Panobinostat (LBH589) in Patients With Metastatic Melanoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01065467|
Recruitment Status : Completed
First Posted : February 9, 2010
Last Update Posted : March 28, 2017
|Condition or disease||Intervention/treatment||Phase|
|Melanoma Malignant Melanoma||Drug: LBH589||Phase 1|
- 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 side effects.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot/Phase I Study of Panobinostat (LBH589) in Patients With Metastatic Melanoma|
|Actual Study Start Date :||February 2010|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 13, 2017|
Taken orally three times per week.
Other Name: Panobinostat
- To obtain an early evaluation of efficacy by response rate using RECIST criteria. [ Time Frame: 2 years ]
- Tp determine whether LBH589 effectively down regulates MITF in biopsy specimens of treated metastatic melanoma patients [ Time Frame: 2 years ]
- To estimate the disease control rate using RECIST criteria [ Time Frame: 2 years ]
- To estimate time to disease progression. [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065467
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||F. Stephen Hodi, MD||Dana-Farber Cancer Institute|