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

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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

Tracking Information
First Submitted Date September 22, 2018
First Posted Date October 1, 2018
Last Update Posted Date October 5, 2021
Actual Study Start Date November 28, 2018
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 25, 2018)
secondary cancers: incidence of secondary cancers [ Time Frame: up to 7 years follow-up ]
incidence of secondary cancers
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: September 29, 2018)
  • safety profile: incidence of adverse events [ Time Frame: up to 7 years follow-up ]
    incidence of adverse events
  • mortality [ Time Frame: up to 7 years follow-up ]
    mortality (all cause)
  • LUTATHERA dose per administration [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average dose per administration
  • LUTATHERA total dose [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average total dose administered
  • LUTATHERA number of administrations [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average number of LUTATHERA doses
Original Secondary Outcome Measures
 (submitted: September 25, 2018)
  • safety profile: incidence of adverse events [ Time Frame: up to 7 years follow-up ]
    incidence of adverse events
  • mortality [ Time Frame: up to 7 years follow-up ]
    mortality (all cause)
  • LUTATHERA dose per administration [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average dose per administration
  • LUTATHERA total dose [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average total dose admininistered
  • LUTATHERA number of administrations [ Time Frame: completion of treatment phase (approximately 2 years total) ]
    average number of LUTATHERA doses
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Authorization Long-Term Safety Study of LUTATHERA
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
Brief Summary Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients treated with LUTATHERA for the labeled indication using the approved dosing regimen.
Condition Neuroendocrine Tumors
Intervention 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
Study Groups/Cohorts LUTATHERA
Treated per labeled LUTATHERA dosing regimen.
Intervention: Drug: LUTATHERA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 25, 2018)
900
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2027
Estimated Primary Completion Date December 31, 2027   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Listed Location Countries France,   Portugal,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03691064
Other Study ID Numbers A-LUT-T-E02-402
CAAA601A12402 ( Other Identifier: Novartis )
EUPAS25735 ( Other Identifier: ENCePP )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Advanced Accelerator Applications
Study Sponsor Advanced Accelerator Applications
Collaborators Not Provided
Investigators
Study Director: Study Director Advanced Accelerator Applications
PRS Account Advanced Accelerator Applications
Verification Date October 2021