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

NCT02231762 | Completed Phase 2 Results

• 2 other identifiers: A-94-52030-2682013-001697-17
• Study Type: interventional
• Target: 57
• Locations: 2 countries
• Sites: 10

Brief 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

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR) After 6 Months

  All tumour assessments were performed using the Response Evaluation Criteria In Solid Tumours (RECIST) criteria (1.1). Computer Tomography (CT-scan) or Magnetic Resonance Imaging (MRI) could be used for as method of tumour measurement and the same method of tumour measurement was used throughout the study for each subject. CT scans/MRI were performed at screening or baseline visit then at weeks 12, 24 and at early withdrawal or at anytime during the study in the case of any clinical or biological signs of tumour progression. The DCR was defined as the proportion of subjects with a response of CR, PR or SD after 6 months of combination treatment and was described in the ITT population along with its 95% Confidence Interval (CI) and was compared to 45% with an exact binomial proportion test. The Last Observation Carried Forward (LOCF) method was used to replace missing assessments at the end of the combination phase.

  6 months

Secondary Outcomes (16)

• DCR After 12 Months

  12 months

• Progression-Free Survival (PFS) Within 12 Months

  12 months

• Time To Response (TtR) Within 12 Months

  12 months

• Duration of Response (DoR) Within 12 Months

  12 months

• The Number of Subjects With a Biochemical Response Using Chromogranin-A (CgA) Levels After 6 Months

  6 months

Study Arms (1)

Lanreotide Autogel 120mg & Temozolomide

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.

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

Interventions

Lanreotide Autogel 120 mg DRUG

Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days).

Lanreotide Autogel 120mg & Temozolomide

Temozolomide (TMZ) DRUG

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.

Lanreotide Autogel 120mg & Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• Has the diagnosis of Insulinoma
• Has a diagnosis of a multiple endocrine neoplasia (MEN)

Sponsors & Collaborators

• Ipsen: lead

Study Sites (10)

Vienna General Hospital

Vienna, 1090, Austria

Location

Zentralklinik Bad Berka

Bad Berka, 99437, Germany

Location

Charité University Hospital

Berlin, 13353, Germany

Location

University Hospital Essen

Essen, 45122, Germany

Location

ENDOC Hamburg

Hamburg, 20357, Germany

Location

Oncological Center Leer

Leer, 26789, Germany

Location

University Hospital Mainz

Mainz, 55131, Germany

Location

University Hospital Mannheim

Mannheim, 68167, Germany

Location

University Hospital Marburg

Marburg, 35043, Germany

Location

University Hospital Munich

Munich, 81377, Germany

Location

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Ipsen

clinical.trials@ipsen.com

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: June 1, 2017
• Last Updated: May 6, 2019
• Results First Posted: May 6, 2019

Record last verified: 2019-02

Locations

DE (9); AU (1)