Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02021942|
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : February 2, 2018
Last Update Posted : February 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Primary Inoperable Thymoma Local Recurrent Thymoma||Drug: SOM230 LAR||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
Experimental: SOM230 LAR
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Drug: SOM230 LAR
SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.
- Percent Change in Tumor Volume From Baseline to EOS [ Time Frame: at least 6 months ]To evaluate whether SOM230 LAR is effective in patients with inoperable thymoma with respect to shrinkage of tumor volume. Response is defined as the decrease in tumor volume of 20 % at EOS as compared to baseline. Tumor shrinkage is assessed by CT or MRI.
- Tumor Resection Status [ Time Frame: at least 6 months ]
To evaluate the resection status based on the categories R0, R1 and ≥ R2 at EOS using CT or MRI imaging.
R0 resection means no residual tumor tissue (best status); R1 indicates microscopic residual tumor tissue and R2 indicates macroscopic residual tumor tissue (worst status).
- Assessment of Tumor Operability [ Time Frame: at least 6 months ]Assessment if patients reaching operability at the EOS.
- Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: at least 6 months ]
- Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status [ Time Frame: at least 6 months ]MG severity status is assessed by determining Titin-antibody status at Baseline and EOS.
- Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations [ Time Frame: at least 6 months ]MG severity status is assessed by measuring ACHR-antibody concentrations at Baseline and EOS.
- Health Related Quality of Life [ Time Frame: at least 6 months ]
Health related quality of life information was collected at Baseline and EOS using SF-36 questionnaire. Questionnaires had to be completed by the patients. All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible.
Patient reported answers were transformed into domain scores according to the guidelines provided by RAND/MOS. Statistical significance of the result was tested with a paired Wilcoxon rang sum test with a significance level of 0.05 considering only paired values (n=11) using PSPP Version 0.10.1.
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): NCT02021942
|Klinik und Poliklinik für Neurologie der Universität Regensburg|
|Regensburg, Bavaria, Germany, 93053|
|Principal Investigator:||Berthold Schalke, Prof. Dr.||Professor|