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NCT02495103 · ClinicalTrials.gov registry record · Phase 1
Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02495103: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT02495103 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02495103, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: \- There are no established treatments for people with certain advanced kidney cancers. These tumors often don't respond well to currently available treatments. Researchers believe that two drugs that treat other diseases metformin and vandetanib could help people with advanced kidney cancer. Objective: \- To test the combination of metformin and vandetanib in people with advanced kidney cancer. Phase I of the study will determine a safe dose for the drugs. Phase II will test this dose in people with certain kidney cancers. Eligibility: * For Phase I, people 18 and over with advanced kidney cancer * For Phase II, people 18 and over with advanced hereditary leiomyomatosis and renal cell cancer (HLRCC), succinate dehydrogenase renal cell carcinoma (SDH-RCC), or advanced papillary renal cell carcinoma not related to a hereditary syndrome Design: * The study will last many months. * Participants will be screened with medical history and physical exam. * Participants will take the study drugs by mouth every day. * Participants will measure and record their blood pressure every day. * Participants will have many tests: * Blood and urine tests * Magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET) scan, and other imaging tests: they will lie in machines that take pictures of their body. * Electrocardiogram (ECG): soft electrodes will be stuck to the skin. A machine will record the hearts signals. * Bone scan * Some participants may have a gynecology evaluation or photos of skin tumors taken. * Participants will have an optional tumor biopsy. * After they stop taking the drugs, participants may have medical history, physical exam, and blood tests. They will be contacted once a year by phone to find out how they are doing.
Interventions
- DRUG Metformin
- DRUG Vandetanib
- DRUG Vandetanib/Metformin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2015-08-26 |
| Est. Completion | 2020-02-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02495103
The ClinicalTrials.gov registry entry for NCT02495103 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 7 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 3 interventions - of which Metformin is the first listed.
NCT02495103 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02495103 about?
NCT02495103 is a clinical study titled "Vandetanib in Combination With Metformin in People With HLRCC or SDH-Associated Kidney Cancer or Sporadic Papillary Renal Cell Carcinoma". Background: \- There are no established treatments for people with certain advanced kidney cancers. These tumors often don't respond well to currently available treatments. Researchers believe that two drugs that treat other diseases metformin and vandetanib could help people with advanced kidney c...
What is the current status of trial NCT02495103?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2015-08-26. Estimated completion is 2020-02-06.
What interventions are being tested in trial NCT02495103?
The interventions under investigation include: Metformin (DRUG), Vandetanib (DRUG), Vandetanib/Metformin (DRUG).
Who is sponsoring clinical trial NCT02495103?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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