A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of CC-486 (ORAL-AZA, ONUREG) in Subjects with Moderate or Severe Hepatic Impairment Compared with Normal Hepatic Function in Adult Subjects with Myeloid Malignancies

UVA Tracking #
301314
Principal Investigator
Michael K Keng
Contact
Contact Phone
Official Trial Title
A Phase 1, Multicenter, Open-Label Study to Evaluate the Pharmacokinetics of CC-486 (ORAL-AZA, ONUREG) in Subjects with Moderate or Severe Hepatic Impairment Compared with Normal Hepatic Function in Adult Subjects with Myeloid Malignancies
Study Description

The University of Virginia is participating in a clinical research study for adults ages 18 and over, who have Myeloid Malignancies with moderate or severe hepatic impairment compared with normal hepatic function. The purpose of this study is to see if people with myeloid diseases and hepatic impaired function can receive the same dose of Onureg® as people with myeloid diseases and normal hepatic function.

The average study participation is expected to be 8 months, including a screening phase of up to 21 days, PK Phase of 4 days, and Treatment Phase as long as you receive clinical benefit plus 28 days of follow-up. Based on how you respond to the drug, your participation may be shorter or longer. If you respond to the treatment you will continue on therapy as long as you benefit from it.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/study/PENDING NCT NUMBER

uvacancertrials@hscmail.mcc.virginia.edu

The (department, division name) seeks (insert as applies: adults/men/women/adolescents/children) ages (insert) with (insert condition) for a research study. The purpose of the study is (insert purpose of study - eg.to test the effectiveness of an investigational medicine; or to find out how stress effects blood pressure.)

(Optional)You may be eligible for this study if: (insert brief eligibility criteria 3 or 4 top criteria and in lay language. Do not copy eligibility criteria from the protocol)

Study involves (insert procedures-examples: taking an experimental medicine/placebo, blood draws, x rays, overnight stays,) (Insert x number of visits every x (weeks, months,) each visit lasting x amount of time or give range).

Insert one of the following:
Study-related (insert exams, tests and experimental medication) provided at no cost.
or
Participant’s insurance company will be billed for medication, test,s and procedures

Compensation

No Compensation