Clinical trial · Interventional
Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)
Phase I Clinical Study of MK-0683 in Patients With Relapsed or Refractory Cutaneous T-Cell Lymphoma (CTCL)
NCT00771472CI-TRIAL-00017592completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vorinostat
- interventionNames
- Drug: vorinostat
Primary outcomes (2)
- measure
- Parts I & II: Number of Participants Experiencing Clinical or Laboratory Adverse Experiences (AE)
- timeFrame
- Day 1 up until 30 days post study completion or early termination (up to approximately 506 days)
- description
- 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.
- measure
- Part I: Number of Participants Experiencing Dose Limiting Toxicity (DLT)
- timeFrame
- Day 1 to Day 28
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria (Parts I \& II): * Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To At Least One Prior Therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2 * Patients Have Adequate Bone Marrow, Liver Function And Renal Function Exclusion Criteria (Parts I \& II): * Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered From Toxicities Of Prior Therapy * Patients Have Uncontrolled Intercurrent Illness * Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman
References
Publications (1)
- RESULTWada H, Tsuboi R, Kato Y, Sugaya M, Tobinai K, Hamada T, Shimamoto T, Noguchi K, Iwatsuki K. Phase I and pharmacokinetic study of the oral histone deacetylase inhibitor vorinostat in Japanese patients with relapsed or refractory cutaneous T-cell lymphoma. J Dermatol. 2012 Oct;39(10):823-8. doi: 10.1111/j.1346-8138.2012.01554.x. Epub 2012 Apr 16. PMID 22506596