Study comparing complete remission after treatment with selumetinb/palcebo in patients with differentiated thyroid cancer
- Conditions
- Differentiated Thyroid CancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2013-000423-14-FR
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 233
Confirmed follicular cell derived differentiated thyroid cancer
Post-surgery staging categories: primary tumour greater than 4 cm or gross extrathyroidal extension (T4 disease) or at least 1 lymph node that is 1 cm or larger or 5 or more involved lymph nodes (of any size)
Previous one or two stage total thyroidectomy with therapeutic neck dissection of metastatic lymph nodes
Patient must be suitable for radioactive iodine therapy
Patient must be suitable for TSH suppresion
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 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
Known distant metastatic disease at study entry
Diagnosis of anaplastic thyroid cancer, modullary thyroid cancer or Hurthle cell carcinoma
Presence of anti-Tg antibodies at screening
Previous treatment with 131 I (RAI) or external beam radiation therapy (EBRT)
Unresolved toxicity = CTCAE Grade 2 from any previous therapy
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