A Pilot/Phase I Study of Panobinostat (LBH589) in Patients With Metastatic Melanoma
- Each treatment cycle lasts 28 days. During the cycles, participants will be taking
LBH589 three days a week(Monday, Wednesday and Friday) every other week.
- During all treatment cycles participants will have a physical exam and will be asked
general questions about their health and specific questions about any problems that
they may be having. Participants will be seen at least weekly during the first cycle
and then at least monthly while they remain on the study.
- Blood tests will be taken to check blood cell counts, how well their organs are
functioning and to test for any infections. These blood samples will be obtained prior
to the start of every cycle and at least weekly during the first cycle on this study.
- If the participant is a woman of child-bearing potential, she will be asked to undergo
either a blood test or provide a urine specimen to check for pregnancy before starting
cycle 1 and prior to the start of all subsequent cycles.
- As it is possible for LBH589 to affect the rhythm of the heart, EKGs will be checked
frequently during participation on this study. These EKGs will be performed at the
following time points: Cycle 1, day 1; Cycle 1, day 5; Cycle 1, Day 8; Cycle 1 day 15;
and day 1 of each subsequent cycles.
- CT scans of the chest, abdomen and pelvis and an MRI of the brain will be performed
after every 2 cycles or every 56 days.
- A second sample of the participant's tumor will be removed at the end of the first
cycle on study.
- Participants will be in this research study for at least 2 months and may continue on
the study of they are benefitting from the drug and are not experiencing any serious
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To obtain an early evaluation of efficacy by response rate using RECIST criteria.
F. Stephen Hodi, MD
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|