Prostate CancerPhase 2NCT00667862
Efficacy and Safety Study of Panobinostat in Participants With Metastatic Hormone Refractory Prostate Cancer
A Phase 2 study testing Panobinostat in people with Prostate Cancer, run by Novartis Pharmaceuticals at 5 sites in United States.
Trial summary
This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants 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?
- Panobinostat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Mar 2008to 5 Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Confirmed diagnosis of adenocarcinoma of the prostate
- Participants with metastatic hormone refractory prostate cancer
- Participants that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
- Evidence of disease progression by at least one of the following:
- two or more lesions on bone scan
- progressive measurable disease
- two documented increases in prostate-specific antigen (PSA)
- Willing to use contraception throughout the study and for 12 weeks after study completion
Who cannot join
- History or clinical signs of central nervous system (CNS) disease
- 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 function
- 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
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins Hospital
Baltimore, Maryland, 21287
University of Wisconsin
Madison, Wisconsin, 53706-1481
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University
St Louis, Missouri, 63130
About this study
Official title: A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer
This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Panobinostat
- Keywords
- Prostate, Cancer, Adenocarcinoma, Prostate-Specific Antigen, metastatic, male, HRPC, DACi
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Adenocarcinoma, Neoplasm Metastasis
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 |
|---|---|---|
| Panobinostat | Experimental | Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent. Receives: Drug: Panobinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks
The PFS rate was defined as the percentage of participants that were alive without documented disease progression at the end of 24 weeks from first study treatment. Disease Progression as per response evaluation criteria in solid tumors (RECIST) criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 centimeter (cm) at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of greater than or equal to (>=) 2 unequivocal new lesions confirmed on a second scan at least 6 weeks later.
Measured: 24 weeks
Secondary outcomes (7)
Percentage of Participants With Tumor Response Rate
The tumor response rate was defined as a percentage of participants with confirmed Complete Response (CR) or Partial Response (PR) per RECIST criteria. CR: Disappearance of all target lesions and all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters.
Measured: Every 12 weeks up to approximately 2.7 years
Percentage of Participants With Duration of Stable Disease (SD) Per RECIST
Duration of SD was the time from date of start of treatment to the date of event, defined as the first documented disease progression or death due to underlying cancer. Disease Progression as per RECIST criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 cm at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of >=2 unequivocal new lesions confirmed on a second scan at least 6 weeks later. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. CR: Disappearance of all target lesions and all nontarget lesions. PR: At least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. If a participant had not had an event, duration of SD was to be censored at the date of last assessment.
Measured: Every 12 weeks up to approximately 2.7 years
Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate at 24 Weeks
The PSA response was defined as a 50% decrease in PSA from baseline maintained for >= 4 weeks, and without clinical or radiographic evidence of disease progression during this time period. Disease Progression as per RECIST criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 cm at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of >= 2 unequivocal new lesions confirmed on a second scan at least 6 weeks later.
Measured: 24 weeks
Percentage of Participants With PSA Progression Rate at 24 Weeks
The PSA progression was defined as a 50% rise from nadir and a minimum rise of 2 nanogram per milligram (ng/mL). Disease Progression as per RECIST criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 cm at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of >=2 unequivocal new lesions confirmed on a second scan at least 6 weeks later.
Measured: 24 weeks
Median Progression-free Survival (PFS)
PFS was defined as the time from the date of start of treatment to the date of first documented disease progression or death due to any cause. If a participant had not had a disease progression and was alive, the participant was to be censored using the RECIST. Disease Progression as per RECIST criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 cm at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of >=2 unequivocal new lesions confirmed on a second scan at least 6 weeks later. Kaplan-Meier method was to be used to estimate the median PFS.
Measured: After every cycle up to approximately 2.7 years
Overall Survival
The overall survival was defined as the time from date of start of treatment to date of death due to any cause. If a participant was not known to have died, survival was to be censored at the date of last contact. Kaplan-Meier method was to be used to estimate overall survival.
