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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). 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.
Primary Outcome
MTD is the dose level at which no more than 1 of up to 6 patients experience dose limiting toxicity (DLT) during 1 cycle of treatment (42 days from the time the intended dose of metformin is reached for a given dose level), and the dose below that at which at least 2 (of ≤6) patients have DLT as a result of the experimental regimen. A DLT is defined as grade III or greater diarrhea leading to hospitalization or lasting \> 48 hours despite optimal anti-diarrheal medication; grade IV diarrhea desp
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 |
Why NCT02495103 stopped before completion
NCT02495103 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Metformin is the first listed.
NCT02495103 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02495103's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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