ot aplicable

Active, not recruiting

• Conditions: medullary thyroid cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2006-001354-28-NL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04-20
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1.Provision of written informed consent
2.Female or male aged 18 years and over
3.Previously confirmed histological diagnosis of locally advanced or metastatic hereditary medullary thyroid carcinoma without standard therapeutic options for treatment. Documentation must be provided in the subject’s medical chart.
4.Life expectancy of 12 weeks or longer
5.WHO Performance status 0-2
6.One or more measurable lesions at least 10 mm in the longest diameter by spiral CT scan (5 mm slice thickness) or 20 mm with conventional techniques (>5 mm slice thickness) according to modified RECIST criteria
7.Negative pregnancy test for women of childbearing potential. Female subjects must be one year postmenopausal, surgically sterile, or using an acceptable method of contraception. Male subjects must be surgically sterile or using an acceptable method of contraception during their participation in this study
8. Able to swallow study medication as a whole tablet. Tablets should not be chewed, crushed or divided.
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 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1.Brain metastases or spinal cord compression, unless irradiated at least 4 weeks before first dose and stable without steroid treatment for = 1 week
2.The last dose of prior chemotherapy is received less than 4 weeks before the start of study therapy
3.Radiation therapy within the last 4 weeks before the start of study therapy.
4.Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
5.Any unresolved toxicity greater than CTCAE grade 2 from previous anti-cancer therapy
6.Serum bilirubin greater than 1.5 x ULRR
7.Serum creatinine greater than 1.5 x ULRR or creatinine clearance =50 ml/min (calculated by Cockcroft-Gault formula)
8.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) > 2.5 x ULRR if no demonstrable liver mets, or > 5 x ULRR if judged by the Investigator to be related to liver metastases
9.Significant cardiac event (eg. myocardial infarction, super vena cava [SVC] syndrome, New York Heart Association [NYHA] 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
10.History of arrhythmia (multifocal premature ventricular contractions (PVC’s), bigeminy, trigeminy, ventricular tachycardia, symptomatic or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
11.Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age
12.QT prolongation with other medications that required discontinuation of that medication
13.Presence of left bundle branch block (LBBB)
14.QTc with Bazett’s correction unmeasurable or = 480 msec or greater on screening ECG. (Note: If a subject has QTc =480 msec on screening ECG, the screen ECG may be repeated twice). One ECG, or the mean, if more than one are performed, must have a QTc value of <480 msec in order for the patient to be eligible for the study.
15.Potassium <4.0 mmol/L despite supplementation; serum calcium (or ionized or adjusted for albumin), or magnesium out of normal range despite supplementation
16.Pregnancy or breast feeding (women of child-bearing potential)
17.Any concomitant medications that may affect QTc or induce CYP3A4 function (with the exception of somatostatin or somatostatin analog) and / or prohibited medications referenced in Appendix E and Section 3.8 of the clinical study protocol
18.HTN not controlled by medical therapy (systolic blood pressure greater than 160 millimeter of mercury [mmHg] or diastolic blood pressure greater than 100 mmHg)
19.Previous or current malignancies at other sites within last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell or squamous cell carcinoma of the skin
20.Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator’s opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol
21.Previous enrollment in the present study or previous enrollment on study with treatment using ZD6474
22.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
23.Receipt of any

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified