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NCT01024387 · ClinicalTrials.gov registry record · Phase 2
AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors
A Phase 2 study of Carcinoid Tumor and Pancreatic Neuroendocrine Tumor, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 3
- Study locations
NCT01024387: Completed Phase 2 study of Carcinoid Tumor and Pancreatic Neuroendocrine Tumor, sponsored by Dana-Farber Cancer Institute.
NCT01024387 is a Phase 2 study of Carcinoid Tumor and Pancreatic Neuroendocrine Tumor that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 60 participants, below the 91-participant average among 8 other Carcinoid Tumor trials with a reported enrollment target (34% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01024387, a Phase 2 study of Carcinoid Tumor and Pancreatic Neuroendocrine Tumor, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this research study is to determine the effectiveness of AMG 479 against carcinoid and pancreatic neuroendocrine tumors. AMG 479 is an antibody that is made in the laboratory. Antibodies are highly specific proteins produced by the body's immune system that recognize foreign substances in the body. AMG 479 has been used in other research studies and information from those other research studies suggests that AMG 479 may help to prevent the growth of some neuroendocrine tumors. The observed antitumor activity of AMG 479, together with the current limited treatment options available for patients with neuroendocrine tumors, warrant further investigation of AMG 479 in this patient population.
Primary Outcome
Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better o
Conditions Studied
Interventions
- DRUG AMG 479
Study Locations (3)
Massachusetts
- Massachusetts General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Florida
- H. Lee Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2010-03 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT01024387 record still lists
NCT01024387 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 91-participant average among 8 other Carcinoid Tumor trials with a reported enrollment target (34% lower).
The record links to 3 conditions, with Carcinoid Tumor appearing as the primary indexed condition, and to 1 intervention - of which AMG 479 is the first listed.
NCT01024387 reports a single indexed study location in Massachusetts, Florida.
Frequently Asked Questions
What is clinical trial NCT01024387 about?
NCT01024387 is a clinical study titled "AMG 479 in Advanced Carcinoid and Pancreatic Neuroendocrine Tumors". The purpose of this research study is to determine the effectiveness of AMG 479 against carcinoid and pancreatic neuroendocrine tumors. AMG 479 is an antibody that is made in the laboratory. Antibodies are highly specific proteins produced by the body's immune system that recognize foreign substance...
What is the current status of trial NCT01024387?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2010-03. Estimated completion is 2017-01.
What conditions does trial NCT01024387 study?
This clinical trial studies the following conditions: Carcinoid Tumor, Pancreatic Neuroendocrine Tumor, Neuroendocrine Tumor.
What interventions are being tested in trial NCT01024387?
The interventions under investigation include: AMG 479 (DRUG).
Who is sponsoring clinical trial NCT01024387?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01024387 being conducted?
This trial has 3 study locations across Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01024387's enrollment target sits among peer trials
60 5th of 8 higher than 4 of 8 other Carcinoid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoid Tumor 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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