Panobinostat (LBH589) in Patients With Metastatic Melanoma

NCT01065467 | Completed Phase 1 DMC

• 2 other identifiers: 09-427CLBH589BUS64T
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the safety of LBH589 as well as to find out what side effects it may cause and how effective it is against melanoma. LBH589 is a drug which may slow down the growth of cancer cells or kill cancer cells by blocking certain enzymes, which are proteins normally produced by cells. These enzymes are known to play an important role in the development and reproduction of cancer cells. It is believed that LBH589 works by helping to promote the activity of enzymes which turn on the mechanisms in our cells that suppress cells from becoming cancerous.

Conditions

Melanoma; Malignant Melanoma

Keywords

LBH589; panobinostat

Outcome Measures

Primary Outcomes (1)

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

  2 years

Secondary Outcomes (3)

• Tp determine whether LBH589 effectively down regulates MITF in biopsy specimens of treated metastatic melanoma patients

  2 years

• To estimate the disease control rate using RECIST criteria

  2 years

• To estimate time to disease progression.

  3 years

Study Arms (1)

Treatment

EXPERIMENTAL

LBH589

Drug: LBH589

Interventions

LBH589 DRUG

Taken orally three times per week.

Also known as: Panobinostat

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed metastatic melanoma
• Measurable disease
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Novartis: collaborator

Study Sites (1)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Melanoma

Interventions

Panobinostat

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• F. Stephen Hodi, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Melanoma Disease Center Director

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 13, 2017
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

US (1)