Phase 1
Completed N=18
A Study of Vorinostat in Patients With Solid Tumors (MK-0683-029)
Source: ClinicalTrials.gov NCT00127127 ↗Enrolled (actual)
18
Serious AEs
10.5%
Results posted
May 2022
Primary outcomePrimary: Number of Participants Who Experienced One or More Adverse Events — 4; 6; 3; 6 Participants
Summary
The primary purpose of this trial is to determine the maximum tolerated dose (MTD), or the maximum acceptable dose (MAD) and evaluate the dose limiting toxicity (DLT) of oral suberoylanilide hydroxamic acid in participants with solid tumors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experienced One or More Adverse Events |
4; 6; 3; 6 | — |
| PRIMARY Number of Participants Who Discontinued Study Treatment Due to an Adverse Event |
0; 1; 0; 1 | — |
| PRIMARY Number of Participants With a Dose-Limiting Toxicity (DLT) During Cycle 1 |
0; 3; 0; 2 | — |
| SECONDARY Area Under the Plasma Concentration Time Curve From Hour 0 to Infinity (AUC0-inf) of Vorinostat After a Single Oral Dose in a Fasted State |
1.20; 2.31; 3.96; 3.47 | — |
| SECONDARY AUC0-Inf of Vorinostat After a Single Oral Dose in a Fed State |
0.98; 2.22; 4.30; 5.93 | — |
| SECONDARY AUC0-inf of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration |
1.33; 2.76; 5.41; 6.33 | — |
| SECONDARY Maximum Concentration (Cmax) of Vorinostat After a Single Oral Dose in a Fasted State |
0.49; 0.77; 1.19; 1.06 | — |
| SECONDARY Cmax of Vorinostat After a Single Oral Dose in a Fed State |
0.21; 0.59; 0.93; 1.35 | — |
| SECONDARY Cmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration |
0.29; 0.84; 0.86; 1.09 | — |
| SECONDARY Time to Maximum Concentration (Tmax) of Vorinostat After a Single Oral Dose in a Fasted State |
0.84; 1.59; 2.49; 1.91 | — |
| SECONDARY Tmax of Vorinostat After a Single Oral Dose in a Fed State |
5.66; 3.00; 3.53; 3.17 | — |
| SECONDARY Tmax of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration |
4.66; 3.30; 4.34; 4.61 | — |
| SECONDARY Apparent Terminal Half-Life (t½) of Vorinostat After a Single Oral Dose in a Fasted State |
1.08; 1.83; 1.90; 1.93 | — |
| SECONDARY t½ of Vorinostat After a Single Oral Dose in a Fed State |
1.62; 1.36; 2.01; 1.60 | — |
| SECONDARY t½ of Vorinostat After 14 Days of Once-Daily or Twice-Daily Administration |
1.95; 1.42; 1.98; 1.30 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with histologically or cytologically diagnosed solid tumor; no standard therapy available or participant has failed to respond to standard therapy
Exclusion Criteria
- Participants with history of immunotherapy, radiotherapy, surgery, or chemotherapy during the previous 4 weeks; previous treatment is 5 or more chemotherapeutic regimens.
- Any uncontrolled concomitant illness
- Are pregnant or breast-feeding
- Serious drug or food allergy
Data sourced from ClinicalTrials.gov (NCT00127127). 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.