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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: Completed Phase 1 study of Neuroendocrine Tumors, sponsored by Emory University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Determine the maximum tolerated dose of pasireotide and everolimus that can be administered with SIR spheres. Patients will be treated in cohorts of three. Dose of everolimus will be increased after every three patients. Plan is to determine the maximum dose that can be administered with less than 2 out of 6 patients develop significant side effects.
Conditions Studied
Interventions
- DRUG Everolimus
- DRUG Pasireotide
- PROCEDURE Sir-sphere Radioembolization
Study Locations (1)
Georgia
- Emory University Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-12 |
| Est. Completion | 2018-10 |
| Phase | Phase 1 |
What the finished NCT01469572 record still lists
NCT01469572 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 180-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT01469572's enrollment target sits among peer trials
13 47th of 52 higher than 6 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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