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NCT00006155 · ClinicalTrials.gov registry record · Phase 1
SU5416 and Carboplatin to Treat Ovarian Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
NCT00006155: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00006155 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00006155, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
Study Summary
SU5416, a novel antiangiogenesis agent, has been shown to be a potent and selective inhibitor of the tyrosine kinase activity of FlK-1 (a downstream effector of VEGF) in vitro and to inhibit the growth of endothelial cells. Since VEGF mRNA levels and vessel counts in tumor tissues have been shown to be inversely related to prognosis in ovarian cancer, SU5416 may prove to be a useful agent in this disease. Platinum agents currently provide the most effective treatment for ovarian cancer. However, ovarian cancer often becomes refractory to platinum therapy, leaving the patient with a poor prognosis. This is a phase I study designed to: a) determine a dose level of carboplatin to use in combination with an established dose of SU5416 for treatment of patients with platinum-refractory ovarian cancer, b) assess the side effect profile of SU5416 and carboplatin combination therapy, c) characterize any alterations in SU5416 pharmacokinetic and pharmacodynamic parameters when given in combination with carboplatin, d) characterize carboplatin pharmacokinetic and pharmacodynamic parameters when given in combination with SU5416, e) do exploratory studies to assess the effect of SU5416 on platinum-DNA adduct levels, f) do exploratory studies to assess any alterations in ERCC1 mRNA levels when carboplatin is administered with SU5416, and g) obtain preliminary evidence of the ability of SU5416 to reverse platinum resistance in patients with platinum-refractory ovarian carcinoma.
Interventions
- DRUG SU5416 and carboplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2000-08 |
| Est. Completion | 2001-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006155
The ClinicalTrials.gov registry entry for NCT00006155 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 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 1 intervention - of which SU5416 and carboplatin is the first listed.
NCT00006155 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00006155 about?
NCT00006155 is a clinical study titled "SU5416 and Carboplatin to Treat Ovarian Cancer". SU5416, a novel antiangiogenesis agent, has been shown to be a potent and selective inhibitor of the tyrosine kinase activity of FlK-1 (a downstream effector of VEGF) in vitro and to inhibit the growth of endothelial cells. Since VEGF mRNA levels and vessel counts in tumor tissues have been shown to...
What is the current status of trial NCT00006155?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2000-08. Estimated completion is 2001-04.
What interventions are being tested in trial NCT00006155?
The interventions under investigation include: SU5416 and carboplatin (DRUG).
Who is sponsoring clinical trial NCT00006155?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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