Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00128102 | Lung Neoplasms | Number of Participants Who Discontinued Study Treatment Due to an AE Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | Placebo | 49 Participants |
| Vorinostat | 60 Participants | |||
| NCT00128102 | Lung Neoplasms | Number of Participants Who Experienced Adverse Events (AEs) Characterized as Grade 3 or Grade 4 According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | Placebo | 146 Participants |
| Vorinostat | 165 Participants | |||
| NCT00128102 | Lung Neoplasms | Number of Participants Who Experienced an AE Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | Placebo | 311 Participants |
| Vorinostat | 327 Participants | |||
| NCT00128102 | Lung Neoplasms | Overall Survival (OS) Up to ~72 months (through pre-specified final statistical analysis cut-off date of 15-July-2011) | Placebo | 27.1 Weeks |
| Vorinostat | 30.7 Weeks | |||
| NCT00473889 | — | Overall Survival Start of treatment to death | Placebo + Paclitaxel + Carboplatin | 14.0 Months |
| Vorinostat + Paclitaxel + Carboplatin | 11.0 Months | |||
| NCT00773747 | Multiple Myeloma | Progression-Free Survival (PFS) From randomization to event of disease progression or death assessed up to 32 months (final study analysis) | Placebo + Bortezomib | 6.83 Months (±5.67 95% Confidence Interval) |
| Vorinostat + Bortezomib | 7.63 Months (±6.87 95% Confidence Interval) | |||
| NCT01236560 | Astrocytoma | Event-free Survival 1 year after enrollment | Arm I (Vorinostat, Phase II Arm A) | 41.3 percent probability |
| Arm II (Temozolomide, Phase II Arm B) | 59.3 percent probability | |||
| Arm III (Bevacizumab, Phase II Arm C) | 43.8 percent probability | |||
| Feasibility (Vorinostat) | 33.3 percent probability | |||
| NCT01236560 | Astrocytoma | Maximum Tolerated Dose (MTD) of Vorinostat 10 weeks | Feasibility (Vorinostat) | 230 mg/sq m |
| NCT01728805 | Lymphoma, T-Cell, Cutaneous | Progression Free Survival From date of randomization at every visit until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months | KW-0761 | 14.1 percentage of subjects |
| KW-0761 | 4.7 percentage of subjects | |||
| KW-0761 | 38.3 percentage of subjects | |||
| KW-0761 | 55.3 percentage of subjects | |||
| KW-0761 | 28.0 percentage of subjects | |||
| Vorinostat | 7.2 percentage of subjects | |||
| Vorinostat | 7.2 percentage of subjects | |||
| Vorinostat | 7.2 percentage of subjects | |||
| Vorinostat | 15.3 percentage of subjects | |||
| Vorinostat | 28.8 percentage of subjects | |||
| NCT01802333 | Leukemia, Myeloid, Acute | Event-free Survival (EFS) EFS assessed for up to 5 years, 2 year EFS reported | Arm I (Standard Dose Cytarabine, Daunorubicin Hydrochloride) | 0.36 Proportion of participants |
| Arm II (High-dose Cytarabine, Idarubicin) | 0.41 Proportion of participants | |||
| Arm III (Vorinostat, High-dose Cytarabine, Idarubicin) | 0.37 Proportion of participants | |||
| NCT01802333 | Leukemia, Myeloid, Acute | Rate of Allogeneic HCT Up to 5 years | High Risk Patients in First Complete Remission | 65 percentage of patients |