Hormone Refractory Prostate CancerPhase 1NCT00493766
Safety of LBH589 Alone and in Combination With IV Docetaxel and Prednisone
A Phase 1 study testing LBH589 in people with Hormone Refractory Prostate Cancer, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hormone Refractory Prostate Cancer
- What is being tested?
- LBH589
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2006to Jul 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 documented adenocarcinoma of the prostate.
- Patients must have metastatic disease with at least one measurable soft tissue lesion that can be assessed by computerized tomography (CT), or magnetic resonance imaging (MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated prostate specific antegen (PSA) levels are not eligible for entry.
- Patients who have undergone medical castration must continue Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment
- Patients must be able to provide written informed consent
Who cannot join
- Patients with prior or concurrent brain metastases
- Impaired cardiac, gastrointestinal, kidney, or liver function
- Use of therapeutic androgens
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dana Farber Cancer Institute
Boston, Massachusetts, 02115-6-84
Duke University Medical Center
Durham, North Carolina, 27705
Nevada Cancer Institute
Las Vegas, Nevada, 89135
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Washing University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)
This is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile
- Conditions
- Hormone Refractory Prostate Cancer
- Being tested
- LBH589
- Keywords
- LBH589, Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
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 |
|---|---|---|
| oral LBH589 alone | Experimental | Not described Receives: Drug: LBH589 |
| oral LBH589 + IV docetaxel + oral prednisone | Experimental | Not described Receives: Drug: LBH589 |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC.
Measured: at study start and at study end
• To determine the MTD and DLT of escalating doses of LBH589 in combination with a stan-dard dose of docetaxel q3wks and daily Prednisone® in adult men with HRPC.
Measured: at study start and at study end
Secondary outcomes (2)
• To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities
Measured: at study start and at study end
• To characterize the single-dose and multidose pharmacokinetic (PK) profiles of LBH589 alone and in combination with docetaxel and Prednisone®. To characterize the PK profiles of docetaxel alone and in combination with LBH589.
Measured: at study start and at study end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startMay 2006
- Primary completionJul 2008
Why it stopped: Because of a strategic decision by Novartis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone Refractory 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT00493766
- Sponsor's protocol ID
- CLBH589B2105
- Status last verified
- Nov 2012
- First submitted
- 26 Jun 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 IA/IB, Two Arm, Multi-center, Open-label, Dose Escalation Study of Oral LBH589 Alone and in Combination With IV Docetaxel and Oral Prednisone in Hormone Refractory Prostate Cancer (HRPC)
- ClinicalTrials.gov ID
- NCT00493766
- Acronym / sponsor ID
- CLBH589B2105
- Conditions
- Hormone Refractory Prostate Cancer
- Keywords
- LBH589, Prostate Cancer, HRPC, Hormone Refractory Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of a strategic decision by Novartis
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2008 (actual)
- First posted
- 28 Jun 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 is a parallel, two-arm, open-label, multicenter phase IA/IB study of LBH589 (oral formulation) alone and in combination with docetaxel in patients with progressing hormone refractory prostate cancer. This study is designed to determine the maximum tolerated dose of LBH589 as a single agent and in combination with docetaxel and prednisone 5 mg two times a day , and to characterize the safety, tolerability, biologic activity and pharmacokinetic profile
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral LBH589 alone | Experimental | Drug: LBH589 |
| oral LBH589 + IV docetaxel + oral prednisone | 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 (4 listed)
- Histologically documented adenocarcinoma of the prostate.
- Patients must have metastatic disease with at least one measurable soft tissue lesion that can be assessed by computerized tomography (CT), or magnetic resonance imaging (MRI) and/or detectable lesion(s) on bone scintigraphy scan. Patients with only elevated prostate specific antegen (PSA) levels are not eligible for entry.
- Patients who have undergone medical castration must continue Luteinizing hormone-releasing hormone (LHRH) agonist or antagonist therapy during study treatment
- Patients must be able to provide written informed consent
Key exclusion criteria (4 listed)
- Patients with prior or concurrent brain metastases
- Impaired cardiac, gastrointestinal, kidney, or liver function
- Use of therapeutic androgens
- 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 |
|---|---|---|
| LBH589 | Drug | oral LBH589 + IV docetaxel + oral prednisone, oral LBH589 alone |
Primary outcome
• To determine the maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC.
Time frame: at study start and at study end
• To determine the MTD and DLT of escalating doses of LBH589 in combination with a stan-dard dose of docetaxel q3wks and daily Prednisone® in adult men with HRPC.
Time frame: at study start and at study end
2 secondary outcomes
• To characterize the safety and tolerability of LBH589 alone and in combination with do-cetaxel and Prednisone® including acute and chronic toxicities
Time frame: at study start and at study end
• To characterize the single-dose and multidose pharmacokinetic (PK) profiles of LBH589 alone and in combination with docetaxel and Prednisone®. To characterize the PK profiles of docetaxel alone and in combination with LBH589.
Time frame: at study start and at study end
Results and safety
The study was stopped early (reason given: Because of a strategic decision by Novartis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CLBH589B2105 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
Related trials for Hormone Refractory Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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 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 Hormone Refractory Prostate Cancer, run by Novartis Pharmaceuticals at 5 sites 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 4 inclusion and 4 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: stopped early, 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. 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 was stopped early (reason given: Because of a strategic decision by Novartis). Results are not available in the source record.
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 maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT) of esca-lating doses of LBH589 in adult men with HRPC. (time frame: at study start and at study end). The study lists 2 primary outcomes in all. 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.