Randomized Double-blind Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Sorafenib Treatment in Patients With Advanced (Recurrent, Persistent and/or Metastasizing) Medullary Thyroid Carcinoma

Eanm Research Ltd1 site in 1 countryOctober 2012

ConditionsMedullary Thyroid Carcinoma

InterventionsSorafenib

DrugsSorafenib

Overview

Phase: Phase 2
Intervention: Sorafenib
Conditions: Medullary Thyroid Carcinoma
Sponsor: Eanm Research Ltd
Locations: 1
Primary Endpoint: Progression Free Survival (PFS)
Status: Withdrawn
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of his study is to evaluate the efficacy and safety of Sorafenib versus placebo in subjects with locally advanced medullary thyroid cancer (MTC). The primary study objective is to compare the Progression-free Survival (PFS) of the Sorafenib treatment group with the placebo treatment group in patients with advanced MTC.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eanm Research Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Inpatient or outpatient ≥ 18 years of age
•Histologically confirmed medullary thyroid carcinoma
•Recurrent or persistent local disease and/or distant metastases
•No more than one prior line of systemic therapy
•Best available supportive care to control (endocrine) symptoms
•At least one defined lesion in CT or MRI evaluable for Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or at least one defined lesion in CT or MRI not evaluable by RECIST in combination with elevated tumour markers
•Progression within previous 12 months
•Hb \> 8g/dl, white blood cells (WBC) \>3.000 cells/mm³ (ANC \> 1.500 cells/mm³), platelets \> 100.000 cells/mm³, bilirubin \< 2mg/dl, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 x upper limit of normal (ULN)
•Performance status: WHO ≤ 2; Karnofsky index ≥ 50%
•Sufficient renal function (creatinin \<1.5 mg/dl and creatinin clearance \> 30ml/min)

Exclusion Criteria

•Unresolved toxicity (i.e. neurotoxicity) attributed to any prior therapy higher than National Cancer Institute-Common Toxicity Criteria for Adverse Effects (NCI-CTCAE version 4) Grade 2 (excluding cases of alopecia)
•Patients with history of allergic or hypersensitivity reaction to study drug or placebo or their excipients
•Current participation in another investigational trial
•Patients with significant cardiovascular disease
•Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin
•Congenital long corrected QT interval (QTc) syndrome, history of drug induced QTc prolongation, or QTc interval unmeasurable or more than 450 ms
•Abnormal serum electrolytes such as potassium, magnesium and calcium
•Uncontrolled hypertension, despite optimal management
•Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization
•Non-healing wound, ulcer, or bone fracture

Arms & Interventions

Sorafenib tablets

Oral administration of Sorafenib tablets, 400 mg bid, until disease progression or unacceptable toxicity

Intervention: Sorafenib

Placebo tablets

Oral administration of Placebo tablets until disease progression, afterwards continuation with Sorafenib at the discretion of the investigator

Intervention: Sorafenib

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

Time Frame: from the date of randomisation until the date of radiological or biochemical progression or death. An average of 9 months is assumed.

The proportion of patients with PFS in the Sorafenib group and the Placebo group will be compared by log rank test and Kaplan-Meier plot.

Secondary Outcomes

Time to Progression (TPP)(from the date of randomisation until the date of confirmed radiological or biochemical progression. An average of 9 months is assumed.)