Phase 2
Completed N=57
Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Source: ClinicalTrials.gov NCT02231762 ↗Enrolled (actual)
57
Serious AEs
29.8%
Results posted
May 2019
Primary outcomePrimary: Disease Control Rate (DCR) After 6 Months — 73.5 percentage of subjects
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disease Control Rate (DCR) After 6 Months |
73.5 | — |
| SECONDARY DCR After 12 Months |
54.5; 71.4; 41.7 | — |
| SECONDARY Progression-Free Survival (PFS) Within 12 Months |
11.1 | — |
| SECONDARY Time To Response (TtR) Within 12 Months |
NA | — |
| SECONDARY Duration of Response (DoR) Within 12 Months |
NA | — |
| SECONDARY The Number of Subjects With a Biochemical Response Using Chromogranin-A (CgA) Levels After 6 Months |
8; 15; 10; 1; 5; 9 | — |
| SECONDARY The Number of Subjects With a Biochemical Response Using CgA Levels After 12 Months |
2; 1; 2; 3; 4; 2 | — |
| SECONDARY The Number of Subjects With a Biochemical Response Using 5-Hydroxy-Indol-Amino-Acid (HIAA) Levels After 6 Months |
4; 6; 1; 6; 6; 3 | — |
| SECONDARY The Number of Subjects With a Biochemical Response Using 5-HIAA Levels After 12 Months |
6; 3; 1; 1; 3; 3 | — |
| SECONDARY The Number of Subjects With a Symptomatic Response After 6 Months |
4; 2; 5; 6; 4; 4 | — |
| SECONDARY The Number of Subjects With a Symptomatic Response After 12 Months - Maintenance Phase |
4; 1; 3; 3; 2; 3 | — |
| SECONDARY 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 |
-4.9; -9.6; -8.3; -4.7; -5.9; -11.8 | — |
| SECONDARY EORTC QoL Questionnaire QLQ-C30: Mean Change From Baseline at 12 Months |
-11.7; -3.1; -7.1; 8.0; -12.5; -11.4 | — |
| SECONDARY Quality of Life Gastrointestinal Neuroendocrine Tumour 21 Questionnaire (QLQ-GI.NET21): Mean Change From Baseline at 6 Months |
-1.0; 5.7; 3.6; 2.3; 1.6; 1.0 | — |
| SECONDARY QoL Questionnaire QLQ-GI.NET21: Mean Change From Baseline at 12 Months |
-13.3; -5.6; 1.6; -4.0; 0.0; 6.7 | — |
| SECONDARY DCR by O6-methylguanine-DNA Methyl-transferase (MGMT) Expression and Methylation and Somatostatin Receptor (SSTR) Expression After 6 Months |
100.0; 84.6; 90.9; 70.0; 86.7; 72.7 | — |
| SECONDARY Pharmacokinetic (PK) Results: Lanreotide ATG 120 mg Serum Concentrations Within 12 Months |
0.44; 2.45; 5.06; 5.83; 3.68 | — |
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)
Data sourced from ClinicalTrials.gov (NCT02231762). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.