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NCT02315625 · ClinicalTrials.gov registry record · Phase 2
Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT02315625: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT02315625 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02315625, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
Background: \- Neuroendocrine tumors (NETs) come from cells of the hormonal and nervous systems. Some people have surgery to shrink the tumor. Sometimes the tumors come back. Researchers think that treatment with drugs based on knowing the defective gene might give better results. Objective: \- To see if drugs selected based on the defective gene result in better tumor response. The drugs are Sunitinib and Everolimus. Eligibility: \- People age 18 and older with an advanced low- or intermediate-grade gastrointestinal or pancreatic neuroendocrine tumor. Design: * Participants will be screened with: * Medical history * Physical exam * Scans * Blood, urine, and lab tests * The study team will see if participants should have surgery. * If yes, participants will: * Sign a separate consent * Have computed tomography (CT) scan before and after surgery * Have as much of the tumor removed as possible. A small piece will be tested for mutation type. * If no, participants will have a small piece of tumor removed for the testing. * If the surgery might cure them, the participant will leave the study. The other participants will be assigned to take either Sunitinib or Everolimus. * Participants will take their drug by mouth once a day. They will keep a medicine diary. Some will keep track of their blood pressure at least weekly. * Screening tests may be repeated at study visits. Participants also may have their heart evaluated. * About 30 days after the last day of their study drug, participants will have a follow-up visit that repeats the screening tests. * Participants will be contacted every 3 months after this visit.
Primary Outcome
Median amount of time subject survives without disease progression after treatment. Progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or
Interventions
- DRUG Everolimus
- DRUG Sunitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2015-04-08 |
| Est. Completion | 2019-05-22 |
| Phase | Phase 2 |
Why NCT02315625 stopped before completion
NCT02315625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT02315625 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02315625 about?
NCT02315625 is a clinical study titled "Study of Mutation-Targeted Therapy With Sunitinib or Everolimus in People With Advanced Low- or Intermediate-Grade Neuroendocrine Tumors of the Gastrointestinal Tract and Pancreas With or Without Cytoreductive Surgery". Background: \- Neuroendocrine tumors (NETs) come from cells of the hormonal and nervous systems. Some people have surgery to shrink the tumor. Sometimes the tumors come back. Researchers think that treatment with drugs based on knowing the defective gene might give better results. Objective: \- T...
What is the current status of trial NCT02315625?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2015-04-08. Estimated completion is 2019-05-22.
What interventions are being tested in trial NCT02315625?
The interventions under investigation include: Everolimus (DRUG), Sunitinib (DRUG).
Who is sponsoring clinical trial NCT02315625?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02315625's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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