Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Conditions
Gastroenteropancreatic Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Intestinal Neoplasms - Neuroendocrine Tumors - Pancreatic Neoplasms - Stomach Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Lanreotide Autogel 120 mg Type: Drug
Name: Temozolomide (TMZ) Type: Drug
Overall Status
Recruiting
Summary
The purpose of the study is to evaluate the efficacy and tolerability of the combination of Lanreotide Autogel 120 mg and Temozolomide in patients with progressive gastro-entero-pancreatic neuroendocrine tumours (GEP-NET) graded as G1 or G2 (G1/G2). All progressive tumours classified according to Response Evaluation Criteria In Solid Tumours (RECIST, 1.1).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Provision of written informed consent prior to any study related procedures

- Inoperable, Gastro-Entero-Pancreatic-Neuroendocrine Tumour G1 or G2 (Proliferation Index, Ki67-Index: 0 to ≤20%) confirmed by pathological/histological assessment

- Progressive disease within 12 months before inclusion (RECIST 1.1: increase of >20% tumour load; by Computer Tomography (CT) or Magnetic Resonance Imaging (MRI)

- Measurable disease according to RECIST 1.1.

- Metastatic disease confirmed by CT/MRI.

- Functioning or non-functioning NET (G1, G2).

- Positive Octreo-Scan (≥ Grade 2 Krenning scale) or positive DOTA (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid)-TATE (Tyr3-Thre8-Octreotide or DOTA-Tyr3-octreotate)/TOC (Tyr3-octreotide) -PET (Positron-Emission-Tomography) -CT within 12 months prior to screening

Exclusion Criteria:

- Has the diagnosis of Insulinoma

- Has a diagnosis of a multiple endocrine neoplasia (MEN)
Locations
Vienna General Hospital
Vienna, Austria
Status: Recruiting
Zentralklinik Bad Berka
Bad Berka, Germany
Status: Recruiting
Charité University Hospital
Berlin, Germany
Status: Recruiting
University Hospital Essen
Essen, Germany
Status: Not yet recruiting
ENDOC Hamburg
Hamburg, Germany
Status: Not yet recruiting
Oncological Center Leer
Leer, Germany
Status: Not yet recruiting
University Hospital Mainz
Mainz, Germany
Status: Active, not recruiting
University Hospital Mannheim
Mannheim, Germany
Status: Active, not recruiting
University Hospital Marburg
Marburg, Germany
Status: Recruiting
University Hospital Munich
Munich, Germany
Status: Active, not recruiting
Start Date
October 2014
Completion Date
October 2018
Sponsors
Ipsen
Source
Ipsen
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page