Status:
COMPLETED
Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Lead Sponsor:
Ipsen
Conditions:
Gastroenteropancreatic Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 neuroendocr...
Eligibility Criteria
Inclusion
- 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
- Has the diagnosis of Insulinoma
- Has a diagnosis of a multiple endocrine neoplasia (MEN)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT02231762
Start Date
October 1 2014
End Date
June 1 2017
Last Update
May 6 2019
Active Locations (10)
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1
Vienna General Hospital
Vienna, Austria, 1090
2
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
3
Charité University Hospital
Berlin, Germany, 13353
4
University Hospital Essen
Essen, Germany, 45122