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NCT01100944 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT01100944: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01100944 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01100944, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: * Tumors of the thymus are rare and can be treated with surgery, but it is often difficult to determine whether a thymic tumor is malignant based on biopsy alone and the long-term survival rate is less than 50 percent. Because thymic tumors are so rare, most treatment knowledge comes from a relatively small series of cases, and the choice of treatment usually depends on the hospital or clinic staff's experience and familiarity with a given chemotherapy and surgery regimen. * Belinostat is an investigational anticancer drug that has not yet been approved by the Food and Drug Administration for use in any cancer. Researchers are interested in determining whether belinostat can be combined with conventional chemotherapy to safely and effectively treat advanced thymic cancer. Objectives: * To determine a safe and tolerable dose of belinostat that can be given in combination with cisplatin, doxorubicin, and cyclophosphamide. * To determine if belinostat (combined with the abovementioned standard chemotherapy regimen) is effective against thymic cancer cells. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with advanced or recurrent thymic malignancy that is not considered to be curable with surgery or radiation therapy, and who have not received previous chemotherapy treatment. Design: * Participants will be screened with a physical exam, blood tests, and imaging studies as directed by the study researchers. * Participants will receive six 21-day cycles (18 weeks) of treatment with belinostat in combination with cisplatin, doxorubicin, and cyclophosphamide. The treatment will require continuous infusion over 3 days, and participants will remain in the treatment center during this time. Participants will have regular blood tests, clinic visits, and imaging studies during the treatment period. * Participants who complete the six treatment cycles with no severe side effects may be offered the option to continue treatment with
Interventions
- DRUG PXD101with cisplatin+doxorubicin+cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2010-03-04 |
| Est. Completion | 2015-10-21 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01100944
The ClinicalTrials.gov registry entry for NCT01100944 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 26 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 PXD101with cisplatin+doxorubicin+cyclophosphamide is the first listed.
NCT01100944 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01100944 about?
NCT01100944 is a clinical study titled "A Phase 1/2 Study of PXD101 (Belinostat) in Combination With Cisplatin, Doxorubicin and Cyclophosphamide in the First Line Treatment of Advanced or Recurrent Thymic, Malignancies". Background: * Tumors of the thymus are rare and can be treated with surgery, but it is often difficult to determine whether a thymic tumor is malignant based on biopsy alone and the long-term survival rate is less than 50 percent. Because thymic tumors are so rare, most treatment knowledge comes fr...
What is the current status of trial NCT01100944?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2010-03-04. Estimated completion is 2015-10-21.
What interventions are being tested in trial NCT01100944?
The interventions under investigation include: PXD101with cisplatin+doxorubicin+cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT01100944?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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