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Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET

Phase II, Multicentre, Open Label Study to Evaluate the Efficacy of the Combination of Lanreotide Autogel 120mg and Temozolomide in Patients With Progressive Gastro-entero-pancreatic Neuroendocrine Tumours (GEP-NET) G1/G2 - A Pilot-Study

NCT02231762•Ipsen

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 (10)

Vienna General Hospital

Vienna, Austria

Zentralklinik Bad Berka

Bad Berka, Germany

Charité University Hospital

Berlin, Germany

University Hospital Essen

Essen, Germany

ENDOC Hamburg

Hamburg, Germany

Oncological Center Leer

Leer, Germany

University Hospital Mainz

Mainz, Germany

University Hospital Mannheim

Mannheim, Germany

University Hospital Marburg

Marburg, Germany

University Hospital Munich

Munich, Germany

Key Dates

Start Date

October 1, 2014

Primary Completion Date

December 1, 2016

Completion Date

June 1, 2017

Last Updated

May 6, 2019

Enrollment

ACTUAL participants

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Interventions

Lanreotide Autogel 120 mg

DRUG

Temozolomide (TMZ)

DRUG

177Lutetium-octreotate Treatment Prediction Using Multimodality Imaging in Refractory NETs

NCT01842165

Gastroenteropancreatic Neuroendocrine Tumors

View study

COMPLETEDNA

TEP With 68-DOTANOC in Gastroenteropancreatic Neuroendocrine Tumors

NCT01747096

Patients With Gastroenteropancreatic Neuroendocrine Tumors

View study

TERMINATEDPHASE1/PHASE2

Diagnostic Accuracy of Gallium-68-DOTATATE PET/CT Compared to Indium-111-pentetreotide Scintigraphy (SPECT/CT) for Gastroenteropancreatic Neuroendocrine Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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