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NCT02683941 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours
A Phase 3 study, sponsored by Ipsen.
- Terminated
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT02683941 is a Phase 3 study that was terminated before completion, run by Ipsen. The registered enrollment target is 77 participants.
The verdict
NCT02683941, a Phase 3 study, was terminated before completion, sponsored by Ipsen.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study Summary
This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs. This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period. The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours. Recent updates of National Cancer Institute Cancer Network (NCCN) \& European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5. The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.
Interventions
- DRUG Placebo
- DRUG Lanreotide (Autogel formulation)
- DRUG Best Supportive Care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2017-03-06 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02683941
The ClinicalTrials.gov registry entry for NCT02683941 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02683941 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02683941 about?
NCT02683941 is a clinical study titled "Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours". This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs. This study contains two phase...
What is the current status of trial NCT02683941?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2017-03-06. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT02683941?
The interventions under investigation include: Placebo (DRUG), Lanreotide (Autogel formulation) (DRUG), Best Supportive Care (DRUG).
Who is sponsoring clinical trial NCT02683941?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
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