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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01843062
Other study ID # D1532C00065
Secondary ID 2013-000423-14
Status Terminated
Phase Phase 3
First received
Last updated
Start date August 27, 2013
Est. completion date March 6, 2019

Study information

Verified date August 2019
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 233
Est. completion date March 6, 2019
Est. primary completion date May 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 130 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Brazil Research Site Barretos
Brazil Research Site Porto Alegre
Brazil Research Site Ribeirão Preto
Brazil Research Site Rio de Janeiro
Brazil Research Site São José do Rio Preto
Brazil Research Site São Paulo
Denmark Research Site Odense C
France Research Site Angers Cedex 01
France Research Site Bordeaux Cedex
France Research Site Caen Cedex 5
France Research Site Lyon
France Research Site Toulouse Cedex 9
France Research Site Villejuif Cedex
Germany Research Site Augsburg
Germany Research Site Essen
Germany Research Site Leipzig
Italy Research Site Catania
Italy Research Site Napoli
Italy Research Site Pisa
Italy Research Site Roma
Poland Research Site Gliwice
Poland Research Site Kielce
Poland Research Site Poznan
Poland Research Site Warszawa
Poland Research Site Warszawa
Poland Research Site Zgierz
Sweden Research Site Göteborg
Sweden Research Site Linköping
Sweden Research Site Lund
Sweden Research Site Stockholm
United States Research Site Aurora Colorado
United States Research Site Birmingham Alabama
United States Research Site Boston Massachusetts
United States Research Site Boston Massachusetts
United States Research Site Cincinnati Ohio
United States Research Site Durham North Carolina
United States Research Site Little Rock Arkansas
United States Research Site Los Angeles California
United States Research Site Nashville Tennessee
United States Research Site New York New York
United States Research Site New York New York
United States Research Site Philadelphia Pennsylvania
United States Research Site Portland Oregon
United States Research Site Torrance California
United States Research Site Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Brazil,  Denmark,  France,  Germany,  Italy,  Poland,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set Patients were defined to be in complete remission if all of the following criteria were demonstrated:
Serum thyroglobulin (Tg) levels <1 nanograms / millilitre (ng/mL) during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.
No histopathological evidence of thyroid cancer on fine needle aspiration (FNA)/biopsy when performed, as assessed by investigator site review.
No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment
Secondary Complete Remission Rate (Expressed as Percentage of Patients in Complete Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive Patients were defined to be in complete remission if all of the following criteria were demonstrated:
Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
No confirmed radiological evidence of thyroid cancer, as assessed by blinded independent central review.
No histopathological evidence of thyroid cancer FNA/biopsy when performed, as assessed by investigator site review.
No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment
Secondary Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; ITT Analysis Set Patients were defined to be in clinical remission if all of the following criteria were demonstrated:
Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
No evidence of thyroid cancer on diagnostic whole body scan (WBS), as assessed by blinded independent central review.
No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.
No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment
Secondary Clinical Remission Rate (Expressed as Percentage of Patients in Clinical Remission) at 18 Months Post-RAI Treatment; Subgroup Analysis BRAF/NRAS Mutation Positive Patients were defined to be in clinical remission if all of the following criteria were demonstrated:
Serum Tg levels <1 ng/mL during rhTSH stimulation, in the absence of interfering Tg antibodies, as assessed by standardised central laboratory analysis.
No confirmed evidence of thyroid cancer on neck ultrasound, as assessed by investigator site review.
No evidence of thyroid cancer on diagnostic WBS, as assessed by blinded independent central review.
No histopathological evidence of thyroid cancer on FNA/biopsy when performed to clarify equivocal ultrasound findings, as assessed by investigator site review.
No further thyroid cancer therapy was administered in the first 18 months following the initial RAI treatment.
At 18 months post-RAI treatment
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