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NCT01372813 · ClinicalTrials.gov registry record · Phase 2
Vandetanib to Treat Advanced Kidney Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT01372813: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01372813 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01372813, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
Background: * One way tumors are able to grow is by forming new blood vessels that supply it with nutrients and oxygen. * Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels. * Blocking these proteins may prevent the tumor cells or blood vessels from continuing to grow. Objectives: * To determine whether vandetanib can cause tumors to shrink or stabilize in patients with advanced kidney cancer. * To determine how vandetanib may work in people with kidney cancer and to develop tests that may be helpful in studying kidney cancer. Eligibility: -Patients 18 years of age or older with advanced clear cell kidney cancer whose disease has worsened after treatment with one or more of the following drugs: sunitinib, sorafenib, interleukin-2 and temsirolimus; or patients who have had to stop treatment with these drugs due to unacceptable side effects; or patients who are unable to receive standard treatment. Design: * Patients take a vandetanib pill once a day in 28-day cycles. * Patients are followed in the clinic every 2 weeks during the first month of treatment and then every 4 weeks for a physical examination, blood and urine tests, electrocardiogram and a review of any drug side effects. * Patients have imaging scans (computed tomography (CT) or magnetic resonance imaging (MRI)) about every 8 weeks to monitor tumor growth. MRI scans are also done to look at tumor blood flow when treatment begins, 24 hours after the first dose of treatment, and again about 4 and 8 weeks after starting treatment * Optional tumor biopsies (surgical removal of a sample of tumor tissue) may be done before starting vandetanib treatment and after 4 weeks of treatment to look for drug effects on the tumor.
Primary Outcome
Clinical response is the best response recorded from the start of treatment until disease progression. Clinical response is assessed by the Response Evaluation in Solid Tumors (RECIST) criteria. A partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as a reference the baseline sum LD. A complete response (CR) is the disappearance of all target lesions.
Interventions
- DRUG vandetanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-06 |
| Phase | Phase 2 |
Why NCT01372813 stopped before completion
NCT01372813 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which vandetanib is the first listed.
NCT01372813 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01372813 about?
NCT01372813 is a clinical study titled "Vandetanib to Treat Advanced Kidney Cancer". Background: * One way tumors are able to grow is by forming new blood vessels that supply it with nutrients and oxygen. * Vandetanib (ZD6474) is an experimental drug that blocks certain proteins on the surface of tumor and blood vessel cells that are involved with the formation of new blood vessels...
What is the current status of trial NCT01372813?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2007-12. Estimated completion is 2010-06.
What interventions are being tested in trial NCT01372813?
The interventions under investigation include: vandetanib (DRUG).
Who is sponsoring clinical trial NCT01372813?
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 NCT01372813's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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