Post-Authorization Long-Term Safety Study of LUTATHERA

International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours

ClinicalTrials.gov Identifier: NCT03691064

Novartis Reference Number: A-LUT-T-E02-402

Last Update: Apr 26, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

Condition 
Neuroendocrine Tumors
Phase 
Not Given
Overall status 
Recruiting
Start date 
Nov 28, 2018
Completion date 
Dec 31, 2027
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
LUTATHERA
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.

Eligibility Criteria

Inclusion Criteria:

patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours treated with LUTATHERA

Exclusion Criteria:

hypersensitivity to LUTATHERA (active substance or any of the excipients)
pregnancy (established, suspected, or when not excluded)
kidney failure with creatinine clearance < 30 mL/min

Study Locations

United States
Banner MD Anderson Cancer Center
Recruiting
Phoenix, 85006
Arizona
United States
The Ohio State University Wexner Medical Center
Recruiting
Portland, 43210
Ohio
United States
Oregon Health & Sciences University Hospital
Recruiting
Portland, 97339 - Oregon
Contact: Erik Mittra, MD
United States
Virginia Mason in Seattle
Recruiting
Seattle, 98101 - Washington
Contact: Hagen Kennecke, MD
United States
France
Novartis Investigative site
Recruiting
Clichy,
-
France
Novartis Investigative site
Recruiting
Lyon,
-
France
Novartis Investigative site
Recruiting
Villejuif,
-
France
Portugal
Novartis Investigative site
Recruiting
Coimbra, 3000-075
Contact: Gracinda Costa, MD
Portugal
United Kingdom
Novartis Investigative site
Recruiting
Birmingham, B152WB
Contact: Tahir Shah, MD
United Kingdom
Novartis Investigative site
Recruiting
Cambridge, CB2 0QC
Contact: Ruth Casey (44 01223 217145)
United Kingdom
Novartis Investigative site
Recruiting
Glasgow, G12 OYN
-
United Kingdom
Novartis Investigative site
Recruiting
Liverpool, L7 8XP
Contact: Sobhan Vinjamuri, MD MS MBBS
United Kingdom
Novartis Investigative site
Recruiting
London, NW32QG
Contact: Shaunak Navalkissoor, MSc, MBChB
United Kingdom
Novartis Investigative site
Recruiting
London, SE1 9RT
Contact: Valerie Lewington, BM MSc FRCP FRCR
United Kingdom
Novartis Investigative site
Recruiting
London, SE5 9RS
Contact: Rajaventhan Srirajaskanthan, MD MD BS BSc MRCP
United Kingdom
Novartis Investigative site
Recruiting
London, W6 8RF
Contact: Rohini Sharma, MD
United Kingdom
Novartis Investigative site
Recruiting
Manchester,
-
United Kingdom
Novartis Investigative site
Recruiting
Scheffield, S102SJ
-
United Kingdom

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]