CompletedPhase 2

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

Austria, Germany57 participantsStarted 2014-10

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Disease Control Rate (DCR) After 6 Months

Timeframe: 6 months

Trial details

NCT IDNCT02231762

SponsorIpsen

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-12

Results submitted2018-07-18

View on ClinicalTrials.gov More Gastroenteropancreatic Neuroendocrine Tumors trials