Clinical trial NCT02231762: Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroenteropancreatic Neuroendocrine Tumors
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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)

Primary outcomes:
measure: Disease Control Rate (DCR) After 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: DCR After 12 Months
timeFrame: 12 months
measure: Progression-Free Survival (PFS) Within 12 Months
timeFrame: 12 months
measure: Time To Response (TtR) Within 12 Months
timeFrame: 12 months
measure: Duration of Response (DoR) Within 12 Months
timeFrame: 12 months
measure: The Number of Subjects With a Biochemical Response Using Chromogranin-A (CgA) Levels After 6 Months
timeFrame: 6 months
measure: The Number of Subjects With a Biochemical Response Using CgA Levels After 12 Months
timeFrame: 12 months
measure: The Number of Subjects With a Biochemical Response Using 5-Hydroxy-Indol-Amino-Acid (HIAA) Levels After 6 Months
timeFrame: 6 months
measure: The Number of Subjects With a Biochemical Response Using 5-HIAA Levels After 12 Months
timeFrame: 12 months
measure: The Number of Subjects With a Symptomatic Response After 6 Months
timeFrame: 6 months
measure: The Number of Subjects With a Symptomatic Response After 12 Months - Maintenance Phase
timeFrame: 12 months
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Core 30 Questionnaire (QLQ-C30): Mean Change From Baseline at 6 Months
timeFrame: 6 months
measure: EORTC QoL Questionnaire QLQ-C30: Mean Change From Baseline at 12 Months
timeFrame: 12 months
measure: Quality of Life Gastrointestinal Neuroendocrine Tumour 21 Questionnaire (QLQ-GI.NET21): Mean Change From Baseline at 6 Months
timeFrame: 6 months
measure: QoL Questionnaire QLQ-GI.NET21: Mean Change From Baseline at 12 Months
timeFrame: 12 months
measure: DCR by O6-methylguanine-DNA Methyl-transferase (MGMT) Expression and Methylation and Somatostatin Receptor (SSTR) Expression After 6 Months
timeFrame: 6 months
measure: Pharmacokinetic (PK) Results: Lanreotide ATG 120 mg Serum Concentrations Within 12 Months
timeFrame: Baseline (week 1) and weeks 4, 12, 24 and 48
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna General Hospital
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Berlin
country: Germany
facility: Charité University Hospital
city: Essen
country: Germany
facility: University Hospital Essen
city: Hamburg
country: Germany
facility: ENDOC Hamburg
city: Leer
country: Germany
facility: Oncological Center Leer
city: Mainz
country: Germany
facility: University Hospital Mainz
city: Mannheim
country: Germany
facility: University Hospital Mannheim
city: Marburg
country: Germany
facility: University Hospital Marburg
city: Munich
country: Germany
facility: University Hospital Munich
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: