Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Differentiated Thyroid Cancer	Drug: Selumetinib Drug: Placebo Drug: Radioactive Iodine Therapy	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Cancer Thyroid Diseases

Drug Information available for: Iodine Thyroid

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Complete remission rate in overall study population [ Time Frame: Measured at 18 months post radioactive iodine treatment ]

Secondary Outcome Measures:

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 ]


Enrollment:	233
Actual Study Start Date:	August 27, 2013
Estimated Study Completion Date:	July 5, 2019
Estimated Primary Completion Date:	January 8, 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Selumetinib Selumetinib plus Radioactive Iodine Therapy	Drug: Selumetinib 3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period Drug: 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 Placebo plus Radioactive Iodine Therapy	Drug: Placebo 3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period Drug: 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)

Arms

Assigned Interventions

Experimental: Selumetinib

Selumetinib plus Radioactive Iodine Therapy

Drug: Selumetinib

3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period

Drug: 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

Placebo plus Radioactive Iodine Therapy

Drug: Placebo

3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period

Drug: 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)

Detailed 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.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	18 Years to 130 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01843062

Show 45 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Alan Ho, M.D., PHD	Memorial Sloan Kettering Cancer Centre, 1275 York Avenue, New York, NY 10065.
Study Director:	Gabriella Mariani, M.D., PHD	11G34,Mereside,Alderley Park,Macclesfield, Cheshire, England

More Information


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01843062 History of Changes
Other Study ID Numbers:	D1532C00065 EudraCT 2013-000423-14
First Submitted:	March 14, 2013
First Posted:	April 30, 2013
Last Update Posted:	August 3, 2017
Last Verified:	July 2017

Keywords provided by AstraZeneca:


Selumetinib, Differentiated Thyroid Cancer , AZD6244

Additional relevant MeSH terms:


Thyroid Diseases Thyroid Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Iodine	Cadexomer iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs

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