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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02315625
The ClinicalTrials.gov registry entry for NCT02315625 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT02315625 reports 0 study locations.
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.
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