
- •- Radiation induced oophorectomy with last menses>1 year ago
- •- Chemotherapy induced menopause with last menses>1 year ago
- •- Serum FSH, LH and plasma oestradiol levels in the postmenopausal range for the
- •institution
- •- Bilateral oophorectomy
- •3. Females with histological/cytological confirmation of breast cancer
- •4. Patients fulfilling one of the following criteria:
- •a) At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumours (RECIST)
- •b) Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease (as defined by RECIST).
- •5. Hormone sensitive (ER+ and/or PgR+) patients whose disease has progressed either on or within 1 year of adjuvant therapy, or who has progressed on first line therapy for advanced disease (excluding Arimidex)
- •6. WHO performance status (PS) 0-2 and life expectancy > 12 weeks. Patients with PS 3 will be eligible unless the Investigator believes the poor PS is predominantly due to co-existing morbidity (e.g. severe cardiac impairment)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Treatment within 4 weeks before randomisation and/or whilst on study, treatment with the following: Non-approved or experimental drug; Chemotherapy, radiotherapy or other anticancer therapy
- •2. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
- •3. Previous enrolment or randomisation of treatment in the present study
- •4. Previous definitive radiotherapy (e.g. to chest wall) within 6 weeks before randomisation
- •5. Any unresolved toxicity > CTC grade 2 from previous anticancer therapy
- •6. History of hypersensitivity to active or inactive excipients of ZD6474, placebo or Arimidex
- •7. Major surgery within 4 weeks of randomisation, or incompletely healed surgical incision
- •8. Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix).
- •9. Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable without steroid treatment for 1 week
- •10. Any of the following laboratory values: Total bilirubin > 1.5 x ULRR; ALT or AST > 2.5 x ULRR or > 5 x ULRR if judged by the investigator to be related to liver metastases; Serum creatinine >1.5 x ULRR or creatinine clearance <= 50mL/minute (calculated by Cockcroft-Gault formula)
- •11. Any of the following laboratory values: platelets < 100 x10e9/l; ANC < 1.5 x 10e9/l
- •12. Potassium <4.0mmol despite supplementation; serum calcium (or ionised or adjusted for albumin), or magnesium out of normal range despite supplementation
- •13. Significant cardiac event (e.g.myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association classification of heart disease >=2 within 3 months before entry, or presence of cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.
- •14. History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tacchycardia, symptomatic or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia. Atrial fibrillation, controlled on medication is not excluded.
- •15. Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
- •16. Previous QT prolongation with other medication that required discontinuation of that medication
- •17. Presence of left bundle branch block (LBBB)
- •18. QTc with Bazett’s correction unmeasurable or >= 480msec or greater on screening ECG (Note: if patient has QTc interval >= 480msec on screening ECG, the screen ECG may be repeated twice, at least 24 hours apart. The average QTc from the 3 screening ECGs must be <480msec for the patient to be eligible for the study)
- •19. Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes
- •20. Any severe concomitant condition which, in the Investigator’s opinion, makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the study protocol. e.g. uncontrolled cardiac disease
- •21. Hypertension not controlled by medical therapy (systolic blood pressure >160mmHg or diastolic blood pressure >110mmHg)
- •22. Currently receiving the following drugs that are potent inducers of CYP P450 3A4 - phenytoin, rifampicin, carbamezapine, phenobarbitone and St Johns Wort
研究者
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