E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Follow-up of Thyroid Cancer Patients from Study THYR-008-00 |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10043738 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To confirm the status of thyroid remnant ablation by using Thyrogen-stimulated radioiodine static neck imaging in patients previously treated in the THYR-008-00 study. |
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E.2.2 | Secondary objectives of the trial |
To learn if there was recurrence of thyroid cancer in any of the patients previously treated in the THYR-008-00 study. To assess Thyrogen-stimulated serum thyroglobulin Tg measurements in patients previously treated in the THYR-008-00 study. To assess safety information on repeat exposure to Thyrogen in patients previously treated in the THYR-008-00 study |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Committed to follow the protocol requirements, as evidenced by providing written informed consent before any study-related procedures are performed and within 28 days prior to Day 1; 2. Completed the THYR-008-00 study; 3. A negative serum pregnancy test within 8 days prior to the start of the week during which the patient will receive Thyrogen and radioiodine required for all pre-menopausal women of child bearing potential, with menopause defined as age 50 years with 2 years without a menstrual period . |
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E.4 | Principal exclusion criteria |
1. Patients who are currently taking amiodarone or other prescribed iodine-containing medication; 2. Patients who received iodine-containing X-ray contrast material within the prior 3 months; 3. Women of child-bearing potential, unless confirmed to have a negative pregnancy test prior to dosing; 4. Women who are pregnant or lactating; 5. Patients who are currently participating in another investigational drug study or who have participated in such a study within 30 days of their enrollment in this study; 6. Patients who are unwilling or unable to complete all the required study procedures per protocol with the exception of patients for whom scanning could pose a medical risk ; 7. The patient who by mistake received only one-half the intended dose of Thyrogen during THYR-008-00 Patient 209 ; 8. The patient in THYR-008-00 who was found to have lung metastases on her post therapy scan Patient 204 ; 9. A concurrent major medical disorder e.g., documented significant cardiac disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver disease, advanced pulmonary disease, or advanced cerebral vascular disorder that may have an impact on the capability of the patient to adequately comply with the requirements of this study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To confirm the status of thyroid remnant ablation by using Thyrogen-stimulated radioiodine static neck imaging in patients previously treated in the THYR-008-00 study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 3 |