MedTrace Logo

Influence of Ketoconazole on the Pharmacokinetics of Romidepsin in Patients With Advanced Cancer

NCT01324310 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-11-25

Study results available
· View outcomes & findings →

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.

Conditions

  • Hematologic Malignancy
  • Malignant Lymphoma

Interventions

DRUG

Romidepsin

Romidepsin 8 mg/m\^2 intravenous infused over 4 hours on Day 1 and Day 8.

DRUG

Ketoconazole

Ketoconazole 400 mg oral once daily on Days 4-8

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Ken Takeshita, MD · Celgene Corporation

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-01
Primary Completion
2012-01-01
Completion
2012-01-01

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01324310 on ClinicalTrials.gov