Overview

This trial is active, not recruiting.

Condition differentiated thyroid cancer
Treatments selumetinib, placebo, radioactive iodine therapy
Phase phase 3
Target MEK
Sponsor AstraZeneca
Start date August 2013
End date November 2017
Trial size 400 participants
Trial identifier NCT01843062, D1532C00065, EudraCT 2013-000423-14

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Selumetinib plus Radioactive Iodine Therapy
selumetinib
3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period
radioactive iodine therapy
A single oral radioactive iodine dose of 100 mCI(3.7 GBq) 131I (+/-10% at the time of administration)to be administered 30 days after randomization. Additionaly, Thyrogen (Recombinant human TSH) will be used to stimulate iodine uptake according to the manufacturer's recommendation(0.9 mg intramuscular injection once a day for the 2 days prior to the dose of radioactive iodine)
(Placebo Comparator)
Placebo plus Radioactive Iodine Therapy
placebo
3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period
radioactive iodine therapy
A single oral radioactive iodine dose of 100 mCI(3.7 GBq) 131I (+/-10% at the time of administration)to be administered 30 days after randomization. Additionaly, Thyrogen (Recombinant human TSH) will be used to stimulate iodine uptake according to the manufacturer's recommendation(0.9 mg intramuscular injection once a day for the 2 days prior to the dose of radioactive iodine)

Primary Outcomes

Measure
Complete remission rate in overall study population
time frame: Measured at 18 months post radioactive iodine treatment

Secondary Outcomes

Measure
Clinical remission rate in overall study population
time frame: Measured at 18 months post radioactive iodine treatment
Clinical remission rate in sub-group of patients with tumours known to be mutation positive for v-raf murine sarcoma viral oncogene homolog B1 or NRAS
time frame: Measured at 18 months post radioactive iodine treatment
Frequency of adverse events graded according to the National Cancer Institute Common Terminology Criteria for AEs (CTCAE)"
time frame: Measured throughout the study until 3 years post radioactive iodine treatment
Selumetinib concentration profile over time
time frame: In total 8 blood samples will be collected: 4 samples on pre defined time windows on Day1, and 4 samples on Day 29 or Day 30
N-desmethyl selumetinib concentration profile over time
time frame: in total 8 blood samples will be collected: 4 samples on pre defined time windows on Day1, and 4 samples on Day 29 or Day 30
Selumetinib amide concentration profile over time
time frame: in total 8 blood samples will be collected: 4 samples on pre defined time windows on Day1, and 4 samples on Day 29 or Day 30
Complete remission rate in sub-group of patients with tumours known to be mutation positive for v-raf murine sarcoma viral oncogene homolog B1 or NRAS
time frame: Measured at 18 months post radioactive iodine treatment

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

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

Additional Information

Official title 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
Principal investigator Alan Ho, M.D., PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.