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NCT02399215 · ClinicalTrials.gov registry record · Phase 2
Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
A Phase 2 study of Carcinoid Tumor and Neuroendocrine Neoplasm, sponsored by Roswell Park Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT02399215: Completed Phase 2 study of Carcinoid Tumor and Neuroendocrine Neoplasm, sponsored by Roswell Park Cancer Institute.
NCT02399215 is a Phase 2 study of Carcinoid Tumor and Neuroendocrine Neoplasm that has completed, run by Roswell Park Cancer Institute. The registered enrollment target is 32 participants, below the 95-participant average among 8 other Carcinoid Tumor trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02399215, a Phase 2 study of Carcinoid Tumor and Neuroendocrine Neoplasm, has completed, sponsored by Roswell Park Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well nintedanib works in treating patients with neuroendocrine tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or have spread from the primary site (place where they started) to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by slowing or stopping a certain type of receptor called vascular endothelial growth factor receptor (VEGFR) from attaching to its target. This may stop the growth of neuroendocrine tumors by blocking the growth of new blood vessels necessary for tumor growth.
Primary Outcome
Will be reported using standard Kaplan-Meier methods. Ninety percent confidence intervals for the median PFS will be calculated using Greenwood's formula. Additionally, a confidence interval for the 16-week PFS rate will be obtained using Jeffrey's prior method. The association between survival and quantified variables will be investigated using the Cox-proportional hazard model.
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Nintedanib
- OTHER Pharmacological Study
Study Locations (2)
New York
- Roswell Park Cancer Institute - Buffalo
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2015-05-15 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 2 |
What the finished NCT02399215 record still lists
NCT02399215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 95-participant average among 8 other Carcinoid Tumor trials with a reported enrollment target (66% lower).
The record links to 3 conditions, with Carcinoid Tumor appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT02399215 reports a single indexed study location in New York, Ohio.
Frequently Asked Questions
What is clinical trial NCT02399215 about?
NCT02399215 is a clinical study titled "Nintedanib in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors". This phase II trial studies how well nintedanib works in treating patients with neuroendocrine tumors that have spread from where they started to nearby tissue or lymph nodes (locally advanced) or have spread from the primary site (place where they started) to other places in the body (metastatic). ...
What is the current status of trial NCT02399215?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 32 participants. The study started on 2015-05-15. Estimated completion is 2022-08-31.
What conditions does trial NCT02399215 study?
This clinical trial studies the following conditions: Carcinoid Tumor, Neuroendocrine Neoplasm, Metastatic Carcinoid Tumor.
What interventions are being tested in trial NCT02399215?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Nintedanib (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02399215?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02399215 being conducted?
This trial has 2 study locations across New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02399215's enrollment target sits among peer trials
32 6th of 8 higher than 3 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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