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

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