Advanced Solid TumorsPhase 1NCT01007968
Pharmacokinetics and Safety of Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function
A Phase 1 study testing LBH589 in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 6 sites in 5 countries.
Trial summary
Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- LBH589
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesin 5 countries
- Study dates
- Mar 2010to Nov 2012
- 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
- Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
- Patient has normal or abnormal hepatic organ function
- Patient has provided written informed consent prior to any screening procedures
Who cannot join
- Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
- Patient received prior treatment with DAC inhibitors including panobinostat
- Patient requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug
- Patient has encephalopathy
- Patient has ascites requiring intervention
- Female patient who is pregnant or breast feeding or with childbearing potential and not willing to use a double method of contraception up to 3 months after the end of study treatment. Male patient who is not willing to use a barrier method of contraception up to 3 months after the end of study treatment.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
6 sites in 5 countries.
6 sites in 5 countries
Sweden2 sites
Novartis Investigative Site
Lund, SE-221 85
Novartis Investigative Site
Stockholm, SE-171 76
United States1 site
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, 84103
About this study
Official title: A Phase I, Open-label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function
Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies.
To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated.
Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of hepatic function status on panobinostat PK.
- Conditions
- Advanced Solid Tumors
- Being tested
- LBH589
- Keywords
- solid tumors, hepatic function, advanced, panobinostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589Drug
| Study group | Role | What they receive |
|---|---|---|
| HDACi | Experimental | Not described Receives: Drug: LBH589 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat.
Measured: first 7 days
Secondary outcomes (3)
To assess the effect of various degrees of impairment in hepatic function on the safety of panobinostat
Measured: entire duration of study
To evaluate whether there is a relationship between panobinostat PK and safety parameters in patients with various degrees of hepatic organ function
Measured: first 7 days
To explore anti-tumor activity associated with panobinostat.
Measured: best overall response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01007968
- Sponsor's protocol ID
- CLBH589X2101
- Other IDs
- 2009-012262-31, 2009
- Status last verified
- Aug 2016
- First submitted
- 28 Oct 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Slingerland M, Hess D, Clive S, Sharma S, Sandstrom P, Loman N, Porro MG, Mu S, Waldron E, Valera SZ, Gelderblom H. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees of hepatic function. Cancer Chemother Pharmacol. 2014 Nov;74(5):1089-98. doi: 10.1007/s00280-014-2594-6. Epub 2014 Sep 25.
PubMed 25253045
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Various Degrees of Hepatic Function
- ClinicalTrials.gov ID
- NCT01007968
- Acronym / sponsor ID
- CLBH589X2101
- Conditions
- Advanced Solid Tumors
- Keywords
- solid tumors, hepatic function, advanced, panobinostat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 5 Nov 2009 (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.
Panobinostat (LBH589) is a deacetylase inhibitor (DACi) which belongs to a structurally novel cinnamic hydroxamic acid class of compounds. It is one of the most potent class I/II pan-DAC inhibitor (pan-DACi) that has shown anti-tumor activity in pre-clinical models and patients with solid tumors and hematological malignancies.
To date, the pharmacokinetics (PK) of panobinostat has been characterized in patients with solid tumors and hematological malignancies participating in several phase I/II clinical studies. Panobinostat PK does not appear to be different in patients with solid tumors and hematological malignancies. However, the effect of organ dysfunction on PK of panobinostat is yet to be elucidated.
Kidney and liver are involved in the elimination and metabolism of panobinostat. The current study is designed to evaluate the impact of hepatic function status on panobinostat PK.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDACi | Experimental | Drug: LBH589 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient has documented diagnosis of advanced solid tumor for which no standard systemic therapy exists
- Patient has normal or abnormal hepatic organ function
- Patient has provided written informed consent prior to any screening procedures
Key exclusion criteria (7 listed)
- Patient needing valproic acid for any medical condition during the study or within 5 days prior to the first panobinostat dose
- Patient received prior treatment with DAC inhibitors including panobinostat
- Patient requires treatment with warfarin that cannot be switched to another anticoagulant treatment prior to starting study drug
- Patient has encephalopathy
- Patient has ascites requiring intervention
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 |
|---|---|---|
| LBH589 | Drug | HDACi |
Primary outcome
To assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat.
Time frame: first 7 days
3 secondary outcomes
To assess the effect of various degrees of impairment in hepatic function on the safety of panobinostat
Time frame: entire duration of study
To evaluate whether there is a relationship between panobinostat PK and safety parameters in patients with various degrees of hepatic organ function
Time frame: first 7 days
To explore anti-tumor activity associated with panobinostat.
Time frame: best overall response
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 19 Dec 2020.
- Derived from this study: PubMed 25253045Slingerland M, Hess D, Clive S, Sharma S, Sandstrom P, Loman N, Porro MG, Mu S, Waldron E, Valera SZ, Gelderblom H. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and various degrees of hepatic function. Cancer Chemother Pharmacol. 2014 Nov;74(5):1089-98. doi: 10.1007/s00280-014-2594-6. Epub 2014 Sep 25.
- Results for CLBH589X2101 on the Novartis clinical trial websiteLink provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
6 sites in 5 countries: 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 Advanced Solid Tumors, run by Novartis Pharmaceuticals at 6 sites in 5 countries.
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 3 inclusion and 7 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden, United States, Netherlands, Switzerland, United Kingdom. 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 assess the effect of various degrees of impairment in hepatic function as measured by the National Cancer Institute-Cancer Therapy Evaluation Program (NCI-CTEP) criteria, on the pharmacokinetics of panobinostat. (time frame: first 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01007968, which also lists 1 linked publication.
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 19 Dec 2020.