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NCT01578239 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours
A Phase 3 study, sponsored by Advanced Accelerator Applications.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
NCT01578239 is a Phase 3 study that has completed, run by Advanced Accelerator Applications. The registered enrollment target is 231 participants.
The verdict
NCT01578239, a Phase 3 study, has completed, sponsored by Advanced Accelerator Applications.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
Study Summary
This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, inoperable, somatostatin receptor positive, histologically proven midgut carcinoid tumours with progression despite LAR treatment.
Interventions
- DRUG Octreotide LAR
- DRUG 177Lu-DOTA0-Tyr3-Octreotate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2012-09-06 |
| Est. Completion | 2021-01-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01578239
The ClinicalTrials.gov registry entry for NCT01578239 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanced Accelerator Applications, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Octreotide LAR is the first listed.
NCT01578239 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01578239 about?
NCT01578239 is a clinical study titled "A Study Comparing Treatment With 177Lu-DOTA0-Tyr3-Octreotate to Octreotide LAR in Patients With Inoperable, Progressive, Somatostatin Receptor Positive Midgut Carcinoid Tumours". This was a multicenter, stratified, open, randomized, comparator-controlled, parallel-group phase III study comparing treatment with Lutathera plus best supportive care (30 mg Octreotide LAR) to treatment with high dose (60 mg) Octreotide LAR in participants with metastasized or locally advanced, in...
What is the current status of trial NCT01578239?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2012-09-06. Estimated completion is 2021-01-18.
What interventions are being tested in trial NCT01578239?
The interventions under investigation include: Octreotide LAR (DRUG), 177Lu-DOTA0-Tyr3-Octreotate (DRUG).
Who is sponsoring clinical trial NCT01578239?
This trial is sponsored by Advanced Accelerator Applications, which has 8 total clinical trials registered on ClinicalTrials.gov.
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