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

Ipsen

Status and phase: Completed; Phase 2

Conditions: Gastroenteropancreatic Neuroendocrine Tumors

Treatments: Drug: Lanreotide Autogel 120 mg; Drug: Temozolomide (TMZ)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02231762

A-94-52030-268

2013-001697-17 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

57 participants in 1 patient group

Lanreotide Autogel 120mg & Temozolomide

Experimental group

Description:

Combination phase for first 6 months: Lanreotide Autogel 120 mg and Temozolomide. Followed by either 6 months Lanreotide Autogel 120 mg maintenance or 6 months of no treatment.

Treatment:

Drug: Temozolomide (TMZ)

Drug: Lanreotide Autogel 120 mg