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NCT00923247 · ClinicalTrials.gov registry record · Phase 1
A Targeted Phase I/II Trial of ZD6474 (Vandetanib; ZACTIMA) Plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults With Solid Tumors With a Focus on Hereditary or Sporadic, Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC)
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00923247: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00923247 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 22 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00923247, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Background: * The combination of anti-cancer drugs vandetanib (given orally) and bortezomib (given intravenously) has not been used in humans. However, both drugs have been studied separately. Bortezomib has been approved by the U.S. Food and Drug Administration (FDA) for treating multiple myeloma and mantle cell lymphoma, while vandetanib is still under investigation pending FDA approval. * Both bortezomib and vandetanib are under investigation for use in treating certain kinds of cancer. Researchers hope that the combination of these two drugs will be more effective than either of them alone. Objectives: * To determine if the combination of vandetanib and bortezomib will decrease the amount of the cancer and, if it does, to determine how long the response will last. * To determine any side effects that may occur with this combination of treatments. * To determine what doses of each drug are well tolerated and safe when given together. * To study genetic mutations in tumors to better understand how tumors grow and how these drugs interact with the tumor. Eligibility: * Patients 18 years of age and older with solid tumors that cannot be surgically removed and have either recurred or shown further growth. The tumor(s) must be able to be evaluated by X-ray, MRI (magnetic resonance imaging), and CT (computerized tomography) scanning. * Patients who have been diagnosed with medullary thyroid cancer will participate in Phase II of the study. Design: * Tumor samples may be taken at the start of the study for research purposes. * Phase I: Patient groups will be treated on an outpatient basis with vandetanib and bortezomib, given at increasing doses over four different levels to determine the maximum tolerated dose calculated by height and weight: * Doses will be given on Days 1, 4, 8, and 11 for each 28-day cycle. * Two additional levels (Level 1A and Level 1B) may be included in the study, depending on side effects at various levels. * Phase II: Patients with medul
Interventions
- DRUG Bortezomib
- DRUG Vandetanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2009-02-19 |
| Est. Completion | 2016-12-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00923247
The ClinicalTrials.gov registry entry for NCT00923247 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 22 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 Bortezomib is the first listed.
NCT00923247 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00923247 about?
NCT00923247 is a clinical study titled "A Targeted Phase I/II Trial of ZD6474 (Vandetanib; ZACTIMA) Plus the Proteasome Inhibitor, Bortezomib (Velcade ), in Adults With Solid Tumors With a Focus on Hereditary or Sporadic, Locally Advanced or Metastatic Medullary Thyroid Cancer (MTC)". Background: * The combination of anti-cancer drugs vandetanib (given orally) and bortezomib (given intravenously) has not been used in humans. However, both drugs have been studied separately. Bortezomib has been approved by the U.S. Food and Drug Administration (FDA) for treating multiple myeloma ...
What is the current status of trial NCT00923247?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2009-02-19. Estimated completion is 2016-12-09.
What interventions are being tested in trial NCT00923247?
The interventions under investigation include: Bortezomib (DRUG), Vandetanib (DRUG).
Who is sponsoring clinical trial NCT00923247?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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