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Also known as oral belinostat, belinostat, PXD101
Belinostat, Warfarin · 4 trials · 5 indications
Time from the date of randomization to the time of disease progression or death due to any cause, measured by RECIST criteria (Response Evaluation Criteria In Solid Tumors).
Objective response rate was defined as the percentage of participants with a complete response (CR) or a partial response (PR) according to International Working Group (IWG) criteria. The response was assessed based on clinical and radiological criteria. CR is defined as the disappearance of all evidence of disease. PR is defined as a regression of measurable disease and no new sites. As pre-defined, the primary endpoint analysis for this study was based on the Independent Review Committee (IRC) assessment of response.
Samples will be analyzed for S-warfarin and R-warfarin analytes in all evaluable subjects at the end of the trial
Pharmacokinetic evaluation of belinostat 1,000 mg/m2 and metabolites in the presence of warfarin 5mg
| Arm | Type | Description |
|---|---|---|
| Arm A - BelCaP | EXPERIMENTAL | Group A: belinostat 1000 mg/m² administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat 2000 mg administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel 175 mg/m² administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3. |
| Arm B - CaP | ACTIVE_COMPARATOR | Group B: paclitaxel 175 mg/m² administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle. |
| Belinostat | EXPERIMENTAL | Belinostat 1000 mg/m\^2 administered as a 30 minute IV infusion on Days 1-5 of every 3-week cycle until disease progression or unmanageable treatment-related toxicities. |
| oral belinostat | EXPERIMENTAL | - |
| Warfarin, Belinostat | EXPERIMENTAL | Warfarin 5 mg po will be given on Day -14 and Day 3. Belinostat 1000 mg/m² will be given as a 30 minute IV infusion on Days 1 - 5 |
| Name | Type | Description |
|---|---|---|
| belinostat, carboplatin, paclitaxel | DRUG | - |
| carboplatin, paclitaxel | DRUG | - |
| Belinostat | DRUG | - |
| oral belinostat | DRUG | oral belinostat dosed once or twice daily at continuous and discontinuous dosing schedules. |
| Belinostat, Warfarin | DRUG | 1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO |
Inclusion Criteria: * Patients with CUP where the primary site had not been revealed by complete history, physical examination (including gynecological examination when appropriate), computed tomography (CT) scan of the chest, abdomen and pelvis, bilateral mammography (in women with adenocarcinoma ...
Belinostat is an investigational small molecule studied in oncology for carcinoma of unknown primary, peripheral T-cell lymphoma, and solid tumors. It has been evaluated both as a single agent and in combination regimens, including with carboplatin and paclitaxel and with warfarin, in patients with advanced solid tumors or hematological malignancies.
Belinostat targets histone deacetylases, specifically HDAC1, HDAC2, HDAC3, HDAC5, HDAC6, and HDAC7. It acts as an HDAC inhibitor, a class of small molecule agents that modulate histone acetylation. This target profile is the basis for its investigation across solid tumors and hematological malignancies.
Belinostat is being developed by Assertio Holdings, Inc., which trades under the ticker ASRT. The company is the sponsor associated with the clinical development program for the drug across its oncology indications.
Belinostat is in Phase 2 clinical development and is investigational. It has not been established as approved. The program includes completed Phase 1 and Phase 2 studies, with no active trials currently listed, and a total reported enrollment of 148 patients across the randomized, active-controlled studies.
Belinostat has been studied in completed trials including NCT01317927, a Phase 1 study of belinostat with warfarin in solid tumors or hematological malignancies; NCT00873119, a Phase 2 study of belinostat with carboplatin and paclitaxel in carcinoma of unknown primary; NCT00865969, a Phase 2 study in relapsed or refractory peripheral T-cell lymphoma; and NCT00413075, a Phase 1 study of oral PXD101 in advanced solid tumors or lymphoma.
Yes. Belinostat is also known as oral belinostat and has been referred to as PXD101 in earlier study titles. These names refer to the same HDAC inhibitor small molecule, so searches using oral belinostat or PXD101 point to the same investigational oncology asset.