Leukemia, Myeloid, AcutePhase 1/2NCT00691938
LBH589 Plus Decitabine for Myelodysplastic Syndromes (MDS) or Acute Myeloid Leukemia (AML)
A Phase 1/2 study testing LBH589 and Decitabine in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
- What is being tested?
- LBH589 and Decitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Aug 2014
- Phase
- Phase 1/2
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AML (except t(15;17), inv(16) or t(8;21) and variants) or high risk MDS (IPSS Int-2 or High) diagnosed according to WHO criteria (see Appendix 1)
- Age ≥ 60 years old
- Not a candidate for allogeneic stem cell transplantation within next 12 weeks
- Ability to provide written informed consent, obtained prior to participation in the study and any related procedures being performed
- Patients must meet the following laboratory criteria:
- Serum albumin ≥ 3 g/dL
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- Aspartate aminotransferase (AST)/SGOT and alanine aminotransferase (ALT)/SGPT ≤ 2.5 x upper limit of normal (ULN) ) or ≤ 5.0 x ULN if the transaminase elevation is due to leukemic involvement
- Serum bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
- Serum potassium ≥ lower limit of normal (LLN)
- Serum phosphorus ≥ LLN
- Serum total calcium (corrected for serum albumin) or serum ionized calcium ≥ LLN
- Serum magnesium ≥ LLN, thyroid stimulating hormone (TSH) and free thyroxine (T4) within normal limits (WNL) (patients may be on thyroid hormone replacement)
- Baseline MUGA or ECHO must demonstrate left ventricular ejection fraction (LVEF) ≥ the lower limit of the institutional normal.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
Who cannot join
- Prior treatment for MDS / AML with Histone deacetylase (HDAC) inhibitor or hypomethylating agent (e.g., Decitabine, azacitidine etc.)
- Active central nervous system (CNS) involvement with MDS/AML
- Impaired cardiac function including any one of the following:
- Screening electrocardiogram (ECG) with a QTc > 450 msec confirmed by central laboratory prior to enrollment to the study
- Patients with congenital long QT syndrome
- History of sustained ventricular tachycardia
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- Any history of ventricular fibrillation or torsades de pointes
- Bradycardia defined as heart rate < 50 beats per minute. Patients with a pacemaker and heart rate ≥ 50 beats per minute are eligible.
- Patients with a myocardial infarction or unstable angina within 6 months of study entry
- Congestive heart failure (NY Heart Association class III or IV)
- Right bundle branch block and left anterior hemiblock (bifasicular block)
- Uncontrolled hypertension
- Concomitant use of drugs with a risk of causing torsades de pointes
- Patients with unresolved diarrhea > CTCAE grade 1
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
- Other concurrent severe and/or uncontrolled medical conditions
- Patients who have received chemotherapy or any investigational drug < 2 weeks or hydroxyurea < 48 hours prior to starting study drug or who have not recovered from side effects of such therapy.
- Concomitant use of any anti-cancer therapy or radiation therapy
- Male patients whose sexual partners are women of child bearing potential (WOCBP) not using effective birth control
- Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C; baseline testing for HIV and hepatitis C is not required
- Patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent
- Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment
- Patients who have received targeted agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies
- Patients who have undergone major surgery ≤ 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study of LBH589 Plus Decitabine for Patients Age ≥ 60 Years With High Risk MDS or AML
This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia.
Read the detailed description
To address the need for less toxic, more effective treatments for older patients with advanced MDS and AML, the purpose of this Phase 1-2 single institution study is to evaluate the safety and efficacy of LBH 589 and decitabine administered in combination.
Decitabine is an epigenetic modifier of gene expression that has been shown to be well-tolerated in this population at the dose schedule proposed in this study, with reasonable efficacy. Although its precise mechanism of action is incompletely understood, it is postulated to work by reactivating the expression of key tumor suppressor genes silenced in tumor cells by reversing a pattern of hypermethylation of promotor elements.
LBH389 is likewise an epigenetic modifier that inhibits the deacetylation of both histones and non-histone proteins, including HSP90 and p53. Although clinical experience with LBH589 in AML is limited, aberrant histone deacetylase activity has been previously shown to play a significant role in the pathogenesis of AML. The addition of LBH589 to a decitabine regimen of previously established efficacy and tolerability will allow us to evaluate the hypothesis that two epigenetic modifiers that are believed to work through distinct mechanisms of action may act together to improve the responses of patients treated with decitabine alone, without significant additional toxicity.
