Text Size

Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00332969
First received: June 1, 2006
Last updated: November 23, 2011
Last verified: November 2011
History of Changes

June 1, 2006
November 23, 2011
September 2005
October 2010   (final data collection date for primary outcome measure)
Shrinkage of tumor size and diameter of 3 respectively 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Shrinkage of tumor size and diameter of 3 respectively 6 months
Complete list of historical versions of study NCT00332969 on ClinicalTrials.gov Archive Site
Resection status after 3 respectively 6 months [ Time Frame: 3 - 6 months ] [ Designated as safety issue: No ]
Resection status after 3 respectively 6 months
Not Provided
Not Provided
 
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma
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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Thymoma
Drug: Octreotide
Experimental: Sandostatin
Intervention: Drug: Octreotide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
Not Provided
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00332969
CSMS995ADE13
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
Novartis
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP