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

This study has been withdrawn prior to enrollment.
(Study was withdrawn due to unanticipated hassle in patient recruitment.)
Sponsor:
Information provided by (Responsible Party):
Eanm Research Ltd
ClinicalTrials.gov Identifier:
NCT01736878
First received: October 23, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  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:

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
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

No publications provided

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:
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Thyroid Diseases
 Sorafenib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015