Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Phase 2

Completed

• Conditions: Thymoma
• Interventions: Drug: Octreotide

• Registration Number: NCT00332969
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-06-01
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2010-10
• Status Verified: 2011-11
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sandostatin	Octreotide	-

Primary Outcome Measures

Name	Time	Method
Shrinkage of tumor size and diameter of 3 respectively 6 months	6 months

Secondary Outcome Measures

Name	Time	Method
Resection status after 3 respectively 6 months	3 - 6 months

Trial Locations

Locations (1)

Novartis Investigative Site; 🇩🇪 Regensburg, Germany