Phase 2
N=57
Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET
Gastroenteropancreatic Neuroendocrine Tumors
Bottom Line
View on ClinicalTrials.gov: NCT02231762 ↗Enrolled (actual)
57
Serious AEs
29.8%
Results posted
May 2019
Primary outcome: Primary: Disease Control Rate (DCR) After 6 Months — 73.5 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lanreotide Autogel 120 mg (Drug); Temozolomide (TMZ) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ipsen
- Primary completion
- Dec 2016
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 | — |
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)
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.