Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 231 participants
Start Date 2012-09-06
Est. Completion 2021-01-18
Phase Phase 3

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.