- Being tested
- LBH589, Decitabine
- Keywords
- LBH589, Decitabine, panobinostat, histone deacetylase, methylation, hypomethylation
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBH589Drug
Also called Panobinostat
DecitabineDrug
Also called Dacogen, 5-aza-2'-deoxycytidine
| Study group | Role | What they receive |
|---|---|---|
| Level 1 | Experimental | LBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. Receives: Drug: LBH589; Drug: Decitabine |
| Level 2 | Experimental | LBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. Receives: Drug: LBH589; Drug: Decitabine |
| Level 3 | Experimental | LBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. Receives: Drug: LBH589; Drug: Decitabine |
| Level 4 | Experimental | LBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. Receives: Drug: LBH589; Drug: Decitabine |
| Level 5 | Experimental | LBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle.
Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. Receives: Drug: LBH589; Drug: Decitabine |
| Level 5B | Experimental | LBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle.
Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. Receives: Drug: LBH589; Drug: Decitabine |
| Phase II | Experimental | LBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was Level 5B.
Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. Receives: Drug: LBH589; Drug: Decitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine
Measured: Completion of Phase I enrollment for MTD (approximately 26 months)
Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)
- Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL.
- Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.
- Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL).
Measured: Up to 12 months
Secondary outcomes (10)
Rate of Cytogenetic Complete Remission (CRc)
Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics.
Measured: Up to 12 months
Changes in Quality of Life Scores as Measured by the Function Assessment of Cancer Therapy-Leukemia (FACT-Leu) Version 4
-The FACT-Leu consists of a 27-item compilation of general questions divided into four primary quality of life domains: physical well-being, social/family well being, emotional well-being, and functional well-being along with a 17 item subscale developed specifically for patients with leukemia.
Measured: Up to approximately 12 months after start of treatment
Time to Response
Time to response is defined as the date of the first dose of study drug to the date that all criteria for CR or CRi are fulfilled.
Measured: Up to 12 months
Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced
Adverse events will be assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 3.0.
Measured: Up to 13 months after start of treatment
Remission Duration
Defined as the first date that all criteria for CR, CRi or HI are fulfilled to the date of treatment failure, relapse from CR, or death due to any cause.
Measured: Completion of follow-up (median follow-up was 58 months)
Progression-free Survival
Measured: Completion of follow-up (median follow-up was 58 months)
Event-free Survival
Event-free survival is defined as the interval from the date of first dose of study drug to date of treatment failure, relapse from CR, or death due to any cause.
Measured: Completion of follow-up (median follow-up was 58 months)
Overall Survival
Overall survival is defined as the date of first dose of study drug to the date of death from any cause.
Measured: Completion of follow-up (median follow-up was 58 months)
Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)
Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL).
Measured: Up to 12 months
Rate of Hematologic Improvement.
-Hematologic improvement (HI). Includes the following categories:
- Erythroid response: Hemoglobin increase by ≥ 1.5 g/dL over baseline in which the pretreatment hemoglobin is < 11 g/dL or reduction of RBC transfusions of at least 4 RBC transfusions / 8 wk compared with the pretreatment transfusion number in the previous 8 weeks.
- Platelet response. Absolute increase of > 30 x 10^9/L for patients starting with 20 x 10^9/L or increase from < 20 x 10^9/L to > 20 x 109/L and by at least 100%
- Neutrophil response. At least 100% increase and an absolute increase > 0.5 x 109/L for patients with pretreatment neutrophils < 1.0 x 109/L)
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJul 2013
- Study completionAug 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geoffrey Uy, M.D., Principal investigator, Washington Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691938
- Sponsor's protocol ID
- 08-0172 / 201012979
- Status last verified
- Aug 2016
- First submitted
- 4 Jun 2008
- Last updated
- 13 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cashen, A., G. J. Schiller, et al. (2006). Phase II Study of Low-Dose Decitabine for the Front-Line Treatment of Older Patients with Acute Myeloid Leukemia (AML). ASH Annual Meeting Abstracts 108(11): 1984.
