Efficacy of Medical Treatment With SOM230 LAR in Patients With Primary Inoperable Thymoma and/or With Local Recurrent Thymoma to Reduce Tumor Size

NCT02021942 | Completed Phase 2 Results

• 1 other identifier: CSOM230CIC01T
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Inoperable Thymoma; Local Recurrent Thymoma

Keywords

primary inoperable thymoma; local recurrent thymoma; reduction of tumor size; SOM230 LAR

Outcome Measures

Primary Outcomes (1)

• Percent Change in Tumor Volume From Baseline to EOS

  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.

  at least 6 months

Secondary Outcomes (2)

• Tumor Resection Status

  at least 6 months

• Assessment of Tumor Operability

  at least 6 months

Other Outcomes (4)

• Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

  at least 6 months

• Assessment of Myasthenia Gravis (MG) Status by Determining Titin-antibody Status

  at least 6 months

• Assessment of Myasthenia Gravis (MG) Status by Measuring ACHR-antibody Concentrations

  at least 6 months

Study Arms (1)

SOM230 LAR

EXPERIMENTAL

SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks

Drug: SOM230 LAR

Interventions

SOM230 LAR DRUG

SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.

Also known as: Pasireotide, Sandostatin®

SOM230 LAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Berthold Schalke: lead
• Crolll Gmbh: collaborator

Study Sites (1)

Klinik und Poliklinik für Neurologie der Universität Regensburg

Regensburg, Bavaria, 93053, Germany

Location

MeSH Terms

Interventions

pasireotide; Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

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

Results Point of Contact

• Title: Prof. Dr. Berthold Schalke
• Organization: Klinik und Poliklinik für Neurologie der Universitaet Regensburg

berthold.schalke@medbo.de

+49 941 941

Study Officials

• Berthold Schalke, Prof. Dr.

  Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. Berthold Schalke

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: March 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 5, 2018
• Results First Posted: February 5, 2018

Record last verified: 2017-07

Locations

DE (1)