Measured: Start of study treatment to date of death due to any cause (Up to approximately 2.7 years)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was an adverse medical event which occurs in a participant of the study and which is not necessarily in a causal relationship with the treatment the participant receives. SAEs were AEs leading to death, are life-threatening, require hospitalizations or prolongation of hospitalizations, represent an innate malformation or a congenital abnormality.
Measured: From start of the study up to at least 4 weeks following the last dose of study treatment (Up to approximately 2.7 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2008 (estimated)
- Study start18 Mar 2008
- Primary completion5 Nov 2010
- Study completion5 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT00667862
- Sponsor's protocol ID
- CLBH589C2208
- Other IDs
- 2007-004995-37
- Status last verified
- May 2021
- First submitted
- 18 Apr 2008
- Last updated
- 21 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Rathkopf DE, Picus J, Hussain A, Ellard S, Chi KN, Nydam T, Allen-Freda E, Mishra KK, Porro MG, Scher HI, Wilding G. A phase 2 study of intravenous panobinostat in patients with castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2013 Sep;72(3):537-44. doi: 10.1007/s00280-013-2224-8. Epub 2013 Jul 3.
PubMed 23820963
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open Label, Single Arm Study of i.v. Panobinostat (LBH589) in Patients With Metastatic Hormone Refractory Prostate Cancer
- ClinicalTrials.gov ID
- NCT00667862
- Acronym / sponsor ID
- CLBH589C2208
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, Adenocarcinoma, Prostate-Specific Antigen, metastatic, male, HRPC, DACi
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2008 (actual)
- Primary completion
- 5 Nov 2010 (actual)
- Study completion
- 5 Nov 2010 (actual)
- First posted
- 28 Apr 2008 (estimated)
- Results
- Posted 21 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants 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 |
|---|---|---|
| Panobinostat | Experimental | Drug: PanobinostatParticipants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of adenocarcinoma of the prostate
- Participants with metastatic hormone refractory prostate cancer
- Participants that have had at least one, but not more than two prior cytotoxic treatments for prostate cancer
- Evidence of disease progression by at least one of the following:
- Willing to use contraception throughout the study and for 12 weeks after study completion
Key exclusion criteria (8 listed)
- History or clinical signs of central nervous system (CNS) disease
- 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
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 | Panobinostat |
Primary outcome
Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks
Time frame: 24 weeks
The PFS rate was defined as the percentage of participants that were alive without documented disease progression at the end of 24 weeks from first study treatment. Disease Progression as per response evaluation criteria in solid tumors (RECIST) criteria: Measurable lesions: If target lesion was lymph node then it had to be at least 2 centimeter (cm) at baseline to assess change in size. Bone lesions: (non-target lesions) appearance of greater than or equal to (>=) 2 unequivocal new lesions confirmed on a second scan at least 6 weeks later.
7 secondary outcomes
Percentage of Participants With Tumor Response Rate
Time frame: Every 12 weeks up to approximately 2.7 years
Percentage of Participants With Duration of Stable Disease (SD) Per RECIST
Time frame: Every 12 weeks up to approximately 2.7 years
Percentage of Participants With Prostate Specific Antigen (PSA) Response Rate at 24 Weeks
Time frame: 24 weeks
Percentage of Participants With PSA Progression Rate at 24 Weeks
Time frame: 24 weeks
Median Progression-free Survival (PFS)
Time frame: After every cycle up to approximately 2.7 years
Overall Survival
Time frame: Start of study treatment to date of death due to any cause (Up to approximately 2.7 years)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From start of the study up to at least 4 weeks following the last dose of study treatment (Up to approximately 2.7 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23820963Rathkopf DE, Picus J, Hussain A, Ellard S, Chi KN, Nydam T, Allen-Freda E, Mishra KK, Porro MG, Scher HI, Wilding G. A phase 2 study of intravenous panobinostat in patients with castration-resistant prostate cancer. Cancer Chemother Pharmacol. 2013 Sep;72(3):537-44. doi: 10.1007/s00280-013-2224-8. Epub 2013 Jul 3.
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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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Panobinostat in people with 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 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 21 Jun 2021. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Progression-Free Survival (PFS) Rate at 24 Weeks (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00667862, which also lists 1 linked publication.
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 21 Jun 2021.