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

AstraZeneca

Status and phase: Terminated; Phase 3

Conditions: Differentiated Thyroid Cancer

Treatments: Drug: Placebo; Drug: Radioactive Iodine Therapy; Drug: Selumetinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT01843062

2013-000423-14 (EudraCT Number)

D1532C00065

Details and patient eligibility

About

The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

Full description

A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer.

Enrollment: 233 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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233 participants in 2 patient groups, including a placebo group

Selumetinib

Experimental group

Description:

Selumetinib plus Radioactive Iodine Therapy

Treatment:

Drug: Radioactive Iodine Therapy

Drug: Selumetinib

Placebo

Placebo Comparator group

Description:

Placebo plus Radioactive Iodine Therapy

Treatment:

Drug: Radioactive Iodine Therapy

Drug: Placebo