Phase 1
Completed N=16
A Study of Oral Suberoylanilide Hydroxamic Acid (Vorinostat) in Patients With Solid Tumors (0683-048)
Source: ClinicalTrials.gov NCT00373490 ↗Enrolled (actual)
16
Serious AEs
25.0%
Results posted
May 2009
Primary outcomePrimary: Number of Participants With a Dose Limiting Toxicity (DLT) — 0; 2 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Dose Limiting Toxicity (DLT) |
0; 2 | — |
| SECONDARY Area Under the Curve (AUC(0-infinity)) at Day 1 (600 mg and 400 mg) |
3.94; 7.75 | — |
| SECONDARY Area Under the Curve (AUC(0-infinity)) at Day 3 (600 mg) |
4.15 | — |
| SECONDARY Area Under the Curve (AUC(0-infinity) at Day 21 (400 mg) |
8.3 | — |
| SECONDARY Maximum Concentration (Cmax) at Day 1 (600 mg and 400 mg) |
1.17; 1.62 | — |
| SECONDARY Maximum Concentration (Cmax) at Day 3 (600 mg) |
1.32 | — |
| SECONDARY Maximum Concentration (Cmax) at Day 21 (400 mg) |
2.04 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00373490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.