CLINICAL TRIALS PROFILE FOR BELEODAQ
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All Clinical Trials for Beleodaq
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00301756 ↗ | Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors | Completed | National Cancer Institute (NCI) | Phase 2 | 2006-09-01 | This phase II trial studies how well belinostat works in treating patients with ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer that have spread to other places in the body or ovarian low malignant potential tumors. Belinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. |
| NCT00334789 ↗ | Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery | Completed | National Cancer Institute (NCI) | Phase 1 | 2006-06-12 | This phase I trial is studying the side effects and best dose of belinostat when given together with isotretinoin in treating patients with metastatic or unresectable solid tumors. Belinostat may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Isotretinoin may cause solid tumor cells to look more like normal cells, and to grow and spread more slowly. Giving belinostat together with isotretinoin may be an effective treatment for metastatic or unresectable solid tumors. |
| NCT00351975 ↗ | Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases | Completed | National Cancer Institute (NCI) | Phase 1 | 2006-06-01 | This phase I trial is studying the side effects and best dose of belinostat when given together with azacitidine in treating patients with advanced hematologic cancers or other diseases. Belinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving belinostat together with azacitidine may kill more cancer cells. |
| NCT01273155 ↗ | Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction | Completed | National Cancer Institute (NCI) | Phase 1 | 2011-01-10 | Background: - Belinostat is an experimental cancer treatment drug that works by helping to turn on genes that limit cell growth and survival of cancer cells. These genes are often switched off in tumors. Belinostat has been given to patients with different types of cancer to measure its safety and effectiveness, but it has not been given in a formal trial to cancer patients who have abnormal liver function. Because belinostat is processed by the liver, its safety and effectiveness needs to be established in individuals who have abnormal liver function. Researchers are interested in comparing the effects of belinostat as a cancer treatment drug in individuals with normal and abnormal liver function. Objectives: - To test the safety and effectiveness of belinostat in individuals who have solid tumors and lymphomas and who also have abnormal liver function. - To compare the results of belinostat treatment in individuals with normal and abnormal liver function. Eligibility: - Individuals at least 18 years of age who have been diagnosed with solid tumors or lymphomas that have not responded to standard treatment. - Individuals with normal liver function and varying degrees of abnormal liver function (mild, moderate, severe) are eligible. Design: - Participants will be screened with a full medical history and physical examination, as well as blood and urine tests, and tumor imaging studies. Participants will then be divided into study groups based on their liver function. - Participants will receive belinostat in cycles of treatment. Except for cycle 1, all cycles will last 21 days. Cycle 1 will last 28 days. For cycle 1 only, participants will receive a single dose of belinostat 1 week before the regular 21-day treatment cycle starts. - In each cycle, participants will receive belinostat once a day for 5 days, and will be asked to keep a medication diary to record any side effects. - Participants will have regular clinic visits with blood and urine sample collection and imaging studies to evaluate the cancer's response to treatment. - Participants may continue to take belinostat for as long as the cancer responds to the treatment. |
| NCT01583777 ↗ | Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer | Completed | Acrotech Biopharma LLC | Phase 1 | 2013-09-01 | The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of belinostat following IV administration in patients with a recurrent or progressive malignancy. |
| NCT01583777 ↗ | Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer | Completed | Spectrum Pharmaceuticals, Inc | Phase 1 | 2013-09-01 | The purpose of this trial is to study the mass balance, pharmacokinetics (PK), and safety of belinostat following IV administration in patients with a recurrent or progressive malignancy. |
| NCT02137759 ↗ | MRSI to Predict Response to RT/TMZ ± Belinostat in GBM | Active, not recruiting | Johns Hopkins University | Phase 2 | 2014-05-07 | In the first phase of this study (Cohort 1), the investigators will determine the feasibility of adding MRSI to the evaluation of newly-diagnosed GBM patients treated with standard RT/TMZ and determine whether magnetic resonance spectroscopic imaging (MRSI) can predict for better outcomes in these patients. In the second phase of this study (Cohorts 2a and 2b), the investigators will find the maximum tolerated dose of belinostat for treating newly-diagnosed GBM patients with standard RT/TMZ and will determine whether MRSI can aid clinicians in the early determination of response to this new therapy. |
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