Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
![]() |
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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03049189 |
Recruitment Status :
Active, not recruiting
First Posted : February 9, 2017
Last Update Posted : January 18, 2023
|
Sponsor:
ITM Solucin GmbH
Collaborators:
ABX CRO
PSI CRO
Information provided by (Responsible Party):
ITM Solucin GmbH
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | January 13, 2017 | ||||
First Posted Date ICMJE | February 9, 2017 | ||||
Last Update Posted Date | January 18, 2023 | ||||
Actual Study Start Date ICMJE | February 2, 2017 | ||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
progression-free survival (PFS) [ Time Frame: 12 weeks +/- 14 days, up to 30 months ] PFS will be assessed individually per patient from date of randomization until the date of first documented progression, assessed up to 30 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days
|
||||
Original Primary Outcome Measures ICMJE |
progression-free survival (PFS) [ Time Frame: 12 weeks +/- 14 days, up to 24 months ] PFS will be assessed individually per patient from date of randomization until the date of first documented progression, assessed up to 24 months, primary outcome will be measured by CT/MRI every 12 weeks +/- 14 days
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
overall survival (OS) [ Time Frame: every 3 months for a period of at least 30 months ] OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first
|
||||
Original Secondary Outcome Measures ICMJE |
overall survival (OS) [ Time Frame: every 3 months for a period of at least 24 months ] OS as secondary outcome measure will be assessed per patient from date of randomization until the date of death, whichever came first
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients | ||||
Official Title ICMJE | A Prospective, Randomised, Controlled, Open-label, Multicentre Phase III Study to Evaluate Efficacy and Safety of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Targeted Molecular Therapy With Everolimus in Patients With Inoperable, Progressive, Somatostatin Receptor-positive (SSTR+), Neuroendocrine Tumours of Gastroenteric or Pancreatic Origin (GEP-NET) | ||||
Brief Summary | The purpose of the study is to evaluate efficacy and safety of Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-Edotreotide compared to targeted molecular therapy with Everolimus in patients with inoperable, progressive, somatostatin receptor-positive (SSTR+), neuroendocrine tumours of gastroenteric or pancreatic origin (GEP-NET). | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
Condition ICMJE | Neuroendocrine Tumors | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
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 ICMJE | Active, not recruiting | ||||
Actual Enrollment ICMJE |
309 | ||||
Original Estimated Enrollment ICMJE |
300 | ||||
Estimated Study Completion Date ICMJE | June 2029 | ||||
Estimated Primary Completion Date | June 2024 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Austria, Belgium, Czechia, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, Switzerland, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03049189 | ||||
Other Study ID Numbers ICMJE | ITM-LET-01 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | ITM Solucin GmbH | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | ITM Solucin GmbH | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
|
||||
Investigators ICMJE | Not Provided | ||||
PRS Account | ITM Solucin GmbH | ||||
Verification Date | June 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |