Efficacy and Safety Study of Sorafenib to Treat Advanced Medullary Thyroid Carcinoma (SUMMIT)
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|ClinicalTrials.gov Identifier: NCT01736878|
Recruitment Status : Withdrawn (Study was withdrawn due to unanticipated hassle in patient recruitment.)
First Posted : November 29, 2012
Last Update Posted : May 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Medullary Thyroid Carcinoma||Drug: Sorafenib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: Sorafenib tablets
Oral administration of Sorafenib tablets, 400 mg bid, until disease progression or unacceptable toxicity
Placebo Comparator: Placebo tablets
Oral administration of Placebo tablets until disease progression, afterwards continuation with Sorafenib at the discretion of the investigator
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736878
|University Hospital Ulm, Clinic for Nuclear Medicine|
|Ulm, Baden-Wuerttemberg, Germany, D-89081|