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

Differentiated Thyroid Cancer Clinical Trial

— ASTRA  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01843062
• Other study ID #: D1532C00065
• Secondary ID: 2013-000423-14
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Differentiated Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

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

External Links

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