Prostate CancerPhase 1NCT00663832
A Dose Finding Study With I.V. Panobinostat (LBH589), Docetaxel, and Prednisone in Patients With Hormone Refractory Prostate Cancer
A Phase 1 study testing LBH589 (i.v. panobinostat) in people with Prostate Cancer, run by Novartis Pharmaceuticals at 9 sites in 2 countries.
Trial summary
This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- LBH589 (i.v. panobinostat)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Feb 2008to Dec 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HRPC patients
- Evidence of disease progression
- Self care, able to perform light work activities
- Willing to use contraception throughout the study and for 12 weeks after study completion
Who cannot join
- History of other cancers not curatively treated with no evidence of disease for more than 5 years.
- Prior radiotherapy within 3 weeks of starting study treatment
- Prior radiopharmaceuticals (strontium, samarium).
- Impaired cardiac function
- Heart disease
- Liver or renal disease with impaired functions.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States7 sites
Novartis Investigative Site
Detroit, Michigan, 48201
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Las Vegas, Nevada, 89135
Novartis Investigative Site
New York, New York, 10021
Novartis Investigative Site
Portland, Oregon, 97239
Novartis Investigative Site
Rockville, Maryland, 20850
Novartis Investigative Site
St Louis, Missouri, 63110
Canada2 sites
Novartis Investigative Site
Hamilton, Ontario, L8V 5C2
Novartis Investigative Site
Vancouver, British Columbia, V5Z 1L8
About this study
Official title: An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer
This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- LBH589 (i.v. panobinostat)
- Keywords
- Male, Prostate, Cancer, HRPC, DACi
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589 (i.v. panobinostat)Drug
Also called Panobinostat
i.v. LBH589 dose levels: 10, 15, or 20 mg/m2
i.v. docetaxel 75 or 60 mg/m2
oral prednisone 5mg bid.
LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| LBH589 | Experimental | Not described Receives: Drug: LBH589 (i.v. panobinostat) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
Measured: determine if MTD occurs after every 3 - 6 pts
Secondary outcomes (3)
To compare the PK profile of i.v. LBH589 with and without docetaxel
Measured: PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
Measured: PK assessment will occur during the first 2 weeks of each pt treatment
To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone
Measured: PK assessment will occur during the first 2 weeks of each pt treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2011
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
- 44 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
- NCT00663832
- Sponsor's protocol ID
- CLBH589C2205
- Other IDs
- 2007-003315-30
- Status last verified
- May 2012
- First submitted
- 18 Apr 2008
- 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
- An Open Label, Single Arm, Phase Ib Dose Finding Study of i.v. Panobinostat (LBH589) With Docetaxel and Prednisone in Patients With Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00663832
- Acronym / sponsor ID
- CLBH589C2205
- Conditions
- Prostate Cancer
- Keywords
- Male, Prostate, Cancer, HRPC, DACi
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Dec 2011 (actual)
- First posted
- 22 Apr 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.
This Phase Ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (LBH589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.
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 (i.v. panobinostat) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- HRPC patients
- Evidence of disease progression
- Self care, able to perform light work activities
- Willing to use contraception throughout the study and for 12 weeks after study completion
Key exclusion criteria (7 listed)
- History of other cancers not curatively treated with no evidence of disease for more than 5 years.
- Prior radiotherapy within 3 weeks of starting study treatment
- Prior radiopharmaceuticals (strontium, samarium).
- Impaired cardiac function
- Heart 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 (i.v. panobinostat)Also: Panobinostati.v. LBH589 dose levels: 10, 15, or 20 mg/m2 i.v. docetaxel 75 or 60 mg/m2 oral prednisone 5mg bid. LBH589 i.v. administered on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o 5mg bid every day of a 21-day cycle | Drug | LBH589 |
Primary outcome
To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
Time frame: determine if MTD occurs after every 3 - 6 pts
3 secondary outcomes
To compare the PK profile of i.v. LBH589 with and without docetaxel
Time frame: PK assessment will occur during the first 2 weeks of each pt treatment. Minor safety throughout the study treatment phase
To determine safety and tolerability of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC
Time frame: PK assessment will occur during the first 2 weeks of each pt treatment
To determine preliminary activity of i.v. LBH589 in combination with docetaxel and prednisone
Time frame: PK assessment will occur during the first 2 weeks of each pt 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 CLBH589C2205 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 Pharmaceuticals
9 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 (i.v. panobinostat) in people with Prostate Cancer, run by Novartis Pharmaceuticals at 9 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 4 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 9 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?
To determine the MTD of i.v. LBH589 in combination with docetaxel and prednisone in patients with HRPC (time frame: determine if MTD occurs after every 3 - 6 pts). 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.