NCT02231762

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Ipsen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gastroenteropancreatic Neuroendocrine Tumors

Interventions

Type	Name	Description
DRUG	Lanreotide Autogel 120 mg	Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days).
DRUG	Temozolomide (TMZ)	Temozolomide capsule (variable dose). 150 mg/m2 per day for 5 days in the first month. 200 mg/m2 per day for 5 days in months 2, 3, 4, 5 and 6.

Timeline

• Start date: 2014-10-01
• Primary completion: 2016-12-01
• Completion: 2017-06-01
• First posted: 2014-09-04
• Last updated: 2019-05-06
• Results posted: 2019-05-06

Locations

10 sites across 2 countries: Austria, Germany