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Trial record 3 of 4 for:    "Thymoma" | "Octreotide"

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
Sponsor:
Collaborator:
Crolll Gmbh
Information provided by (Responsible Party):
Prof. Dr. Berthold Schalke, University of Regensburg

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Inoperable Thymoma
Local Recurrent Thymoma
Intervention Drug: SOM230 LAR
Enrollment 16
Recruitment Details This monocentric trial was conducted in Regensburg, Germany. The patients were asked for study participation by the investigator.
Pre-assignment Details  
Arm/Group Title SOM230 LAR
Hide Arm/Group Description SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title SOM230 LAR
Hide Arm/Group Description SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
52.6  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
7
  43.8%
Male
9
  56.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Germany Number Analyzed 16 participants
16
 100.0%
1.Primary Outcome
Title Percent Change in Tumor Volume From Baseline to EOS
Hide Description 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.
Time Frame at least 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Initial diagnosis of thymoma for one patient could not be confirmed, but a squamous cell carcinoma was diagnosed by the central pathologist. Tumor voume was 320.99 cm^3 at screening. Tumor size was reduced to 176.87 cm^3 at month 2 (-44.9 % compared to baseline). At month 4 (EOS) tumor volume was slightly increased compared to month 2 (189 cm^3).
Arm/Group Title SOM230 LAR
Hide Arm/Group Description:
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Participants Analyzed 16
Mean (95% Confidence Interval)
Unit of Measure: percentage of tumor volume
-37.38
(-60.88 to -13.88)
2.Secondary Outcome
Title Tumor Resection Status
Hide Description

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).

Time Frame at least 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOM230 LAR
Hide Arm/Group Description:
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Surgery performed with resection status R0
6
  37.5%
Surgery performed with resection status R1
4
  25.0%
No surgery performed
6
  37.5%
3.Secondary Outcome
Title Assessment of Tumor Operability
Hide Description Assessment if patients reaching operability at the EOS.
Time Frame at least 6 months
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Hide Analysis Population Description

Operability of the tumor at the EOS was based on the decision of the treating surgeon. In addition the response criteria had to be fulfilled.

The tumors of 11 patients (68.75%) were operable. One of these patients decided not to undergo surgery. Tumors of 5 patients were inoperable (31.25%) at the EOS.

Arm/Group Title SOM230 LAR
Hide Arm/Group Description:
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Tumor assesed as operable.
11
  68.8%
Tumor assesed as not operable.
5
  31.3%
4.Other Pre-specified Outcome
Title Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Hide Description [Not Specified]
Time Frame at least 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOM230 LAR
Hide Arm/Group Description:
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Number of participants with AEs
16
 100.0%
Number of participants with SAEs
7
  43.8%
5.Other Pre-specified Outcome
Title Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status
Hide Description MG severity status is assessed by determining Titin-antibody status at Baseline and EOS.
Time Frame at least 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOM230 LAR
Hide Arm/Group Description:
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Missing data at baseline or EOS
8
  50.0%
Change from negative to negative
4
  25.0%
Change from negative to positive
0
   0.0%
Change from positive to positive
2
  12.5%
Change from positive to negative
2
  12.5%
6.Other Pre-specified Outcome
Title Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations
Hide Description MG severity status is assessed by measuring ACHR-antibody concentrations at Baseline and EOS.
Time Frame at least 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOM230 LAR
Hide Arm/Group Description:
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Participants Analyzed 16
Measure Type: Count of Participants
Unit of Measure: Participants
Missing data at baseline or EOS
8
  50.0%
ACHR-antibody level increased
1
   6.3%
ACHR-antibody level decreased
4
  25.0%
ACHR-antibody level constant
3
  18.8%
7.Other Pre-specified Outcome
Title Health Related Quality of Life
Hide Description

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.

Time Frame at least 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
5 out of 16 patients were excluded from analysis due to missing EOS data.
Arm/Group Title SOM230 LAR
Hide Arm/Group Description:
SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: units on a scale
Physical function (SCR) 58.6  (28.9)
Physical function (EOS) 49.1  (25.6)
Role limitations due to physical health (SCR) 31.8  (38.9)
Role limitations due to physical health (EOS) 34.1  (45.1)
Pain (SCR) 57.3  (28.8)
Pain (EOS) 52.3  (35.7)
General health (SCR) 53.2  (12.9)
General health (EOS) 47.1  (14.5)
Energy/Fatigue (SCR) 43.6  (15.5)
Energy/Fatigue (EOS) 39.2  (21.3)
Social functioning (SCR) 61.4  (27.6)
Social functioning (EOS) 60.2  (30.5)
Role limitations due to emotional problems (SCR) 63.6  (45.8)
Role limitations due to emotional problems (EOS) 60.6  (44.3)
Emotional well-being (SCR) 60.4  (18.7)
Emotional well-being (EOS) 56.6  (20.9)
Change in health (general) (SCR) 38.6  (20.5)
Change in health (general) (EOS) 50.0  (15.8)
Time Frame Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).
Adverse Event Reporting Description An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Medical conditions/diseases present before starting study drug are only considered AE if they worsen after starting study drug.
 
Arm/Group Title SOM230 LAR
Hide Arm/Group Description SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks
All-Cause Mortality
SOM230 LAR
Affected / at Risk (%)
Total   0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
SOM230 LAR
Affected / at Risk (%) # Events
Total   7/16 (43.75%)    
Blood and lymphatic system disorders   
Anaemia  1  1/16 (6.25%)  1
General disorders   
Non-cardiac chest pain  1  1/16 (6.25%)  1
Systemic inflammatory response syndrome  1  1/16 (6.25%)  1
Infections and infestations   
Pneumonia  1  1/16 (6.25%)  1
Sepsis  1  1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Foot fracture  1  1/16 (6.25%)  1
Spinal fracutre  1  1/16 (6.25%)  1
Metabolism and nutrition disorders   
Hyperglycaemia  1  3/16 (18.75%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Metastasis  1  1/16 (6.25%)  1
Tumor pain  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/16 (6.25%)  1
Vascular disorders   
Embolism  1  1/16 (6.25%)  1
Venous thrombosis  1  1/16 (6.25%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SOM230 LAR
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
Leukocytosis  1  3/16 (18.75%)  3
Endocrine disorders   
Cushing's syndrome  1  1/16 (6.25%)  1
Eye disorders   
Cataract  1  2/16 (12.50%)  2
Gastrointestinal disorders   
Diarrhoea  1  10/16 (62.50%)  12
Abdominal pain  1  3/16 (18.75%)  4
Vomiting  1  2/16 (12.50%)  2
Abdominal pain upper  1  1/16 (6.25%)  1
Abnormal faeces  1  1/16 (6.25%)  1
Flatulence  1  1/16 (6.25%)  1
Haemorrhoids  1  1/16 (6.25%)  1
Nausea  1  1/16 (6.25%)  1
Oral dysaesthesia  1  1/16 (6.25%)  1
General disorders   
Chest pain  1  3/16 (18.75%)  3
Fatigue  1  1/16 (6.25%)  1
Influenza like illness  1  1/16 (6.25%)  1
Malaise  1  1/16 (6.25%)  1
Oedema peripheral  1  1/16 (6.25%)  1
Peripheral swelling  1  1/16 (6.25%)  1
Pyrexia  1  1/16 (6.25%)  1
Immune system disorders   
Immunodeficiency  1  1/16 (6.25%)  1
Infections and infestations   
Cystitis  1  2/16 (12.50%)  2
Nasopharyngitis  1  2/16 (12.50%)  2
Skin infection  1  2/16 (12.50%)  2
Bacterial infection  1  1/16 (6.25%)  1
Oral candidiasis  1  1/16 (6.25%)  1
Oral herpes  1  1/16 (6.25%)  1
Penile infection  1  1/16 (6.25%)  1
Vaginal infection  1  1/16 (6.25%)  1
Injury, poisoning and procedural complications   
Contusion  1  1/16 (6.25%)  1
Muscle strain  1  1/16 (6.25%)  1
Investigations   
Gamma-glutamyltransferase increased  1  2/16 (12.50%)  2
Blood creatine phosphokinase increased  1  1/16 (6.25%)  1
Glycosylated haemoglobin increased  1  1/16 (6.25%)  1
Troponin increased  1  1/16 (6.25%)  1
Weight decreased  1  1/16 (6.25%)  1
Metabolism and nutrition disorders   
Hyperglycaemia  1  4/16 (25.00%)  12
Diabetes mellitus  1  2/16 (12.50%)  2
Gout  1  1/16 (6.25%)  1
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  3/16 (18.75%)  3
Intervertebral disc protrusion  1  2/16 (12.50%)  2
Back pain  1  1/16 (6.25%)  1
Neck pain  1  1/16 (6.25%)  1
Pain in extremity  1  1/16 (6.25%)  1
Nervous system disorders   
Dizziness  1  1/16 (6.25%)  1
Dysgeusia  1  1/16 (6.25%)  1
Headache  1  1/16 (6.25%)  1
Peripheral sensory neuropathy  1  1/16 (6.25%)  1
Renal and urinary disorders   
Glycosuria  1  1/16 (6.25%)  1
Haematuria  1  1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/16 (6.25%)  1
Cough  1  1/16 (6.25%)  1
Epistaxis  1  1/16 (6.25%)  2
Haemoptysis  1  1/16 (6.25%)  1
Laryngeal inflammation  1  1/16 (6.25%)  1
Skin and subcutaneous tissue disorders   
Alopecia  1  1/16 (6.25%)  1
Erythema  1  1/16 (6.25%)  1
Skin hyperpigmentation  1  1/16 (6.25%)  1
Vascular disorders   
Flushing  1  1/16 (6.25%)  1
1
Term from vocabulary, MedDRA 19.0
Indicates events were collected by systematic assessment

Eval. of 3 intended secondary efficacy parameters was suspended due to scarcity of resources:

histopath. eval. of tumor samples, immunohistochem. eval. of tumor derived cells and eval. of changes in the subset composition of intratumorous T-cells

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Prof. Dr. Berthold Schalke
Organization: Klinik und Poliklinik für Neurologie der Universitaet Regensburg
Phone: +49 941 941 ext 3010
EMail: berthold.schalke@medbo.de
Layout table for additonal information
Responsible Party: Prof. Dr. Berthold Schalke, University of Regensburg
ClinicalTrials.gov Identifier: NCT02021942     History of Changes
Other Study ID Numbers: CSOM230CIC01T
First Submitted: December 20, 2013
First Posted: December 27, 2013
Results First Submitted: January 31, 2017
Results First Posted: February 2, 2018
Last Update Posted: February 2, 2018