Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00984282
• Date of registration: 24/09/2009
• Prospective Registration: Yes
• Primary sponsor: Bayer
• Public title: Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
• Scientific title: A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer
• Date of first enrolment: October 15, 2009
• Target sample size: 417
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00984282
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Austria, Belgium, Bulgaria, China, Denmark, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, United Kingdom, United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular
and Hurthle cell)

- Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are
eligible provided that the histology has no medullary differentiation nor anaplastic
features

- Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors]
should be used as a basis for the assessment of disease progression)

- RAI (radioactive iodine) refractory

Exclusion Criteria:

- Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic
and medullary carcinoma, lymphoma or sarcoma)

- Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies
(licensed or investigational) that target VEGF (vascular endothelial growth factor) or
VEGF Receptors or other targeted agents

- Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose
chemotherapy for radiosensitization is allowed) or Thalidomide or any of its
derivatives



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thyroid Neoplasms

Intervention(s)

Drug: Placebo

Drug: Sorafenib (Nexavar, BAY43-9006)

Primary Outcome(s)

Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation [Time Frame: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years]

Secondary Outcome(s)

Duration of Response (DOR) Based on Central Assessment [Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years]

Disease Control Rate (DCR) Based on Central Assessment [Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years]

AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State) [Time Frame: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)]

Maximum Percent Reduction in Target Lesion Size Based on Central Assessment [Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years]

Response Rate Based on Central Assessment [Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years]

Overall Survival (OS) [Time Frame: From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years]

Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation [Time Frame: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years]

Secondary ID(s)

14295

2009-012007-25

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen

Results

• Results available: Yes
• Date Posted: 10/12/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00984282