Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological MalignanciesPhase 1NCT00472368
A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589
A Phase 1 study testing LBH589 in people with Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
- What is being tested?
- LBH589
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2008
- 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 cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2
- Normal renal and hepatic function
Who cannot join
- Patients with central nervous system (CNS) involvement or brain metastases
- Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
- Patients with congenital long QT syndrome or uncontrolled hypertension
- Patients with a myocardial infarction or unstable angina within 6 months
- Congestive heart failure
- Impairment of gastrointestinal (GI) function
Show all 9Show fewer
- Use of any anti-cancer therapy
- Female patients who are pregnant or breast feeding
- Other protocol inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
Buffalo, New York, 14263
About this study
Official title: An Open-label, Single Center, Study to Determine the Absorption, Distribution, Metabolism, and Excretion (ADME) of LBH589 After a Single Oral Administration of 20 mg (14C) LBH589 in Advanced Cancer Patients
This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.
- Conditions
- Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
- Being tested
- LBH589
- Keywords
- Advanced cancer, lymphoma, chronic hematological malignancies, adult
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589Drug
Also called Panobinostat
| Study group | Role | What they receive |
|---|---|---|
| LBH589 | Experimental | Not described Receives: Drug: LBH589 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589
oral dose of [14C] LBH589
Measured: during the first 8 days on study
Secondary outcomes (1)
Safety Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological MalignanciesStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 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
- NCT00472368
- Sponsor's protocol ID
- CLBH589B2108
- Status last verified
- Apr 2012
- First submitted
- 10 May 2007
- Last updated
- 1 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Center, Study to Determine the Absorption, Distribution, Metabolism, and Excretion (ADME) of LBH589 After a Single Oral Administration of 20 mg (14C) LBH589 in Advanced Cancer Patients
- ClinicalTrials.gov ID
- NCT00472368
- Acronym / sponsor ID
- CLBH589B2108
- Conditions
- Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies
- Keywords
- Advanced cancer, lymphoma, chronic hematological malignancies, adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2008 (actual)
- First posted
- 11 May 2007 (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.
This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LBH589 | 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)
- Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of < 2
- Normal renal and hepatic function
Key exclusion criteria (9 listed)
- Patients with central nervous system (CNS) involvement or brain metastases
- Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
- Patients with congenital long QT syndrome or uncontrolled hypertension
- Patients with a myocardial infarction or unstable angina within 6 months
- Congestive heart failure
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: Panobinostat | Drug | LBH589 |
Primary outcome
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589
Time frame: during the first 8 days on study
oral dose of [14C] LBH589
1 secondary outcome
Safety Efficacy
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 1 May 2012.
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
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 Cancer Patients With Advanced Solid Tumors Including Lymphoma or Chronic Hematological Malignancies, run by Novartis Pharmaceuticals 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 3 inclusion and 9 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 1 May 2012. 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?
Rates and routes of excretion of LBH589 and its metabolites in urine and feces following administration of a single oral dose of [14C] LBH589 (time frame: during the first 8 days on study). 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 1 May 2012.