A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours (NETTER-1)
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ClinicalTrials.gov Identifier: NCT01578239 |
Recruitment Status :
Completed
First Posted : April 16, 2012
Results First Posted : October 2, 2017
Last Update Posted : March 24, 2021
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Sponsor:
Advanced Accelerator Applications
Information provided by (Responsible Party):
Advanced Accelerator Applications
- Study Details
- Tabular View
- Study Results
- Disclaimer
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Carcinoid Tumor of the Small Bowel Neuroendocrine Tumour |
Interventions |
Drug: Octreotide LAR Drug: 177Lu-DOTA0-Tyr3-Octreotate |
Enrollment | 231 |
Participant Flow
Recruitment Details | Overall Study Table includes all subjects who were enrolled prior to the primary endpoint data cutoff when 74 events of progression free survival were reached (24 July 2015). |
Pre-assignment Details |
Arm/Group Title | 177Lu-DOTA0-Tyr3-Octreotate | Octreotide LAR |
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Cumulative dose of 29.6 GBq (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate delivered over 4 doses Dosing regimen: - 4 doses of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered in 8±1-week intervals. Intervals could be extended up to 16 weeks to accommodate resolving acute toxicity (see Dose Modifying Toxicity (DMT) below) - amino acids will be given with each administration for kidney protection; Patients experiencing clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, were given 30 mg Octreotide LAR s.c. rescue injections for symptom control purpose, unless the patient progresses or dies. | 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the patient progresses or dies (see Dose Modifying Toxicity (DMT)); In case patients experience clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections are allowed. |
Period Title: Overall Study | ||
Started [1] | 116 | 113 |
Safety Set (SAF) [2] | 112 | 111 |
Completed | 94 | 88 |
Not Completed | 22 | 25 |
[1]
All randomized patients at the efficacy cut-off date were included in Full Analysis dataset (FAS)
[2]
All patients who received/took trial medication who were randomized up to the safety cut-off date of 30 June 2016 were included in the Safety Set (SAF)
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Baseline Characteristics
Arm/Group Title | 177Lu-DOTA0-Tyr3-Octreotate | Octreotide LAR | Total | |
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Cumulative dose of 29.6 GBq (800 mCi) 177Lu-DOTA0-Tyr3-Octreotate delivered over 4 doses Dosing regimen: - 4 doses of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered in 8±1-week intervals. Intervals could be extended up to 16 weeks to accommodate resolving acute toxicity (see Dose Modifying Toxicity (DMT) below) - amino acids will be given with each administration for kidney protection; Patients experiencing clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, were given 30 mg Octreotide LAR s.c. rescue injections for symptom control purpose, unless the patient progresses or dies. | 60 mg Octreotide LAR treatment every 4 weeks (i.m. injections) until the end of the study, unless the patient progresses or dies (see Dose Modifying Toxicity (DMT)); In case patients experience clinical symptoms (i.e. diarrhoea and flushing) associated with their carcinoid tumours, s.c. Octreotide rescue injections are allowed. | Total of all reporting groups | |
Overall Number of Baseline Participants | 116 | 113 | 229 | |
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All patients who were randomized in the study.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 116 participants | 113 participants | 229 participants | |
63.3 (9.4) | 64.1 (9.7) | 63.7 (9.53) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 116 participants | 113 participants | 229 participants | |
Female |
53 45.7%
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60 53.1%
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113 49.3%
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Male |
63 54.3%
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53 46.9%
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116 50.7%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 116 participants | 113 participants | 229 participants |
Belgium | 4 | 2 | 6 | |
France | 12 | 9 | 21 | |
Germany | 10 | 7 | 17 | |
Italy | 5 | 9 | 14 | |
Portugal | 1 | 0 | 1 | |
Spain | 5 | 6 | 11 | |
United Kingdom | 13 | 11 | 24 | |
United States | 66 | 69 | 135 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis Pharmaceuticals |
Phone: | 862-778-8300 |
EMail: | Novartis.email@novartis.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Advanced Accelerator Applications |
ClinicalTrials.gov Identifier: | NCT01578239 |
Other Study ID Numbers: |
AAA-III-01 2011-005049-11 ( EudraCT Number ) CAAA601A12301 ( Other Identifier: Novartis ) |
First Submitted: | April 10, 2012 |
First Posted: | April 16, 2012 |
Results First Submitted: | August 29, 2017 |
Results First Posted: | October 2, 2017 |
Last Update Posted: | March 24, 2021 |