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Panobinostat (LBH589) in Patients With Metastatic Melanoma

Primary Purpose

Melanoma, Malignant Melanoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LBH589

About this trial

This is an interventional treatment trial for Melanoma focused on measuring LBH589, panobinostat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

LBH589

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

To estimate the disease control rate using RECIST criteria

To estimate time to disease progression.

Full Information

NCT ID

NCT01065467

First Posted

February 8, 2010

Last Updated

March 27, 2017

Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Novartis

1. Study Identification

Unique Protocol Identification Number

NCT01065467

Brief Title

Panobinostat (LBH589) in Patients With Metastatic Melanoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

February 2010 (Actual)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 13, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

Collaborators

Brigham and Women's Hospital, Novartis

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma, Malignant Melanoma

Keywords

LBH589, panobinostat

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

LBH589

Intervention Type

Drug

Intervention Name(s)

LBH589

Other Intervention Name(s)

Panobinostat

Intervention Description

Taken orally three times per week.

Primary Outcome Measure Information:

Title

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

Time Frame

2 years

Secondary Outcome Measure Information:

Title

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

Time Frame

2 years

Title

To estimate the disease control rate using RECIST criteria

Time Frame

2 years

Title

To estimate time to disease progression.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

F. Stephen Hodi, MD

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

12. IPD Sharing Statement

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Panobinostat (LBH589) in Patients With Metastatic Melanoma

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