Primary Inoperable ThymomaPhase 2NCT02021942

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

A Phase 2 study testing SOM230 LAR in people with Primary Inoperable Thymoma and Local Recurrent Thymoma, run by Prof. Dr. Berthold Schalke at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Inoperable Thymoma, Local Recurrent Thymoma
What is being tested?: SOM230 LAR
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteGermany
Study dates: Mar 2012to Oct 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 26Show fewer

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

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinik und Poliklinik für Neurologie der Universität Regensburg
Regensburg, Bavaria, 93053

Other trials in Germany

About this study

Conditions: Primary Inoperable Thymoma, Local Recurrent Thymoma
Being tested: SOM230 LAR
Keywords: primary inoperable thymoma, local recurrent thymoma, reduction of tumor size, SOM230 LAR

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SOM230 LARDrug
Also called Pasireotide, Sandostatin®
SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.

Study groups in NCT02021942
Study group	Role	What they receive
SOM230 LAR	Experimental	SOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks Receives: Drug: SOM230 LAR

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: at least 6 months

Secondary outcomes (2)

Tumor Resection Status
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).
Measured: at least 6 months
Assessment of Tumor Operability
Assessment if patients reaching operability at the EOS.
Measured: at least 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2012Oct 2015

First posted27 Dec 2013 (estimated)
Study startMar 2012
Primary completionOct 2015
Study completionOct 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary Inoperable ThymomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02021942
Sponsor's protocol ID: CSOM230CIC01T
Status last verified: Jul 2017
First submitted: 20 Dec 2013
Last updated: 5 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02021942
Acronym / sponsor ID: CSOM230CIC01T
Conditions: Primary Inoperable Thymoma, Local Recurrent Thymoma
Keywords: primary inoperable thymoma, local recurrent thymoma, reduction of tumor size, SOM230 LAR
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Prof. Dr. Berthold SchalkeUniversity, hospital or other
Collaborators: Crolll Gmbh
Study start: Mar 2012
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 27 Dec 2013 (estimated)
Results: Posted 5 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
SOM230 LAR	Experimental	Drug: SOM230 LARSOM230 LAR in a dosage of 60 mg i.m. once every 4 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (26 listed)

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%

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SOM230 LARAlso: Pasireotide, Sandostatin®SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.	Drug	SOM230 LAR

Primary outcome

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.

2 secondary outcomes

Tumor Resection Status
Time frame: at least 6 months
Assessment of Tumor Operability
Time frame: at least 6 months

Results and safety

Results posted to the registry on 5 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SOM230 LAR	16	16

Primary outcome: Percent Change in Tumor Volume From Baseline to EOS

Time frame: at least 6 months. Mean (95% Confidence Interval). Unit: percentage of tumor volume

Measure	SOM230 LAR n = 16
Value	-37.38 (-60.88 to -13.88)

Population analysed: 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).

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline, i.e. start of study drug, through study completion (EOS, including four weeks following the last dose of study drug).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SOM230 LAR	7 of 16 (43.8%)	16 of 16 (100%)	0 of 16

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Berthold Schalke, Prof. Dr. principal investigator

Professor

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOM230 LAR in people with Primary Inoperable Thymoma and Local Recurrent Thymoma, run by Prof. Dr. Berthold Schalke at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Tumor Volume From Baseline to EOS (time frame: at least 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02021942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.