Efficacy and Safety Study in Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg

Status:	Recruiting
Conditions:	Brain Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	7/30/2016
Start Date:	November 2015
End Date:	October 2019
Contact:	Ipsen Recruitment Enquiries
Email:	clinical.trials@ipsen.com

Efficacy and Safety of Lanreotide Autogel® 120 mg Administered Every 14 Days in Well Differentiated, Metastatic or Locally Advanced, Unresectable Pancreatic or Midgut Neuroendocrine Tumours Having Progressed Radiologically While Previously Treated With Lanreotide Autogel® 120 mg Administered Every 28 Days

This study aims to explore the efficacy and safety of lanreotide Autogel® 120 mg
administered every 14 days in subjects with grade 1 or 2, metastatic or locally advanced,
unresectable pancreatic or intestinal neuroendocrine tumours (NETs) once they have
progressed on the standard dose of lanreotide Autogel® 120 mg every 28 days.

Inclusion Criteria:

- Histopathologically confirmed, grade 1 or 2, metastatic or locally advanced,
unresectable pNET (pNET cohort) or midgut NET (midgut cohort) with or without hormone
related syndromes, with a proliferation index (Ki67) ≤20%.

- Positive somatostatin receptors type 2

- Progression as assessed by an independent central reviewer according to RECIST v1.0
while receiving first line treatment with lanreotide Autogel® at a standard dose of
120 mg every 28 days for at least 24 weeks

Exclusion Criteria:

- Grade 3 or rapidly progressive (within 12 weeks) NET

- Any NET other than pancreatic and midgut

- Previous treatment with any antitumour agent for NET other than lanreotide Autogel®
120 mg every 28 days

- Gallbladder lithiasis at Screening echography or history of cholelithiasis with no
cholecystectomy since then.

We found this trial at

sites

Cedars-Sinai Medical Center

8700 Beverly Blvd # 8211
Los Angeles, California 90048

(1-800-233-2771)