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

NCT02231762 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2019-05-06

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02231762 on ClinicalTrials.gov