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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00332969
Other study ID # CSMS995ADE13
Secondary ID
Status Completed
Phase Phase 2
First received June 1, 2006
Last updated March 30, 2017
Start date September 2005

Study information

Verified date November 2011
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date
Est. primary completion date October 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female patients aged >18 years

2. 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.

3. Positive result in SMS-szintigraphy,

4. 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.

5. Patients with and without thymoma associated paraneoplastic syndrome

6. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.

Exclusion Criteria:

1. Performance status 0,1, or 2 (ECOG)

2. Symptomatic cholelithiasis,

3. Pretreatment with octreotide (longn acting release) within the 3 months

4. Patient has received any other investigational agents within 28 days of first day of study drug dosing

5. 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

6. 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Octreotide


Locations

Country Name City State
Germany Novartis Investigative Site Regensburg

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Kirzinger L, Boy S, Marienhagen J, Schuierer G, Neu R, Ried M, Hofmann HS, Wiebe K, Ströbel P, May C, Kleylein-Sohn J, Baierlein C, Bogdahn U, Marx A, Schalke B. Octreotide LAR and Prednisone as Neoadjuvant Treatment in Patients with Primary or Locally Re — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Shrinkage of tumor size and diameter of 3 respectively 6 months 6 months
Secondary Resection status after 3 respectively 6 months 3 - 6 months
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