Ensayo en fase II, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de ZD6474 en combinación con docetaxel (Taxotereâ) frente a docetaxel solo como tratamiento de segunda línea del cáncer de mama avanzado (CMA).
- Conditions
- Cáncer de mama avanzado (CMA)
- Registration Number
- EUCTR2005-003592-20-ES
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 65
1. Provision of informed consent
2. Female patients aged 18 years or older
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. Patients should have immunohistochemistry confirmed receptor negative breast cancer or patients who have failed hormonal treatment and who are only eligible for cytotoxic therapy
6. Patients who have failed either on or within 1 year of adjuvant therapy (excluding taxanes), or who have progressed on first line therapy for advanced disease (excluding taxanes)
7. WHO performance status (PS) 0 to2 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)
8. Negative pregnancy test for women of child-bearing potential
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
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 > Common Toxicity Criteria (CTC) grade 2 from previous anticancer therapy
6. History of hypersensitivity to active or inactive excipients of ZD6474, placebo or docetaxel
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: Serum bilirubin greater than the upper limit of reference range (ULRR); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 x ULRR or alkaline phosphatase greater than 2.5 ULRR; Serum creatinine >1.5 x ULRR or creatinine clearance < or =50mL/minute (calculated by Cockcroft-Gault formula)
11. Any of the following laboratory values: platelets <100x10e9/L; absolute neutrophil count (ANC) <1.5 x 10e9/L
12. Potassium <4.0 mmol 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 syndrome, New York Heart Association classification of heart disease > or =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, bigeminy, trigeminy, ventricular tachycardia, 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
18. QTc with Bazett’s correction unmeasurable or > or =480msec or greater on screening ECG (Note: if patient has QTc interval >or =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 (as defined in the protocol)
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 jeopardise compliance with the study protocol e.g. uncontrolled cardiac disease
21. Hypertension not controlled by medical therapy (systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg)
22. Currently rec
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method