Phase 2
Completed N=27
A Continuation Clinical Trial of Oral Vorinostat (MK-0683) in Advanced Cancers (MK-0683-007)
Source: ClinicalTrials.gov NCT00907738 ↗Enrolled (actual)
27
Serious AEs
25.9%
Results posted
Jul 2011
Primary outcomePrimary: Percent of Participants With a Serious Drug-related Adverse Event (AE) — 7.7; 0; 0; 0 percent of participants
Summary
This study will evaluate the safety and tolerability of continuing vorinostat (MK-0683) dosing in cancer patients previously enrolled in one of five base studies (MK-0683-001, MK-0683-006, MK-0683-008, MK-0683-012, or MK-0683-013) who have shown benefit from receiving this drug.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Participants With a Serious Drug-related Adverse Event (AE) |
7.7; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patient participated in one of the five vorinostat base protocols, has not shown tumor progression on that study, and has tolerated the study drug
- Patient did not withdraw from the base protocol
- Patient agrees to practice effective birth control during the study
Exclusion Criteria
- Patient is receiving other standard and/or investigational anticancer therapy
- Patient has any condition or disease that would interfere with compliance or pose addition risk in administering the study drug
Data sourced from ClinicalTrials.gov (NCT00907738). 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.