Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma

NCT ID: NCT01736878

Last Updated: 2013-05-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-04-30

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.

Conditions

Medullary Thyroid Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sorafenib tablets

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

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

Placebo tablets

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

Group Type: PLACEBO_COMPARATOR

Sorafenib

Intervention Type: DRUG

Interventions

Sorafenib

Intervention Type: DRUG

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)
• International normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
• No acute infections
• Staging studies (MRT or CT and Calcitonin or CEA) completed within four weeks of protocol randomisation
• Women of childbearing potential with negative serum pregnancy test
• Women and men of childbearing potential using adequate contraception
• Signed and dated written informed consent

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
• Evidence or history of bleeding diathesis or coagulopathy disorder
• Hemorrhage/bleeding event ≥ Grade 3
• Thrombotic or embolic events including transient ischemic attacks within the past 6 months
• Subjects with symptomatic brain metastases or Subjects with brain metastases under corticosteroid treatment
• Pregnant or breast-feeding patients
• Patients with uncontrolled infections
• Known HIV infection or infection with hepatitis B or C
• Immunosuppression
• Subjects with seizure disorder requiring medication • Subjects undergoing renal dialysis
• Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results
• Any malabsorption condition

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eanm Research Ltd

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Ulm, Clinic for Nuclear Medicine

Ulm, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

2011-006250-90

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EARL-2

Identifier Type: -

Identifier Source: org_study_id