Phase 3 N=417 Randomized Quadruple-blind Treatment

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

Thyroid Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT00984282 ↗

Enrolled (actual)

417

Serious AEs

44.0%

Results posted

Dec 2013

Primary outcome: Primary: Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation — 329; 175 Days — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Sorafenib (Nexavar, BAY43-9006) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bayer
Primary completion: Aug 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-free Survival (PFS) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation	329; 175	<0.0001 sig
SECONDARY Overall Survival (OS)	52.7; 54.8	0.2892
SECONDARY Time to Progression (TTP) Based on Central Assessment Incl. Clinical Progression Due to Bone Irradiation	337; 175	<0.0001 sig
SECONDARY Disease Control Rate (DCR) Based on Central Assessment	86.2; 74.6	0.0015 sig
SECONDARY Response Rate Based on Central Assessment	12.24; 0.5	<0.0001 sig
SECONDARY Duration of Response (DOR) Based on Central Assessment	309; NA	—
SECONDARY Maximum Percent Reduction in Target Lesion Size Based on Central Assessment	17.3; 1.0; 15.3; 1.5; 22.4; 3.5	—
SECONDARY AUC(0-12h),ss (Area Under the Concentration Time Curve From Time 0 to 12 Hours at Steady State)	75.4	—

Summary

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00984282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.