EUCTR2010-023428-26-IT进行中（未招募）不适用
A Randomized, International, Open-Label, Multi-Centre, Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients with Locally Advanced or Metastatic Medullary Thyroid Cancer Experience Grade 2 or Higher Adverse Events during the First 12 Months of Treatment with Vandetanib - ND
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Provision of informed consent prior to any study specific procedures
- •2.Female or male aged 18 years and over
- •3.Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient’s medical chart.
- •4.WHO or ECOG Performance status 0-2
- •5.Negative pregnancy test (urine or serum) for female patients 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
- •1.Provision of informed consent prior to any study specific procedures
- •2.Female or male aged 18 years and over
- •3.Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient’s medical chart.
- •4.WHO or ECOG Performance status 0-2
- •5.Negative pregnancy test (urine or serum) for female patients 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
排除标准
- •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.The last dose of prior chemotherapy received less than 3 weeks prior to randomization
- •4.Radiation therapy not completed prior to the first dose of vandetanib
- •5.Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy (this criterion does not apply to alopecia)
- •6.Serum bilirubin greater than 1.5 x the upper limit of reference range (ULRR), this criterion does not apply to patients with Gilbert’s Disease
- •7.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 x ULRR, or greater than 5.0 x ULRR if judged by the investigator to be related to liver metastases
- •8.Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula, reference in Appendix G)
- •9.Potassium <4.0 mmol/L despite supplementation, or above the CTCAE grade 1 upper limit. Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit. Calcium can be evaluated by either ionized or standard serum tests. Ionized calcium values below the normal range or above the CTCAE grade 1 upper limit. If serum calcium is used, exclusion for values above the CTCAE grade 1 upper limit. 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 falling below the normal limit. Corrected Calcium=Ca + 0.8 X (4-serum albumin)
- •10.Significant cardiac event (eg myocardial infarction), superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease =2 (reference Appendix H), within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
- •11.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. Patients with atrial fibrillation controlled by medication are permitted.
- •12.Congenital long QT syndrome
- •13.Any concomitant medications that are known to be associated with Torsades de Pointes (reference Appendix E, Table 1) or potent inducers of CYP3A4 function and/or any prohibited medications referenced in Section 5.6
- •14.History of QT prolongation associated with other medications that required discontinuation of that medication
- •15.QTc with Bazett’s correction unmeasurable or =480 ms on screening ECG (Note: If a patient has QTc interval =480 ms on screening ECG, the screening ECG may be repeated 2 times [at least 24 hours apart] for a total of 3 ECGs. The average QTc from the three screening ECGs must be <480 ms in order for the patient to be eligible for the study).
- •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.The last dose of prior chemotherapy received less than 3 weeks prior to randomization
- •4.Radiation therapy not completed prior to the first dose of vandetanib
- •5.Any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy (this criterion does not apply to alopecia)
- •6.Serum bilirubin greater than 1.5 x the upper limit of reference range (ULRR), this criterion does not apply to patients with Gilbert’s Disease
- •7.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 x ULRR, or greater than 5.0 x ULRR if judged by the investigator to be related to liver metastases
- •8.Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula, reference in Appendix G)
- •9.Potassium <4.0 mmol/L despite supplementation, or above the CTCAE grade 1 upper limit. Magnesium below the normal range despite supplementation, or above the CTCAE grade 1 upper limit. Calcium can be evaluated by either ionized or standard serum tests. Ionized calcium values below the normal range or above the CTCAE grade 1 upper limit. If serum calcium is used, exclusion for values above the CTCAE grade 1 upper limit. 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 falling below the normal limit. Corrected Calcium=Ca + 0.8 X (4-serum albumin)
- •10.Significant cardiac event (eg myocardial infarction), superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease =2 (reference Appendix H), within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia
- •11.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. Patients with atrial fibrillation controlled by medication are permitted.
- •12.Congenital long QT syndrome
- •13.Any concomitant medications that are known to be associated with Torsades de Pointes (reference Appendix E, Table 1) or potent inducers of CYP3A4 function and/or any prohibited medications referenced in Section 5.6
- •14.History of QT prolongation associated with other medications that required discontinuation of that medication
- •15.QTc with Bazett’s correction unmeasurable or =480 ms on screening ECG (Note: If a patient has QTc interval =480 ms on screening ECG, the screening ECG may be repeated 2 times [at least 24 hours apart] for a total of 3 ECGs. The average QTc from the three screening ECGs must be <480 ms in order for the patient to be eligible for the study).
研究者
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