A Phase II, open-label study to assess the efficacy and tolerability of ZD6474 ZACTIMA 100 mg monotherapy in subjects with locally advanced or metastatic hereditary medullary thyroid cancer - ND

• Conditions: ocally advanced or metastatic hereditary medullary thyroid cancer; MedDRA version: 9.1Level: LLTClassification code 10027105Term: Medullary thyroid cancer

• Registration Number: EUCTR2006-001354-28-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04-13
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot 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
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.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 8804;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 8805;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 8805; 480 msec or greater on screening ECG. Note If a subject has QTc 8805;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 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

Study & Design

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