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NCT00589290 · ClinicalTrials.gov registry record · Phase 2
Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00589290: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00589290 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00589290, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
Background: * Cisplatin-containing chemotherapy is the standard treatment for advanced tumors of the thymus that cannot be removed surgically. * New treatment options are needed for patients with advanced tumors of the thymus that do not improve with cisplatin-containing therapy. * Belinostat is a drug that inhibits enzymes called histone deacetylase. Histone deacetylase inhibitors have shown promising activity in many cancers and may be useful in treating patients with thymic tumors. Objectives: -To assess the safety and effectiveness of belinostat for treatment of malignant thymic tumors in patients who failed after standard treatment. Eligibility: -Patients 18 years of age or older with an advanced thymic tumor that has progressed after treatment with platinum-containing chemotherapy. Design: * Patients receive belinostat treatment in 21-day cycles. The drug is given as an infusion through a vein during days 1 through 5 of each cycle. Treatment cycles continue as long as the medicine is tolerated and the cancer does not worsen. * Patients have a physical examination and several blood tests during every cycle. * Patients have an electrocardiogram every cycle before starting the belinostat infusion and again on the last day of the infusion. * Patients undergo computed tomography (CT) or other imaging test, such as ultrasound or MRI, every two cycles to evaluate the response of the tumor to treatment. * Tumor tissue obtained from a previous biopsy is used for research purposes.
Interventions
- DRUG Belinostat (PDX101)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2007-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00589290
The ClinicalTrials.gov registry entry for NCT00589290 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 41 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 Belinostat (PDX101) is the first listed.
NCT00589290 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00589290 about?
NCT00589290 is a clinical study titled "Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage". Background: * Cisplatin-containing chemotherapy is the standard treatment for advanced tumors of the thymus that cannot be removed surgically. * New treatment options are needed for patients with advanced tumors of the thymus that do not improve with cisplatin-containing therapy. * Belinostat is a ...
What is the current status of trial NCT00589290?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2007-12. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00589290?
The interventions under investigation include: Belinostat (PDX101) (DRUG).
Who is sponsoring clinical trial NCT00589290?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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