Efficacy and Safety of 177Lu-edotreotide PRRT in GEP-NET Patients (COMPETE)
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ClinicalTrials.gov Identifier: NCT03049189 |
Recruitment Status :
Recruiting
First Posted : February 9, 2017
Last Update Posted : December 10, 2020
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Sponsor:
ITM Solucin GmbH
Collaborators:
ABX CRO
PSI CRO AG
Information provided by (Responsible Party):
ITM Solucin GmbH
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 13, 2017 | ||||||||
First Posted Date ICMJE | February 9, 2017 | ||||||||
Last Update Posted Date | December 10, 2020 | ||||||||
Actual Study Start Date ICMJE | February 2, 2017 | ||||||||
Estimated Primary Completion Date | December 2023 (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 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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current 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
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
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 |
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Condition ICMJE | Neuroendocrine Tumors | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
300 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 2024 | ||||||||
Estimated Primary Completion Date | December 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, Austria, 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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | ITM Solucin GmbH | ||||||||
Study Sponsor ICMJE | ITM Solucin GmbH | ||||||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||||||
PRS Account | ITM Solucin GmbH | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |