Carcinoma, Non-Small-Cell LungPhase 1NCT00535951
Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma
A Phase 1 study testing LBH589 in people with Carcinoma, Non-Small-Cell Lung and Mesothelioma, run by Novartis Pharmaceuticals at 5 sites in 2 countries.
Trial summary
This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Mesothelioma
- What is being tested?
- LBH589
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Nov 2007to Jan 2009
- 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
- Age ≥ 18 years
- Must have histologically or cytologically confirmed advanced or metastatic incurable solid tumor as documented by CT or MRI that has progressed on or following standard therapies
- Must have failed prior standard systemic therapy
- Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
- Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
- Written informed consent obtained prior to any screening procedures
- Willingness to have multiple blood draws
- Ability to swallow capsules or tablets
Who cannot join
- Uncontrolled brain metastases
- Prior treatment with an HDAC inhibitor
- Presence of clinically detectable third-space fluid collections (e.g., ascites or pleural effusions) that can not be controlled by drainage or other procedures prior to study entry
- Concomitant use of any anti-cancer therapy, including radiation therapy
- Significant cardiac disease
- Concomitant use of drugs with a risk of causing torsades de pointes
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- Previous use of monoamine oxidase inhibitors (e.g. clorgyline, iproniazid, isocarboxazid, moclobemide, sibutramine, phenelzine, tranylcypromine) within 14 days prior to the first dose of dextromethorphan
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Medical College of Georgia
Augusta, Georgia, 30912
RUSH Medical Center
Chicago, Illinois, 60612
Highlands Oncology Group
Fayetteville, Arkansas, 72703
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase IB, Open-Label, Multicenter Study to Investigate the Effect of Oral LBH589 on Dextromethorphan, a CYP2D6 Substrate, and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors
This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients
- Conditions
- Carcinoma, Non-Small-Cell Lung, Mesothelioma
- Being tested
- LBH589
- Keywords
- Non-small cell lung cancer, NSCLC, lung cancer, pleural mesothelioma, malignant, advanced stage, mesothelioma, phase I, LBH589, dextromethorphan, CYP2D6, oral
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Mesothelioma, Lung Neoplasms, Mesothelioma, Malignant
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 |
|---|---|---|
| LBH589 | Experimental | Not described Receives: Drug: LBH589 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic (PK) parameters
Measured: first 10 days
Secondary outcomes (3)
Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs)
Measured: day 10 through end of treatment
Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation
Measured: first 10 days, day 10 through end of treatment plus follow-up
Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation
Measured: day 10 through end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmeceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535951
- Sponsor's protocol ID
- CLBH589B2109
- Status last verified
- Nov 2012
- First submitted
- 26 Sep 2007
- Last updated
- 19 Dec 2020
- Results posted
- No
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 IB, Open-Label, Multicenter Study to Investigate the Effect of Oral LBH589 on Dextromethorphan, a CYP2D6 Substrate, and to Assess the Efficacy and Safety of Oral LBH589 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00535951
- Acronym / sponsor ID
- CLBH589B2109
- Conditions
- Carcinoma, Non-Small-Cell Lung, Mesothelioma
- Keywords
- Non-small cell lung cancer, NSCLC, lung cancer, pleural mesothelioma, malignant, advanced stage, mesothelioma, phase I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jan 2009 (actual)
- First posted
- 27 Sep 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 study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients
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 (8 listed)
- Age ≥ 18 years
- Must have histologically or cytologically confirmed advanced or metastatic incurable solid tumor as documented by CT or MRI that has progressed on or following standard therapies
- Must have failed prior standard systemic therapy
- Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
- Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
Key exclusion criteria (8 listed)
- Uncontrolled brain metastases
- Prior treatment with an HDAC inhibitor
- Presence of clinically detectable third-space fluid collections (e.g., ascites or pleural effusions) that can not be controlled by drainage or other procedures prior to study entry
- Concomitant use of any anti-cancer therapy, including radiation therapy
- Significant cardiac disease
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 | LBH589 |
Primary outcome
Pharmacokinetic (PK) parameters
Time frame: first 10 days
3 secondary outcomes
Response rate assessed by comparing tumor size via radiology scans (CTs or MRIs)
Time frame: day 10 through end of treatment
Safety (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation
Time frame: first 10 days, day 10 through end of treatment plus follow-up
Tolerability (until disease progression, unacceptable toxicity or study completion) assessed by duration of patient participation
Time frame: day 10 through end of treatment
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.
- Results for CLBH589B2109 can be found on the Novartis Clinical Trial Results 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 Pharmeceuticals
5 sites in 2 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 Carcinoma, Non-Small-Cell Lung and Mesothelioma, run by Novartis Pharmaceuticals at 5 sites in 2 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 8 inclusion and 8 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 United States, Canada. 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?
Pharmacokinetic (PK) parameters (time frame: first 10 days). 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 19 Dec 2020.