Prostate CancerPhase 1NCT00670553
A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer
A Phase 1 study testing panobinostat in people with Prostate Cancer and Head & Neck Cancer, run by Novartis Pharmaceuticals at 1 site in Belgium.
Trial summary
The purpose of this study is to assess the feasibility of combined administration of different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated in future studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Head & Neck Cancer, Esophageal Cancer
- What is being tested?
- panobinostat
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2008to Jan 2010
- 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
- Patients with age ≥18 years
- Confirmed diagnosis of prostate cancer, SCC esophageal cancer or head \& neck cancer
- No evidence of distant spread of the disease
Who cannot join
- Patients who have severe and/or uncontrolled medical conditions
- Female patients who are pregnant or breast feeding
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the feasibility of combined administration of different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated in future studies.
- Conditions
- Prostate Cancer, Head & Neck Cancer, Esophageal Cancer
- Being tested
- panobinostat
- Keywords
- Prostate,, Head & Neck,, Esophageal
- Medical subject headings
- Prostatic Neoplasms, Head and Neck Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
panobinostatDrug
Also called LBH589
| Study group | Role | What they receive |
|---|---|---|
| LBH589 | Experimental | Not described Receives: Drug: panobinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
Measured: 1 to 28 days
Secondary outcomes (1)
Safety profile of oral LBH589 when given in combination with standard Radiotherapy
Measured: min 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startSep 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- 7 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
- NCT00670553
- Sponsor's protocol ID
- CLBH589CBE01
- Status last verified
- May 2017
- First submitted
- 30 Apr 2008
- Last updated
- 17 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of LBH589 (Panobinostat) in Combination With External Beam Radiotherapy for the Treatment of Prostate Cancer, Esophageal Cancer and Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT00670553
- Acronym / sponsor ID
- CLBH589CBE01
- Conditions
- Prostate Cancer, Head & Neck Cancer, Esophageal Cancer
- Keywords
- Prostate,, Head & Neck,, Esophageal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 2 May 2008 (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 study is to assess the feasibility of combined administration of different LBH589 dosages with radiotherapy in order to establish the dosage to be evaluated in future studies.
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: panobinostat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with age ≥18 years
- Confirmed diagnosis of prostate cancer, SCC esophageal cancer or head \& neck cancer
- No evidence of distant spread of the disease
Key exclusion criteria (3 listed)
- Patients who have severe and/or uncontrolled medical conditions
- Female patients who are pregnant or breast feeding
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| panobinostatAlso: LBH589 | Drug | LBH589 |
Primary outcome
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD)
Time frame: 1 to 28 days
1 secondary outcome
Safety profile of oral LBH589 when given in combination with standard Radiotherapy
Time frame: min 1 month
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 17 May 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.
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 panobinostat in people with Prostate Cancer and Head & Neck Cancer, run by Novartis Pharmaceuticals at 1 site in Belgium.
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 3 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 17 May 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 Belgium. 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?
Establish Dose Limiting Toxicity (DLT) and Maximum Tolerated Dose (MTD) (time frame: 1 to 28 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 17 May 2017.