Page last updated: 2024-11-04
vorinostat and Bilirubinemia
vorinostat has been researched along with Bilirubinemia in 1 studies
Vorinostat: A hydroxamic acid and anilide derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used in the treatment of CUTANEOUS T-CELL LYMPHOMA and SEZARY SYNDROME.
vorinostat : A dicarboxylic acid diamide comprising suberic (octanedioic) acid coupled to aniline and hydroxylamine. A histone deacetylase inhibitor, it is marketed under the name Zolinza for the treatment of cutaneous T cell lymphoma (CTCL).
Research Excerpts
| Excerpt | Relevance | Reference |
|---|
| "A phase I study was conducted to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of the oral histone deacetylase (HDAC) inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL)." | 9.16 | Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. ( Hamada, T; Iwatsuki, K; Kato, Y; Noguchi, K; Shimamoto, T; Sugaya, M; Tobinai, K; Tsuboi, R; Wada, H, 2012) |
| "A phase I study was conducted to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of the oral histone deacetylase (HDAC) inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL)." | 5.16 | Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. ( Hamada, T; Iwatsuki, K; Kato, Y; Noguchi, K; Shimamoto, T; Sugaya, M; Tobinai, K; Tsuboi, R; Wada, H, 2012) |
Research
Studies (1)
| Timeframe | Studies, this research(%) | All Research% |
|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 1 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
Authors
| Authors | Studies |
|---|
| Wada, H | 1 |
| Tsuboi, R | 1 |
| Kato, Y | 1 |
| Sugaya, M | 1 |
| Tobinai, K | 1 |
| Hamada, T | 1 |
| Shimamoto, T | 1 |
| Noguchi, K | 1 |
| Iwatsuki, K | 1 |
Clinical Trials (1)
Trial Overview
| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)[NCT00771472] | Phase 1 | 10 participants (Actual) | Interventional | 2008-08-31 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)
"A DLT was defined as any of the following (per Common Terminology Criteria for Adverse Events [CTCAE] version 3.0):~Grade 3 (severe)-4 (life-threatening) neutropenia with fever ≥ 38.5ºC~Grade 3-4 neutropenia with an infection requiring antibiotic or antifungal treatment~Grade 4 neutropenia lasting at least 5 days~Grade 4 thrombocytopenia~Other Grade 4 hematologic toxicity, including a decrease in hemoglobin, only at the discretion of the principal investigator~Grade 3 or 4 non-hematologic event, except which are manageable by supportive care or non-prohibited therapies" (NCT00771472)
Timeframe: Day 1 to Day 28
| Intervention | participants (Number) |
|---|
| Vorinostat | 1 |
Part I: Maximum Drug Concentration (Cmax)
"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1
| Intervention | µM (Geometric Mean) |
|---|
| Day 1 (n=6) | Day 28 (n=5) |
|---|
| Vorinostat | 0.83 | 1.17 |
Part I: The Amount of Time it Takes for the Drug Concentration to Decrease by Half (T1/2)
"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1
| Intervention | hours (Geometric Mean) |
|---|
| Day 1 (n=5) | Day 28 (n=4) |
|---|
| Vorinostat | 1.94 | 2.30 |
Part I: Time at Which Cmax Occurs (Tmax)
"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1
| Intervention | hours (Median) |
|---|
| Day 1 (n=6) | Day 28 (n=5) |
|---|
| Vorinostat | 2.91 | 3.73 |
Part I: Total Drug Exposure (Area Under the Concentration Curve, AUC[0-24 Hours])
"Blood samples taken as follows:~Day 1 & Day 28 of Cycle 1: pre dose, and 0.25, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, 8.0, 10, 12 and 24 hours after dosing of vorinostat." (NCT00771472)
Timeframe: Days 1 & 28 of Cycle 1
| Intervention | µM*hr (Geometric Mean) |
|---|
| Day 1 (n=6) | Day 28 (n=5) |
|---|
| Vorinostat | 4.59 | 5.59 |
Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)
A laboratory AE is defined as any unfavorable & unintended change in the chemistry of the body temporally associated with the use of study product, whether or not considered related to the use of the product. A clinical AE is defined similarly but also includes changes in structure or function of the body. (NCT00771472)
Timeframe: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)
| Intervention | participants (Number) |
|---|
| Clinical AEs | Laboratory AEs |
|---|
| Vorinostat | 10 | 6 |
Trials
1 trial available for vorinostat and Bilirubinemia