Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as oral belinostat, belinostat, belinostat, carboplatin, paclitaxel, Belinostat
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 ...