Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

Neuroendocrine Tumor Clinical Trial

Official title:

Retrospective Analysis of Patients Re-treated With Lutetium-177 DOTATATE (Lutathera®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05816720
• Other study ID #: CAAA601A1US08
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This was a retrospective non-interventional study evaluating the medical records of patients with neuroendocrine tumor (NET) re-treated with lutetium-177 DOTATATE at a single United States institution - the Excel Diagnostics & Nuclear Oncology Center in Houston, Texas. Initial treatment was defined as the initial regimen of up to 4 doses of Lutetium-177 DOTATATE received by each patient; re-treatment was defined as any additional dose(s) of lutetium-177 DOTATATE given after the patient progressed following the initial treatment, with a minimum time interval of 6 months between the initial treatment and re-treatment.

The study period was from 01 January 2010 to 30 June 2021. The index date was the date of the first ever treatment with lutetium-177 DOTATATE, and the index re-treatment date was the date of the first re-treatment dose of lutetium-177 DOTATATE received. The index (identification) period was from 01 July 2010 to 31 December 2020 to account for minimum 6-month baseline and follow-up periods. Patients were followed from the index date to the occurrence of one of the following events (whichever came first):

1. Date of death - the date at which a patient was reported in the database as having died

2. Last month active - the last recorded mention of the patient in the dataset

3. End of data window - end of the dataset Patient characteristics were assessed at both the index date and the index re-treatment date. Real-world effectiveness and safety outcomes were also assessed from the index date and from the index re-treatment date.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• Diagnosis of any NET

• Evidence of re-treatment with lutetium-177 DOTATATE

• Documentation of initial treatment with a regimen of up to 4 doses of lutetium-177 DOTATATE, followed by evidence of progression, and then =1 subsequent dose of lutetium-177 DOTATATE

• Minimum of 6 months between the end of the initial treatment doses and the first re-treatment dose

Exclusion criteria

• <18 years of age

Related Conditions & MeSH terms

• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• Lutetium-177 DOTATATE
Intravenous administration

Locations

Country	Name	City	State
United States	Excel Diagnostics & Nuclear Oncology Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival	Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of progression or death	Up to approximately 11 years
Primary	Overall survival	Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death	Up to approximately 11 years
Primary	Percentage of patients with treatment response	Best overall response was defined per Response Evaluation Criteria In Solid Tumors (RECIST), 1.1. Overall response: complete response (CR) + partial response (PR); CR; PR; stable disease (SD); and progressive disease (PD)	Up to approximately 11 years
Secondary	Number of patients with adverse events (AEs)		Up to approximately 11 years
Secondary	Mean change from baseline in white blood cell (WBC) count		Up to approximately 11 years
Secondary	Mean change from baseline in hemoglobin		Up to approximately 11 years
Secondary	Mean change from baseline in absolute neutrophil count (ANC)		Up to approximately 11 years
Secondary	Mean change from baseline in lymphocyte count		Up to approximately 11 years
Secondary	Mean change from baseline in platelet count		Up to approximately 11 years
Secondary	Mean change from baseline in alkaline phosphatase (ALP)		Up to approximately 11 years
Secondary	Mean change from baseline in alanine aminotransferase (ALT)		Up to approximately 11 years
Secondary	Mean change from baseline in aspartate aminotransferase (AST)		Up to approximately 11 years
Secondary	Mean change from baseline in albumin		Up to approximately 11 years
Secondary	Mean change from baseline in bilirubin		Up to approximately 11 years
Secondary	Mean change from baseline in creatinine		Up to approximately 11 years
Secondary	Mean change from baseline in estimated glomerular filtration rate (eGFR)		Up to approximately 11 years
Secondary	Mean change from baseline in cromogranin A		Up to approximately 11 years
Secondary	Mean change from baseline in pancreatic polypeptide		Up to approximately 11 years
Secondary	Mean change from baseline in pancreastatin		Up to approximately 11 years
Secondary	Number of patients who received other treatments prior to initial treatment with lutetium-177 DOTATATE		Prior to initial treatment with lutetium-177 DOTATATE
Secondary	Number of patients who received lutetium-177 DOTATATE, categorized by number of doses		Up to approximately 11 years
Secondary	Number of patients who received lutetium-177 DOTATATE, categorized by treatment stage		Up to approximately 11 years
Secondary	Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage		Up to approximately 11 years