Study comparing complete remission after treatment with selumetinb/palcebo in patients with differentiated thyroid cancer

Phase 1

• Conditions: Differentiated Thyroid Cancer; MedDRA version: 20.1 Level: LLT Classification code 10027485 Term: Metastatic thyroid cancer scintigraphy System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000423-14-DK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-08-02
• Study Completion: 2019-03-06
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 233

Inclusion Criteria

Confirmed follicular cell derived differentiated thyroid cancer
Post-surgery staging categories: primary tumor 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 suppression
Patients must have all of the post-operative assessments (including neck US exam,
neck MRI with contrast, and chest CT without contrast) performed no
sooner than 4 weeks post-surgery and the results from each must verify the absence of macroscopic disease.
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

Exclusion Criteria

Known distant metastatic disease at study entry
Diagnosis of anaplastic thyroid cancer, medullary 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
Hypersensitivity to rhTSH and unwillingness to use rhTSH prior to RAT treatment
Previous treatment with any MEK or BRAF inhibitor

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified