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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. Identifier: NCT02021942
Recruitment Status : Completed
First Posted : December 27, 2013
Results First Posted : February 5, 2018
Last Update Posted : February 5, 2018
Crolll Gmbh
Information provided by (Responsible Party):
Prof. Dr. Berthold Schalke, University of Regensburg

Brief Summary:
This is a monocenter, single-arm, open label phase II trial evaluating the effect of SOM230 LAR in adult patients with inoperable primary thymoma and thymoma metastasis (Masaoka II-IVa). SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks. The purpose of this trial is a proof of concept.

Condition or disease Intervention/treatment Phase
Primary Inoperable Thymoma Local Recurrent Thymoma Drug: SOM230 LAR Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thymus Cancer
Drug Information available for: Pasireotide

Arm Intervention/treatment
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.
Other Names:
  • Pasireotide
  • Sandostatin®

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. Assessment of Tumor Operability [ Time Frame: at least 6 months ]
    Assessment if patients reaching operability at the EOS.

Other Outcome Measures:
  1. Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: at least 6 months ]
  2. 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.

  3. 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.

  4. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients aged ≥18 years
  • Diagnosis of thymoma as assessed by biopsy and/or szintigraphy
  • Inoperability of thymoma or loco-regional metastases. Inoperability is defined as at least adherence of the tumor to the neighbored organs, suspicious to infiltrate neighbored organs or local metastasis so that R0 resection can not be expected and /or local recurrence of thymic tumor
  • Tumor stage: Thymomas of all WHO based histological subtypes (WHO A, AB, B1, B2, B3) (Rosai, 1999; Travis 2004) at Masaoka stage II to IVa based on histological examination of resection specimens or core biopsies.
  • Patients with and without thymoma associated paraneoplastic syndrome.
  • Performance status 0,1, or 2 (ECOG)
  • Patients for whom written informed consent to participate in the study has been obtained

Exclusion Criteria:

  • Patients having received radiolabeled somatostatin analogue therapy within the 6 months or any cytotoxic chemotherapy or interferon therapy within the 2 months prior to recording baseline symptoms
  • Patients who have undergone major surgery/surgical therapy for any cause within 1 month or surgical therapy of loco-regional metastases within the last 3 months before recording baseline symptoms
  • Patients who have received radiotherapy for any reason within the last 4 weeks and must have recovered from any side effects of radiotherapy before recording baseline symptoms
  • Patients who are not biochemically euthyroid
  • Diabetic patients on antidiabetic medications whose fasting blood glucose is poorly controlled as indicated by HbA1C > 8%
  • Patients with symptomatic cholelithiasis
  • Patients who have congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, ventricular fibrillation, clinically significant bradycardia, advanced heart block or a history of acute myocardial infarction within the six months preceding enrollment
  • Patients with QT related risk factor: QTcF at screening > 450 msec
  • Patients with QT related risk factor: History of syncope or family history of idiopathic sudden death
  • Patients with QT related risk factor:Sudden or clinically significant cardiac arrhythmias
  • Patients with QT related risk factor: Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia, cardiac failure, clinically significant / symptomatic bradycardia, or high-grade AV block
  • Patients with QT related risk factor: Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism or cardiac failure
  • Patients with QT related risk factor: Concomitant medication(s) known to increase the QT interval
  • Patients with potassium <3.0 mmol/L at study entry, magnesium <0.4 mmol/L at study entry, calcium <1.75 mmol/L at study entry, family history of long QT syndrome, and concomitant medications known to prolong the QT interval. If the electrolyte abnormalities are corrected prior to study commencement, the patient may become eligible for the trial.
  • Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis with serum bilirubin > 1.5 X ULN, serum albumin < 0.67 X LLN, and/or ALT or AST more than 2 X ULN for patients without liver Confidential - 20 - Amended Clinical Study Protocol v01 / Track Changes Study No. CSOM230CIC01T metastases or ALT or AST more than 5X ULN for patients with documented liver metastases
  • Patients with additional active malignant disease within the last five years (with the exception of basal cell carcinoma or carcinoma in situ of the cervix)
  • Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunocompromise, including a positive HIV test result (ELISA and Western blot). A HIV test will not be required; however, previous medical history will be reviewed
  • Patients with abnormal coagulation (PT or APTT elevated by 30% above normal limits)
  • Patients with WBC <2.5 X 109/L; Hgb <10 g/dL; PLT <100 X 109/L (patients with paraneoplastic pan-, leuco-, erythro- or thrombopenia can be included if this seems to be the only reason for pan-, leuco-, erythro- or thrombopenia)
  • Known hypersensitivity to somatostatin analogues or any component of the pasireotide or octreotide LAR or s.c. formulations
  • Patients who have any current or prior medical condition that may interfere with the conduct of the study or the evaluation of its results in the opinion of the investigator
  • Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. Female patients must use a secure method of contraception if sexually active and the partner should use a condom. If oral contraception is used, the patient must have been practicing this method for at least two months prior to enrollment and must agree to continue the oral contraceptive throughout the course of the study, and for three months after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three months afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs). Female partners of these male patients should use a secondary barrier contraception.
  • Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 1 month prior to dosing
  • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will not be able to complete the entire study
  • Patient has received any other investigational agents within 28 days of first day of study drug dosing
  • Abnormal clinical laboratory values considered by the investigator to be clinically significant and which could affect the interpretation of the study results

Information from the National Library of Medicine

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 identifier (NCT number): NCT02021942

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Klinik und Poliklinik für Neurologie der Universität Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
Prof. Dr. Berthold Schalke
Crolll Gmbh
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Principal Investigator: Berthold Schalke, Prof. Dr. Professor
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Responsible Party: Prof. Dr. Berthold Schalke, University of Regensburg Identifier: NCT02021942    
Other Study ID Numbers: CSOM230CIC01T
First Posted: December 27, 2013    Key Record Dates
Results First Posted: February 5, 2018
Last Update Posted: February 5, 2018
Last Verified: July 2017
Keywords provided by Prof. Dr. Berthold Schalke, University of Regensburg:
primary inoperable thymoma
local recurrent thymoma
reduction of tumor size
Additional relevant MeSH terms:
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Thymus Neoplasms
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Thoracic Neoplasms
Neoplasms by Site
Lymphatic Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs