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NCT01469572 · ClinicalTrials.gov registry record · Phase 1

Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases

A Phase 1 study of Neuroendocrine Tumors, sponsored by Emory University.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target
1
Study location

NCT01469572 is a Phase 1 study of Neuroendocrine Tumors that has completed, run by Emory University. The registered enrollment target is 13 participants, below the 180-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01469572, a Phase 1 study of Neuroendocrine Tumors, has completed, sponsored by Emory University.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or radioembolization are considered "standard of care" regimens in patients with liver lesions from neuroendocrine tumors. However, the use of the combination of everolimus and radioembolization has not been formally evaluated in the setting of a clinical trial. Pasireotide is a medication that is intended to block the hormonal secretions from the neuroendocrine tumors. This study is divided into two parts. In the first part, the aim of the study is to determine the safety of combining everolimus, pasireotide, and radioembolization. For this part of the study the investigators will enroll up to 18 patients. After the investigators confirm the safety of the combination, they will conduct the second part of the study which will focus on evaluating the effectiveness of the combination. For this part of the study the investigators intend to enroll a total of 37 patients.

Conditions Studied

Neuroendocrine Tumors

Interventions

  • DRUG Everolimus
  • DRUG Pasireotide
  • PROCEDURE Sir-sphere Radioembolization

Study Locations (1)

Georgia

  • Emory University Winship Cancer Institute - Atlanta

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2011-12
Est. Completion 2018-10
Phase Phase 1

Sponsor

Emory University

1,208 total trials

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What the Registry Record Tells You About NCT01469572

The ClinicalTrials.gov registry entry for NCT01469572 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 180-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (93% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 3 interventions - of which Everolimus is the first listed.

NCT01469572 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.

Frequently Asked Questions

What is clinical trial NCT01469572 about?

NCT01469572 is a clinical study titled "Pasireotide, Everolimus and Selective Internal Radioembolization Therapy for Unresectable Hepatic Metastases". The purpose of this study is to see the safety and activity of using pasireotide, everolimus and radioembolization (Selective Internal Radioembolization Therapy-SIRT) in the treatment of neuroendocrine tumors (carcinoid) that has spread to the liver. Both everolimus or radioembolization are consider...

What is the current status of trial NCT01469572?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-12. Estimated completion is 2018-10.

What conditions does trial NCT01469572 study?

This clinical trial studies the following conditions: Neuroendocrine Tumors.

What interventions are being tested in trial NCT01469572?

The interventions under investigation include: Everolimus (DRUG), Pasireotide (DRUG), Sir-sphere Radioembolization (PROCEDURE).

Who is sponsoring clinical trial NCT01469572?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01469572 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.