- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00332969
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
March 30, 2017 updated by: Novartis Pharmaceuticals
Efficacy of Medical Treatment With Octreotide in Patients With Primary Inoperable Thymoma to Reduce Tumor Size
This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Regensburg, Germany
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients aged >18 years
- Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected.
- Positive result in SMS-szintigraphy,
- Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens.
- Patients with and without thymoma associated paraneoplastic syndrome
- Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.
Exclusion Criteria:
- Performance status 0,1, or 2 (ECOG)
- Symptomatic cholelithiasis,
- Pretreatment with octreotide (longn acting release) within the 3 months
- Patient has received any other investigational agents within 28 days of first day of study drug dosing
- Patient is < 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
- Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)
Other protocol-defined inclusion/exclusion criteria apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Sandostatin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shrinkage of tumor size and diameter of 3 respectively 6 months
Time Frame: 6 months
|
6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Resection status after 3 respectively 6 months
Time Frame: 3 - 6 months
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3 - 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
June 1, 2006
First Submitted That Met QC Criteria
June 1, 2006
First Posted (ESTIMATE)
June 2, 2006
Study Record Updates
Last Update Posted (ACTUAL)
March 31, 2017
Last Update Submitted That Met QC Criteria
March 30, 2017
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSMS995ADE13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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