Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Medullary Thyroid Carcinoma	Drug: Sorafenib	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Cancer Thyroid Diseases

Drug Information available for: Thyroid Sorafenib Sorafenib tosylate

Genetic and Rare Diseases Information Center resources: Thyroid Cancer, Medullary Carcinoid Tumor Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Eanm Research Ltd:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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 Outcome Measures:

Time to Progression (TPP) [ Time Frame: from the date of randomisation until the date of confirmed radiological or biochemical progression. An average of 9 months is assumed. ] [ Designated as safety issue: No ]
The average TTP in the Sorafenib group and the Placebo group will be compared.

Other Outcome Measures:

Overall Survival (OS) [ Time Frame: from the date of randomisation until the date of death due to any cause. Final assessment at the end of study after approximately 36 months. ] [ Designated as safety issue: No ]
The proportion of surviving patients in the Sorafenib group and the Placebo group will be compared.


Enrollment:	0
Study Start Date:	October 2012
Study Completion Date:	April 2013
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Sorafenib tablets Oral administration of Sorafenib tablets, 400 mg bid, until disease progression or unacceptable toxicity	Drug: Sorafenib
Placebo Comparator: Placebo tablets Oral administration of Placebo tablets until disease progression, afterwards continuation with Sorafenib at the discretion of the investigator	Drug: Sorafenib

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736878

Locations


Germany
University Hospital Ulm, Clinic for Nuclear Medicine
Ulm, Baden-Wuerttemberg, Germany, D-89081

Sponsors and Collaborators

Eanm Research Ltd

More Information


Responsible Party:	Eanm Research Ltd
ClinicalTrials.gov Identifier:	NCT01736878 History of Changes
Other Study ID Numbers:	EARL-2 2011-006250-90
Study First Received:	October 23, 2012
Last Updated:	May 16, 2013
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices Austria : Federal Ministry for Labour, Health, and Social Affairs

Keywords provided by Eanm Research Ltd:


Medullary Thyroid Carcinoma Sorafenib Efficacy

Additional relevant MeSH terms:


Carcinoma Thyroid Diseases Thyroid Neoplasms Carcinoma, Neuroendocrine Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal	Adenocarcinoma Neoplasms, Nerve Tissue Sorafenib Niacinamide Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 27, 2016

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