Clinical trial · Interventional
A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)
MK0683 Phase1 Clinical Study - Solid Tumor -
NCT00373490CI-TRIAL-00018965completedPhase 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)
This is a clinical study to evaluate the safety and pharmacokinetics of an overseas determined maximum tolerated dose (MTD) of MK-0683 (vorinostat) in a Japanese patient population with solid tumors.
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 |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vorinostat | Drug | Vorinostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vorinostat 600 mg
- description
- 600 mg daily (300 mg twice daily \[b.i.d.\]) for 3 consecutive days followed by 4 days of rest.
- interventionNames
- Drug: Vorinostat
- type
- EXPERIMENTAL
- label
- Vorinostat 400 mg
- description
- 400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days.
- interventionNames
- Drug: Vorinostat
Primary outcomes (1)
- measure
- Number of Participants With a Dose Limiting Toxicity (DLT)
- timeFrame
- 21 Days (first cycle)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically or cytologically diagnosed solid tumor in whom no standard therapy is available or the malignancy is refractory to standard therapy Exclusion Criteria: * Patients with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks * Any uncontrolled concomitant illness * Pregnant or breast-feeding * Serious drug or food allergy
References
Publications (1)
- RESULTDoi T, Hamaguchi T, Shirao K, Chin K, Hatake K, Noguchi K, Otsuki T, Mehta A, Ohtsu A. Evaluation of safety, pharmacokinetics, and efficacy of vorinostat, a histone deacetylase inhibitor, in the treatment of gastrointestinal (GI) cancer in a phase I clinical trial. Int J Clin Oncol. 2013 Feb;18(1):87-95. doi: 10.1007/s10147-011-0348-6. Epub 2012 Jan 11. PMID 22234637