A study to assess the activity and safety of vandetanib in patients with papillary or follicular thyroid cancer

• Conditions: ocally advanced or metastatic papillary or follicular thyroid carcinoma; MedDRA version: 14.1Level: LLTClassification code 10016935Term: Follicular thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-001890-27-BE
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-07
• Last Update Posted: 2 September 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1.Provision of written informed consent prior to any study-related procedures.
2.Female or male aged 18 years and over.
3.Previously confirmed histological diagnosis of advanced or metastatic papillary or follicular thyroid carcinoma, without anaplastic component. Tumor sample available for centralized exploratory analysis.
4. Presence of a measurable tumour as defined by:

(a) A solitary measurable lesion: For conventional CT scanners, the minimum-sized for the lesion should be =20 mm using effective slice thicknesses = 5mm, or for spiral (helical) CT scanners, the minimum size of solitary lesion at baseline should be = 10 mm using effective slice thicknesses.
(b) For multiple lesions, a sum of diameter 20 mm (with no target lesion measuring < 10 mm using effective slice thicknesses = 5 mm), or for multiple lesions, a sum of diameter > 30 mm (with no target lesion measuring < 15 mm using effective slice thicknesses > 5 mm).
5.Life expectancy of 12 weeks or longer.
6.WHO Performance status 0-2.
7.Able to swallow study medication.
8.Progressive disease following RAI131 or patient unsuitable for RAI131 after surgery.
9. Serum TSH below normal reference range.
10.Negative pregnancy test for female subjects of childbearing 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.Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days.
2.Major surgery within 4 weeks before randomization.
3.Prior chemotherapy within the last 4 weeks prior to randomization.
4.RAI131 therapy within 3 months in patients with radioiodine uptake.
5.Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy).
6.Serum bilirubin >1.5 x the upper limit of reference range (ULRR).
7.Creatinine clearance <30 ml/minute (calculated by Cockcroft-Gault formula).
8.Potassium below normal reference range despite supplementation; or above the CTCAE grade 1 upper limit.
9.Magnesium below the normal range despite supplementation or above the CTCAE grade 1 upper limit.
10.Serum calcium above the CTCAE grade 1 upper limit.
11.In cases where the serum calcium is below the normal range:
-the calcium adjusted for albumin is to be obtained and substituted for the measured serum value. Exclusion is to then be based on the calcium adjusted for albumin values decreasing below the normal limit. Corrected Calcium=Ca + 0.8 X (4-serum albumin)
12.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 × ULRR, or greater than 5.0 × ULRR if judged by the investigator to be related to liver metastases.
13.Clinically significant cardiovascular event (eg myocardial infarction), superior vena cava [SVC] syndrome, New York Heart Association [NYHA] classification of heart failure >II 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 tachycardia, which is symptomatic or requires treatment (CTCAE grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.
15.Congenital long QT syndrome or 1st degree relative with unexplained sudden death under 40 years of age.
16.QT prolongation with other medications that required discontinuation of that medication.
17.Presence of left bundle branch block (LBBB).
18.QTc with Bazett’s correction unmeasurable or >480 msec on screening ECG (Note: If a subject has QTc interval >480 msec on screening ECG, the screen ECG may be repeated 2 times [at least 24 hours apart]. The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study). Patients who are receiving a drug that has a risk of QTc prolongation (see Appendix E for list of medications) are excluded if QTc is = 460 msec.
19.Hypertension not controlled by medical therapy (systolic BP greater than 160 millimeter of mercury [mmHg] or diastolic blood pressure greater than 100 mmHg).
20.Any concomitant medications that may cause QTc prolongation or induce Torsades de Pointes (see Appendix E for the lists of medications in Table 1 & Table 2) or induce CYP3A4 function.
21.Currently active diarrhea that may affect the ability of the patient to absorb the ZACTIMA or tolerate diarrhea.
22.Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal ce

Study & Design

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