MelanomaPhase 1NCT01065467
Panobinostat (LBH589) in Patients With Metastatic Melanoma
A Phase 1 study testing LBH589 in people with Melanoma and Malignant Melanoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Malignant Melanoma
- What is being tested?
- LBH589
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to 13 Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Pilot/Phase I Study of Panobinostat (LBH589) in Patients With Metastatic Melanoma
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.
Read the 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.
- Conditions
- Melanoma, Malignant Melanoma
- Being tested
- LBH589
- Keywords
- LBH589, panobinostat
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589Drug
Also called Panobinostat
Taken orally three times per week.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | LBH589 Receives: Drug: LBH589 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To obtain an early evaluation of efficacy by response rate using RECIST criteria.
Measured: 2 years
Secondary outcomes (3)
Tp determine whether LBH589 effectively down regulates MITF in biopsy specimens of treated metastatic melanoma patients
Measured: 2 years
To estimate the disease control rate using RECIST criteria
Measured: 2 years
To estimate time to disease progression.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2013
- Study completion13 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis
- Responsible party
- Principal investigator, F. Stephen Hodi, MD, Dana-Farber Cancer Institute
- Investigators
- F. Stephen Hodi, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065467
- Sponsor's protocol ID
- 09-427
- Other IDs
- CLBH589BUS64T
- Status last verified
- Mar 2017
- First submitted
- 8 Feb 2010
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot/Phase I Study of Panobinostat (LBH589) in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01065467
- Acronym / sponsor ID
- 09-427
- Conditions
- Melanoma, Malignant Melanoma
- Keywords
- LBH589, panobinostat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Novartis
- Study start
- Feb 2010 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- 13 Mar 2017 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: LBH589LBH589 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LBH589Also: PanobinostatTaken orally three times per week. | Drug | Treatment |
Primary outcome
To obtain an early evaluation of efficacy by response rate using RECIST criteria.
Time frame: 2 years
3 secondary outcomes
Tp determine whether LBH589 effectively down regulates MITF in biopsy specimens of treated metastatic melanoma patients
Time frame: 2 years
To estimate the disease control rate using RECIST criteria
Time frame: 2 years
To estimate time to disease progression.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Stephen Hodi, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LBH589 in people with Melanoma and Malignant Melanoma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To obtain an early evaluation of efficacy by response rate using RECIST criteria. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.