Overview

This trial is active, not recruiting.

Condition gastroenteropancreatic neuroendocrine tumors
Treatments lanreotide autogel 120 mg, temozolomide (tmz)
Phase phase 2
Sponsor Ipsen
Start date October 2014
End date October 2018
Trial size 56 participants
Trial identifier NCT02231762, 2013‐001697‐17, A-94-52030-268

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
lanreotide autogel 120 mg
Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days).
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.

Primary Outcomes

Measure
Disease control rate after 6 months
time frame: 6 months

Secondary Outcomes

Measure
Disease control rate after 12 months
time frame: 12 months
Time to disease progression or death
time frame: up to 12 months
Percentage of patients with normalized and stabilized Chromogranin A (CgA) levels after 6 months
time frame: 6 months
Percentage of patients with normalized and stabilized CgA-levels after 12 months
time frame: 12 months
Time to partial response within 12 months
time frame: 12 months
Time to complete response within 12 months
time frame: 12 months
Duration of partial response within 12 months
time frame: 12 months
Duration of complete response within 12 months
time frame: 12 months
Percentage change (greater than or equal to 50%) from baseline in CgA reduction at 12 months
time frame: Baseline, 12 months
Change from baseline in frequency of symptomatic episodes of diarrhoea after 6 months
time frame: Baseline, 6 months
Change from baseline in frequency of symptomatic episodes of flushing after 6 months
time frame: Baseline, 6 months
Change from baseline in frequency of symptomatic episodes of diarrhoea after 12 months
time frame: Baseline, 12 months
Change from baseline in frequency of symptomatic episodes of flushing after 12 months
time frame: Baseline, 12 months
Change from baseline in Quality of Life (QoL)
time frame: Baseline, 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ipsen.