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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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7 September 2021 |
Main ID: |
EUCTR2005-003592-20-ES |
Date of registration:
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24/10/2005 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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).
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Scientific title:
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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). |
Date of first enrolment:
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23/12/2005 |
Target sample size:
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65 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2005-003592-20 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Hungary
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Spain
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Sweden
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Cáncer de mama avanzado (CMA)
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Intervention(s)
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Product Name: ZACTIMA Product Code: ZD6474 Pharmaceutical Form: Tablet INN or Proposed INN: vandetanib Current Sponsor code: ZD6474 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): The primary outcome variable is a progression event defined as the earliest of: · Objective disease progression at the data cut-off date (approximately 6 months after the last patient is randomised), as measured using RECIST criteria · Death from any cause
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Main Objective: To assess the efficacy of ZD6474 in combination with docetaxel in the treatment of ABC using the progression event count methodology.
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Secondary Objective: To assess the safety and tolerability of ZD6474 in combination with docetaxel in the treatment of ABC by review of adverse events and laboratory parameters.
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Secondary ID(s)
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2005-003592-20-HU
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D4200C00046
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 30/11/2005
Contact:
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