At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 15 enrolled
Drug / intervention
Romidepsin +1 moredrug
Likely dose
Romidepsin 8 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I Open-label, 2-period Study to Evaluate the Influence of Multiple Oral Doses of Ketoconazole on the Single Dose Pharmacokinetics of Romidepsin in Subjects With Advanced Cancer
In Brief
A Phase 1 clinical trial evaluating Romidepsin and Ketoconazole for Hematologic Malignancy and Malignant Lymphoma. Completed, enrolled 15 participants across 3 sites in 2 countries.
Detailed Summary
The purpose of this study is to evaluate the effect and safety of multiple doses of ketoconazole on the pharmacokinetics of romidepsin after a single intravenous (IV) infusion.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHematologic Malignancy, Malignant Lymphoma
CountriesUnited Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2011
Enrollment StartApr 2011
Primary CompletionJan 2012
TodayJul 2026
First PostedMar 29, 2011
Enrollment StartApr 1, 2011
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 15.3 years ago
Interventions
Romidepsindrug
Romidepsin 8 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8.
Ketoconazoledrug
Ketoconazole 400 mg oral once daily on Days 4-8