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

May 16, 2013 updated by: Eanm Research Ltd

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The average TTP in the Sorafenib group and the Placebo group will be compared.
from the date of randomisation until the date of confirmed radiological or biochemical progression. An average of 9 months is assumed.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The proportion of surviving patients in the Sorafenib group and the Placebo group will be compared.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eanm Research Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

November 26, 2012

First Posted (Estimate)

November 29, 2012

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 16, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EARL-2
  • 2011-006250-90 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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