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

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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
5
sites
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Bruxelles,
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New Orleans, Louisiana 70121
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New Orleans, LA
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Philadelphia, Pennsylvania 19111
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Philadelphia, PA
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