Uy GL, Duncavage EJ, Chang GS, Jacoby MA, Miller CA, Shao J, Heath S, Elliott K, Reineck T, Fulton RS, Fronick CC, O'Laughlin M, Ganel L, Abboud CN, Cashen AF, DiPersio JF, Wilson RK, Link DC, Welch JS, Ley TJ, Graubert TA, Westervelt P, Walter MJ. Dynamic changes in the clonal structure of MDS and AML in response to epigenetic therapy. Leukemia. 2017 Apr;31(4):872-881. doi: 10.1038/leu.2016.282. Epub 2016 Oct 14.
PubMed 27740633
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of LBH589 Plus Decitabine for Patients Age ≥ 60 Years With High Risk MDS or AML
- ClinicalTrials.gov ID
- NCT00691938
- Acronym / sponsor ID
- 08-0172 / 201012979
- Keywords
- LBH589, Decitabine, panobinostat, histone deacetylase, methylation, hypomethylation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 13 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the combination of LBH589 and decitabine in patients age ≥ 60 years with high risk Myelodysplastic Syndrome (IPSS Int-2 or High) or Acute Myeloid Leukemia.
Detailed description
To address the need for less toxic, more effective treatments for older patients with advanced MDS and AML, the purpose of this Phase 1-2 single institution study is to evaluate the safety and efficacy of LBH 589 and decitabine administered in combination.
Decitabine is an epigenetic modifier of gene expression that has been shown to be well-tolerated in this population at the dose schedule proposed in this study, with reasonable efficacy. Although its precise mechanism of action is incompletely understood, it is postulated to work by reactivating the expression of key tumor suppressor genes silenced in tumor cells by reversing a pattern of hypermethylation of promotor elements.
LBH389 is likewise an epigenetic modifier that inhibits the deacetylation of both histones and non-histone proteins, including HSP90 and p53. Although clinical experience with LBH589 in AML is limited, aberrant histone deacetylase activity has been previously shown to play a significant role in the pathogenesis of AML. The addition of LBH589 to a decitabine regimen of previously established efficacy and tolerability will allow us to evaluate the hypothesis that two epigenetic modifiers that are believed to work through distinct mechanisms of action may act together to improve the responses of patients treated with decitabine alone, without significant additional toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Level 1 | Experimental | Drug: LBH589, Drug: DecitabineLBH589 10 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. |
| Level 2 | Experimental | Drug: LBH589, Drug: DecitabineLBH589 15 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. |
| Level 3 | Experimental | Drug: LBH589, Drug: DecitabineLBH589 20 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. |
| Level 4 | Experimental | Drug: LBH589, Drug: DecitabineLBH589 30 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. |
| Level 5 | Experimental | Drug: LBH589, Drug: DecitabineLBH589 40 mg/day three times a week on nonconsecutive days in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. |
| Level 5B | Experimental | Drug: LBH589, Drug: DecitabineLBH589 40 mg/day three times a week on nonconsecutive days for the first 2 weeks in a 28 day cycle. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. |
| Phase II | Experimental | Drug: LBH589, Drug: DecitabineLBH589 will be given in the dose and in the schedule that was found to work in the Phase I portion which was Level 5B. Decitabine 20 mg/m^2 IV on days 1-5 in a 28 day cycle. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- AML (except t(15;17), inv(16) or t(8;21) and variants) or high risk MDS (IPSS Int-2 or High) diagnosed according to WHO criteria (see Appendix 1)
- Age ≥ 60 years old
- Not a candidate for allogeneic stem cell transplantation within next 12 weeks
- Ability to provide written informed consent, obtained prior to participation in the study and any related procedures being performed
- Patients must meet the following laboratory criteria:
Key exclusion criteria (24 listed)
- Prior treatment for MDS / AML with Histone deacetylase (HDAC) inhibitor or hypomethylating agent (e.g., Decitabine, azacitidine etc.)
- Active central nervous system (CNS) involvement with MDS/AML
- Impaired cardiac function including any one of the following:
- Screening electrocardiogram (ECG) with a QTc > 450 msec confirmed by central laboratory prior to enrollment to the study
- Patients with congenital long QT syndrome
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 |
|---|---|---|
| LBH589Also: Panobinostat | Drug | Level 1, Level 2, Level 3, Level 4, Level 5, Level 5B, Phase II |
| DecitabineAlso: Dacogen, 5-aza-2'-deoxycytidine | Drug | Level 1, Level 2, Level 3, Level 4, Level 5, Level 5B, Phase II |
Primary outcome
Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine
Time frame: Completion of Phase I enrollment for MTD (approximately 26 months)
Phase II: Overall Rate of Morphologic Complete Remission (CR) + