Efficacy of Octreotide Treatment in Patients With Primary... | NCT00332969

Studies
Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

NCT00332969

Sponsor

Novartis Pharmaceuticals

Status

Completed

Last Update Posted

Mar 31, 2017Actual

Enrollment

25Actual

Phase

Phase 2

Conditions

Thymoma

Interventions

Octreotide

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Oct 2010Actual

Completion Date

Not provided

First Submitted Date

Jun 1, 2006

First Submission Date that Met QC Criteria

Jun 1, 2006

First Posted Date

Jun 2, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 30, 2017

Last Update Posted Date

Mar 31, 2017Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
Sandostatin	Experimental		Drug: Octreotide

Name	Type	Description	Arm Group Labels	Other Names
Octreotide	Drug		Sandostatin

Measure	Description	Time Frame
Shrinkage of tumor size and diameter of 3 respectively 6 months		6 months

Measure	Description	Time Frame
Resection status after 3 respectively 6 months		3 - 6 months

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmeceuticals	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27992479	Result	Kirzinger L, Boy S, Marienhagen J, Schuierer G, Neu R, Ried M, Hofmann HS, Wiebe K, Strobel 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 Recurrent Unresectable Thymic Tumors: A Phase II Study. PLoS One. 2016 Dec 16;11(12):e0168215. doi: 10.1371/journal.pone.0168215. eCollection 2016.

ID	Term
D013945	Thymoma
D004194	Disease
D009369	Neoplasms

ID	Term
D018193	Neoplasms, Complex and Mixed
D009370	Neoplasms by Histologic Type
D013953	Thymus Neoplasms
D013899	Thoracic Neoplasms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides