Overview

Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

Status:
Terminated
Trial end date:
2019-03-06
Target enrollment:
0
Participant gender:
All
Summary
The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Cadexomer iodine
Iodine
Criteria
Inclusion Criteria:

Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph
node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to
receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone
suppression

Exclusion criteria:

Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell
carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved
toxicity ≥ common terminology criteria for adverse event Grade 2