A Pilot Study in Metastatic Advanced Thyroid Cancer Evaluating the Safety and Efficacy of Sorafenib - MATiSSe
- Conditions
- Patients with localled advanced or metastatic thyroid cancer . histological sub-types will include differentiated and medullary thyroid cancer.
- Registration Number
- EUCTR2006-006615-80-GB
- Lead Sponsor
- Royal Marsden Nhs Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 33
1. Human subjects with advanced / metastatic differentiated or medullary thyroid carcinoma
2. Patients must have one of the following histological sub-types
- Any papillary subtypes including follicular variants, tall cell, columnar cell and diffuse sclerosing,
- Any follicular, hurthle cell or medullary
3. Patients must be deemed not suitable for radio active iodine therapy
4. Must have uni-dimensional measurable disease on CT or MRI according to Response Evaluation Criteria of Solid tumours (RECIST)
5. Lesions which are accessible for low risk biopsy
6. Male/female subjects age 18 years or greater
7. Patients with ECOG performance status 0, 1 see appendix 3
8. Life expectancy greater than 12 weeks
9. The cognitive capacity to understand patient information sheets and give written informed consent and be able to comply with follow up requirements
10. Women must be post-menopausal (no menstrual period for at least a year) or have a negative pregnancy serum test on entry into the study (even if surgically sterilized)
Patients must refrain from becoming pregnant throughout their treatment and for upto 6 months after stopping study drug. They must be on adequate contraception (abstinence, oral contraceptives, barrier method with spermicide, implantable or injectable contraceptive or surgical sterilization) throughout this period.
Patients must have adequate renal, liver and haematological function
11 Serum creatinine = 1.5 x ULN
12. Serum aspartate transaminase and alanine transaminase = 2.5 x ULN
13. Total serum bilirubin = 1.5 x ULN
14. Amylase and lipase < 1.5 x ULN
15. Haemoglobin = 9.0g/dl
16. Absolute neutrophil count = 1.5 x 109 mm3
17. Platelets = 100 x 109/L
18. Prothombin time = 1.5 x ULN
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
A patient will not be eligible for inclusion in this study if any of the following apply
1. Anaplastic and poorly differentiated carcinoma of the thyroid
2. Previous malignancy except cervical cis, Basal cell carcinoma or superficial bladder cancer
3. Patients with recent or active bleeding diathesis
4. HIV infection or chronic Hepatitis B or C
5. Concomitant rifampicin and Hypericum perforatum also known as St. John’s wort
6. Patients with congestive heart failure greater than NYHA functional class II (symptomatic during ordinary activity; (see Appendix 5)
7. Patients with cardiac arrhythmias greater than Grade 1 NCI CTCAE, Version 3.0 (see appendix 2) (conduction abnormality and supraventricular arrhythmia present but patient is asymptomatic, intervention not indicated, palpitations present and QTc > 0.45-0.47 second).
8. Patients with active coronary artery disease or ischemia.
9. Patients with Child-Pugh class C hepatic impairment (see appendix 4)
10. Patients with severe renal impairment (calculated creatinine clearance of < 30 ml/min) or who require dialysis.
11. Patients with uncontrolled hypertension or hypertension treated with 2 or more anti-hypertensive agents
12. Intracranial disease, unless there has been radiological evidence of stable intracranial disease > 6 months. In the case of a solitary brain metastasis, evidence of a disease-free interval of at least 3 months post surgery. All patients previously treated for brain metastases must be stable off corticosteroid therapy for at least 28 days
13. Previous treatment with a tyrosine kinase inhbitor or anti-angiogenic agent (licensed or investigational) such as sunitinib or bevacizumab
14. Any drug (licensed or investigational) that targets the RAS, VEGF, VEGFR or EGFR pathway
15. Significant surgery within 4 weeks of start of study
16. Investigational drug therapy during or within 30 days
17. Any cancer chemotherapy, immunotherapy, radiotherapy or hormonal treatment over the last 4 weeks. Palliative radiotherapy to symptomatic disease sites is permitted
Concurrent anti-cancer chemotherapy, immunotherapy or hormonal therapy except biphosphanates
18. Women who are pregnant, breast feeding, or planning pregnancy within 6 months after the last treatment (this includes men who plan to father a child within 6 months of the last treatment)
19. History of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
20. Recent thromboembolic events including MI
21. Need for anti-coagulant therapy (except low dose aspirin)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method