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

April 16, 2023 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77042
        • Excel Diagnostics & Nuclear Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Initial treatment
Patients who received initial treatment with lutetium-177 DOTATATE
Drug: Lutetium-177 DOTATATE
Intravenous administration
Other Names:
  • Lutathera®
Re-treatment
Patients who received re-treatment with lutetium-177 DOTATATE
Drug: Lutetium-177 DOTATATE
Intravenous administration
Other Names:
  • Lutathera®
Additional re-treatment
Patients who received additional re-treatment with lutetium-177 DOTATATE
Drug: Lutetium-177 DOTATATE
Intravenous administration
Other Names:
  • Lutathera®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: Up to approximately 11 years
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
Overall survival
Time Frame: Up to approximately 11 years
Time from the index date of treatment or re-treatment with lutetium-177 DOTATATE until the date of death
Up to approximately 11 years
Percentage of patients with treatment response
Time Frame: Up to approximately 11 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of patients with adverse events (AEs)
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in white blood cell (WBC) count
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in hemoglobin
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in absolute neutrophil count (ANC)
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in lymphocyte count
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in platelet count
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in alkaline phosphatase (ALP)
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in alanine aminotransferase (ALT)
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in aspartate aminotransferase (AST)
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in albumin
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in bilirubin
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in creatinine
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in estimated glomerular filtration rate (eGFR)
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in cromogranin A
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in pancreatic polypeptide
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Mean change from baseline in pancreastatin
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Number of patients who received other treatments prior to initial treatment with lutetium-177 DOTATATE
Time Frame: Prior to initial treatment with lutetium-177 DOTATATE
Prior to initial treatment with lutetium-177 DOTATATE
Number of patients who received lutetium-177 DOTATATE, categorized by number of doses
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Number of patients who received lutetium-177 DOTATATE, categorized by treatment stage
Time Frame: Up to approximately 11 years
Up to approximately 11 years
Quantity of lutetium-177 DOTATATE administered, categorized by treatment stage
Time Frame: Up to approximately 11 years
Up to approximately 11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CAAA601A1US08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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