A Phase II study to investigate the effect of Glivec® (imatinib mesylate, formerly known as STI571) in patients with inoperable medullary thyroid carcinoma.
- Conditions
- Medullary thyroid carcinoma: progressive diseasephase-2 study, open label.
- Registration Number
- NL-OMON21527
- Lead Sponsor
- /A
- Brief Summary
de Groot JW, Zonnenberg BA, van Ufford-Mannesse PQ, de Vries MM, Links TP, Lips CJ, Voest EE.A phase II trial of imatinib therapy for metastatic medullary thyroid carcinoma.J Clin Endocrinol Metab. 2007 Sep;92(9):3466-9.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Patients „d 18 years of age;
2. The subject has advanced histologically proven medullary thyroid cancer. Advanced disease is defined as locally recurrent disease or metastatic disease that is not amenable to curative resection. The subject must have measurable disease;
1. The subject is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if the other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ;
2. The subject with known brain metastases;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to determine the objective response rate (partial and complete responses) in subjects with advanced medullary thyroid carcinoma.
- Secondary Outcome Measures
Name Time Method 1. To determine the time to tumor progression;<br /><br>2. To evaluate overall survival; <br /><br>3. To evaluate the safety profile of Glivec in advanced medullary thyroid carcinoma.