A Phase 1 interventional study of vorinostat in Lymphoma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-04-21.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Treatment
Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be newly enrolled in Part II.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 10 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria (Parts I \& II):
Drug: vorinostat
Parts I \& II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.
Also known as: MK-0683, Zolinza
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.
Time frame: Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)
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
Time frame: Day 1 to Day 28
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.
Time frame: Days 1 & 28 of Cycle 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.
Time frame: Days 1 & 28 of Cycle 1
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.
Time frame: Days 1 & 28 of Cycle 1
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.
Time frame: Days 1 & 28 of Cycle 1
| Milestone | Part I | Part II |
|---|---|---|
| Started | 6 | 4 |
| Completed | 0 | 0 |
| Not completed | 6 | 4 |
| Withdrew: Physician decision | 2 | 3 |
| Withdrew: Progressive disease | 3 | 1 |
| Withdrew: Protocol violation | 1 | 0 |
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.
| participants | Vorinostat |
|---|---|
| Clinical AEs | 10 |
| Laboratory AEs | 6 |
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.
| µM*hr | Vorinostat |
|---|---|
| Day 1 (n=6) | 4.59 ± 2.34 |
| Day 28 (n=5) | 5.59 ± 1.24 |
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
| participants | Vorinostat |
|---|---|
| Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT) | 1 |
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.
| µM | Vorinostat |
|---|---|
| Day 1 (n=6) | 0.83 ± 0.37 |
| Day 28 (n=5) | 1.17 ± 0.37 |
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.
| hours | Vorinostat |
|---|---|
| Day 1 (n=6) | 2.91 (2.00 to 6.00) |
| Day 28 (n=5) | 3.73 (2.93 to 4.28) |
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.
| hours | Vorinostat |
|---|---|
| Day 1 (n=5) | 1.94 ± 1.30 |
| Day 28 (n=4) | 2.30 ± 1.10 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vorinostat | — | 3/10 (30%) | 10/10 (100%) |
| Event | Vorinostat |
|---|---|
| InfectionInfections and infestations | 2/10 |
| NauseaGastrointestinal disorders | 1/10 |
| VomitingGastrointestinal disorders | 1/10 |
| Cellulitis streptococcalInfections and infestations | 1/10 |
| Event | Vorinostat |
|---|---|
| ThrombocytopeniaBlood and lymphatic system disorders | 8/10 |
| NauseaGastrointestinal disorders | 6/10 |
| AnorexiaMetabolism and nutrition disorders | 6/10 |
| MalaiseGeneral disorders | 5/10 |
| HypoalbuminaemiaMetabolism and nutrition disorders | 5/10 |
| DiarrhoeaGastrointestinal disorders | 4/10 |
| VomitingGastrointestinal disorders | 4/10 |
| FatigueGeneral disorders | 4/10 |
| PyrexiaGeneral disorders | 4/10 |
| HypermagnesaemiaMetabolism and nutrition disorders | 4/10 |
| Age, Continuous(years) | Vorinostat |
|---|---|
| Mean | 55.5 ± 12.0 |
| Sex: Female, Male(Participants) | Vorinostat |
|---|---|
| Female | 2 |
| Male | 8 |
| Region of Enrollment(participants) | Vorinostat |
|---|---|
| Japan | 10 |
No study locations are listed for this record.
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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Merck Sharp & Dohme LLC