Clinical trial NCT01065467 (phase 1, status: completed)
Conditions: melanoma, malignant melanoma
ICD codes: C43.0, C43.31, D03.9, C43.51, C43.9, D03.0, C43.4, C43.0, C43.31, C43.51, C43.9, C43.4, C43.52, C43.10
Drugs: lbh589
SMILES: [H]\C(=C(\[H])C1=CC=C(CNCCC2=C(C)NC3=CC=CC=C23)C=C1)C(O)=NO
Eligibility criteria:

        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
             administration

          -  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
             earlier

          -  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