Condition or disease | Intervention/treatment | Phase |
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Gastro-enteropancreatic Neuroendocrine Tumor | Drug: Lutathera Drug: long-acting octreotide Drug: high dose long-acting octreotide | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 222 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET |
Actual Study Start Date : | January 22, 2020 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2026 |
Arm | Intervention/treatment |
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Experimental: Lutathera plus long-acting octreotide |
Drug: Lutathera
7.4 GBq/200 mCi x 4 administrations every 8 +/- 1 weeks
Drug: long-acting octreotide 30 mg every 8 weeks during Lutathera treatment and every 4 weeks after last Lutathera treatment
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Active Comparator: high dose long-acting octreotide |
Drug: high dose long-acting octreotide
60 mg every 4 weeks
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Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Novartis Pharmaceuticals | 1-888-669-6682 | novarits.email@novartis.com | |
Contact: Novartis Pharmaceuticals | +41613241111 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 24, 2019 | ||||||||
First Posted Date ICMJE | June 3, 2019 | ||||||||
Last Update Posted Date | April 1, 2021 | ||||||||
Actual Study Start Date ICMJE | January 22, 2020 | ||||||||
Estimated Primary Completion Date | December 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS) [ Time Frame: through Week 72 until 99 PFS events are reached ] Time from randomization to the first line progression (centrally assessed according to RECIST 1.1)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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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 | Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET | ||||||||
Official Title ICMJE | A Phase III Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET | ||||||||
Brief Summary | The aim of NETTER-2 is to determine if Lutathera in combination with long-acting octreotide prolongs PFS in GEP-NET patients with high proliferation rate tumors (G2 and G3), when given as a first line treatment compared to treatment with high dose (60 mg) long-acting octreotide. Somatostatin analog (SSA) naive patients are eligible, as well as patients previously treated with SSAs in the absence of progression. | ||||||||
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 | Gastro-enteropancreatic Neuroendocrine Tumor | ||||||||
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 |
222 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2026 | ||||||||
Estimated Primary Completion Date | December 31, 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 | 15 Years and older (Child, Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, France, Italy, Korea, Republic of, Netherlands, Spain, United Kingdom, United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03972488 | ||||||||
Other Study ID Numbers ICMJE | CAAA601A22301 2019-001562-15 ( EudraCT Number ) |
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Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Advanced Accelerator Applications | ||||||||
Study Sponsor ICMJE | Advanced Accelerator Applications | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Advanced Accelerator Applications | ||||||||
Verification Date | March 2021 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |