Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01065467
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01065467
Study Brief:
Protocol Section:
NCT01065467