Advanced Solid TumorsPhase 1NCT00997399
Study to Evaluate Panobinostat (DACi) Pharmacokinetics and Safety in Solid Tumors and Varying Renal Function
A Phase 1 study testing panobinostat (LBH589) in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 5 sites in 4 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?
- panobinostat (LBH589)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Mar 2010to Jun 2014
- 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 renal 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 requiring dialysis
- Patient requiring diuretics unless patient is taking potassium sparring diuretics
- Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
- 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
5 sites in 4 countries.
5 sites in 4 countries
Netherlands2 sites
Novartis Investigative Site
Leiden, 2300 RC
Novartis Investigative Site
Utrecht, 3584CX
United States1 site
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, 84103
About this study
Official title: A Phase I, Open-label, Multi-center Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Varying Degrees of Renal 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 renal function status on panobinostat PK.
- Conditions
- Advanced Solid Tumors
- Being tested
- panobinostat (LBH589)
- Keywords
- Ph I, panobinostat (DACi), PK & safety, solid tumors, varying renal function, advanced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panobinostat (LBH589)Drug
| Study group | Role | What they receive |
|---|---|---|
| LBH589 | Experimental | Not described Receives: Drug: panobinostat (LBH589) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of varying degrees of renal function as defined by creatinine clearance), on the pharmacokinetics of panobinostat.
Measured: First 7 days
Secondary outcomes (3)
To assess the effect of varying degrees of renal function on the safety of panobinostat
Measured: Entire duration of study
To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function.
Measured: 7 days
To explore anti-tumor activity associated with panobinostat.
Measured: 6 months (6 cycles)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2009 (estimated)
- Study startMar 2010
- Primary completionJun 2014
- Study completionJun 2014
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
- 37 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
- NCT00997399
- Sponsor's protocol ID
- CLBH589X2105
- Other IDs
- 2009-012263-34, 2009
- Status last verified
- Jul 2019
- First submitted
- 15 Oct 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
Sharma S, Witteveen PO, Lolkema MP, Hess D, Gelderblom H, Hussain SA, Porro MG, Waldron E, Valera SZ, Mu S. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal function. Cancer Chemother Pharmacol. 2015 Jan;75(1):87-95. doi: 10.1007/s00280-014-2612-8. Epub 2014 Nov 7.
PubMed 25377157
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, Multi-center Study to Evaluate the Pharmacokinetics and Safety of Oral Panobinostat in Patients With Advanced Solid Tumors and Varying Degrees of Renal Function
- ClinicalTrials.gov ID
- NCT00997399
- Acronym / sponsor ID
- CLBH589X2105
- Conditions
- Advanced Solid Tumors
- Keywords
- Ph I, panobinostat (DACi), PK & safety, solid tumors, varying renal function, advanced
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Oct 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 renal 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 |
|---|---|---|
| LBH589 | Experimental | Drug: panobinostat (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 renal 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 requiring dialysis
- Patient requiring diuretics unless patient is taking potassium sparring diuretics
- Patient has acute renal failure, history of transplant, ESRD (however acceptable severe renal impaired group)
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 |
|---|---|---|
| panobinostat (LBH589) | Drug | LBH589 |
Primary outcome
To assess the effect of varying degrees of renal function as defined by creatinine clearance), on the pharmacokinetics of panobinostat.
Time frame: First 7 days
3 secondary outcomes
To assess the effect of varying degrees of renal function on the safety of panobinostat
Time frame: Entire duration of study
To evaluate whether there is a relationship between PK and safety parameters in patients with varying degrees of renal function.
Time frame: 7 days
To explore anti-tumor activity associated with panobinostat.
Time frame: 6 months (6 cycles)
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 25377157Sharma S, Witteveen PO, Lolkema MP, Hess D, Gelderblom H, Hussain SA, Porro MG, Waldron E, Valera SZ, Mu S. A phase I, open-label, multicenter study to evaluate the pharmacokinetics and safety of oral panobinostat in patients with advanced solid tumors and varying degrees of renal function. Cancer Chemother Pharmacol. 2015 Jan;75(1):87-95. doi: 10.1007/s00280-014-2612-8. Epub 2014 Nov 7.
- Results for CLBH589X2105 on the Novartis Clinical Trial WebsiteLink provided by the sponsor.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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Active, not recruitingPhase 2
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RecruitingPhase 1/2
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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
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing panobinostat (LBH589) in people with Advanced Solid Tumors, run by Novartis Pharmaceuticals at 5 sites in 4 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 5 sites in Netherlands, United States, 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 varying degrees of renal function as defined by creatinine clearance), 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 NCT00997399, 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.