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NCT00910000 · ClinicalTrials.gov registry record · Phase 1
Vorinostat, Carboplatin and Gemcitabine in Women With Recurrent, Platinum-Sensitive Ovarian Cancer
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT00910000 is a Phase 1 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 15 participants.
The verdict
NCT00910000, a Phase 1 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
This trial is a Phase Ib/II study of carboplatin/gemcitabine/vorinostat for the treatment of platinum sensitive recurrent ovarian cancer. The carboplatin and gemcitabine combination is an FDA approved regimen for platinum-sensitive recurrent ovarian cancer. Vorinostat is a type of drug called a histone deacetylase inhibitor (HDAC inhibitor). HDAC inhibitors interact with chromosomes in the cancer cell and cause cancer cells to stop growing. Vorinostat has shown a decrease in the amount of ovarian cancer cells growing in the laboratory and also may enhance the anti-cancer effects of carboplatin.The purpose of the Phase Ib study is to determine the highest dose of the drug vorinostat that can be given safely in combination with carboplatin and gemcitabine. Not everyone who participates in this research study will receive the same dose of the study drug, vorinostat, but carboplatin and gemcitabine doses are held constant. Vorinostat doses depend on previous enrollment and tolerability. The expansion Phase II study uses the vorinostat dose found in the Phase Ib study in combination with carboplatin/gemcitabine and as a single agent maintenance therapy to better understand toxicity and efficacy.
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2009-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00910000
The ClinicalTrials.gov registry entry for NCT00910000 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT00910000 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00910000 about?
NCT00910000 is a clinical study titled "Vorinostat, Carboplatin and Gemcitabine in Women With Recurrent, Platinum-Sensitive Ovarian Cancer". This trial is a Phase Ib/II study of carboplatin/gemcitabine/vorinostat for the treatment of platinum sensitive recurrent ovarian cancer. The carboplatin and gemcitabine combination is an FDA approved regimen for platinum-sensitive recurrent ovarian cancer. Vorinostat is a type of drug called a hist...
What is the current status of trial NCT00910000?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2009-06. Estimated completion is 2015-10.
What interventions are being tested in trial NCT00910000?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT00910000?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
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