Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Gastroenteropancreatic Neuroendocrine Tumors
Conditions: official terms
Apudoma - Carcinoid Tumor - Intestinal Neoplasms - Neuroendocrine Tumors - Pancreatic Neoplasms - Stomach Neoplasms
Study Type
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Lanreotide Autogel 120 mg Type: Drug
Name: Temozolomide (TMZ) Type: Drug
Overall Status
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)
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
Record processing date processed this data on July 28, 2015 page