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A Pilot/Phase I Study of Panobinostat (LBH589) in Patients With Metastatic Melanoma

Phase 1
18 Years
Open (Enrolling)
Melanoma, Malignant Melanoma

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Trial Information

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
side effects.

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic melanoma

- Measurable disease

- 18 years of age or older

- ECOG performance status of 0, 1 or 2

- Normal organ and marrow function as outlined in the protocol

- Women of childbearing potential must have a negative serum pregnancy test within 7
days of the first administration of study treatment and must be willing to use two
methods of contraception during the study and for 3 months after last study drug

- Clinically euthyroid

- Biopsiable disease: Disease must be in the opinion of the treating investigator
biopsiable such that there are minimal risks involved

Exclusion Criteria:

- Chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who
have not recovered from adverse events due to agents administered more than 4 weeks

- May not be receiving any other study agents, anti-cancer therapy or radiation therapy

- Known brain metastases or any history of brain metastases

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to LBH589

- Concomitant use of drugs with a risk of causing torsades de pointes

- Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer

- Patients who will need valproic acid for any medical condition during the study or
within 5 days prior to first LBH589 treatment

- Impaired cardiac function

- Uncontrolled hypertension

- Patients with unresolved diarrhea grade 2 or greater

- Impairment of the gastrointestinal (GI) function or GI disease that may significantly
alter the absorption of oral LBH589

- Pregnant or breastfeeding women

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances: disease-free for at least 5 years and are deemed by the
investigator to be at low risk for recurrence of that malignancy; individuals with
the following cancers are eligible if diagnosed and treated within the past 5 years:
cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.

- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C

- Patients with any significant history of non-compliance to medical regimens or with
inability to grant a reliable informed consent

- Uncontrolled and/or severe intercurrent illness including, but not limited to ongoing
or active infection or psychiatric illness/social situations that would limit
compliance with study requirements

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To obtain an early evaluation of efficacy by response rate using RECIST criteria.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

F. Stephen Hodi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

February 2010

Completion Date:

December 2013

Related Keywords:

  • Melanoma
  • Malignant Melanoma
  • LBH589
  • panobinostat
  • Melanoma



Dana-Farber Cancer Institute Boston, Massachusetts  02115