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Post-Authorization Long-Term Safety Study of LUTATHERA (SALUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691064
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Advanced Accelerator Applications

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

Condition or disease Intervention/treatment
Neuroendocrine Tumors Drug: LUTATHERA

Detailed Description:
To assess the incidence and nature of potential long-term safety outcomes (follow-up period up to 7 years) in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: 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
Actual Study Start Date : November 28, 2018
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2027


Group/Cohort Intervention/treatment
LUTATHERA
Treated per labeled LUTATHERA dosing regimen.
Drug: LUTATHERA
Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.
Other Name: Lu 177 dotatate




Primary Outcome Measures :
  1. secondary cancers: incidence of secondary cancers [ Time Frame: up to 7 years follow-up ]
    incidence of secondary cancers


Secondary Outcome Measures :
  1. safety profile: incidence of adverse events [ Time Frame: up to 7 years follow-up ]
    incidence of adverse events

  2. mortality [ Time Frame: up to 7 years follow-up ]
    mortality (all cause)

  3. LUTATHERA dose per administration [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average dose per administration

  4. LUTATHERA total dose [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average total dose administered

  5. LUTATHERA number of administrations [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average number of LUTATHERA doses



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691064


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com

Locations
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United States, Arizona
Banner MD Anderson Cancer Center Recruiting
Phoenix, Arizona, United States, 85006
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Portland, Ohio, United States, 43210
United States, Oregon
Oregon Health & Sciences University Hospital Recruiting
Portland, Oregon, United States, 97339
Contact: Erik Mittra, MD         
United States, Washington
Virginia Mason in Seattle Recruiting
Seattle, Washington, United States, 98101
Contact: Hagen Kennecke, MD         
France
Hôpital Beaujon Recruiting
Clichy, France
Institut Gustave Roussy Recruiting
Villejuif, France
Portugal
Centro Hospitalar e Universitario de Coimbra, E.P.E. Recruiting
Coimbra, Portugal, 3000-075
Contact: Gracinda Costa, MD         
United Kingdom
Queen Elizabeth Hospital Recruiting
Birmingham, United Kingdom, B152WB
Contact: Tahir Shah, MD         
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom, CB2 0QC
Contact: Ruth Casey    44 01223 217145      
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 OYN
Royal Liverpool University Hospital Recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Sobhan Vinjamuri, MD MS MBBS         
Royal Free Hospital Recruiting
London, United Kingdom, NW32QG
Contact: Shaunak Navalkissoor, MSc, MBChB         
Guys Hospital Nuclear Medicine Department Recruiting
London, United Kingdom, SE1 9RT
Contact: Valerie Lewington, BM MSc FRCP FRCR         
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Rajaventhan Srirajaskanthan, MD MD BS BSc MRCP         
Hammersmith Hospital (Imperial) Recruiting
London, United Kingdom, W6 8RF
Contact: Rohini Sharma, MD         
Weston Park Hospital Recruiting
Scheffield, United Kingdom, S102SJ
Sponsors and Collaborators
Advanced Accelerator Applications
Investigators
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Study Director: Study Director Advanced Accelerator Applications
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Responsible Party: Advanced Accelerator Applications
ClinicalTrials.gov Identifier: NCT03691064    
Other Study ID Numbers: A-LUT-T-E02-402
CAAA601A12402 ( Other Identifier: Novartis )
EUPAS25735 ( Other Identifier: ENCePP )
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Advanced Accelerator Applications:
Gastroenteropancreatic neuroendocrine tumours
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Lutetium Lu 177 dotatate
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action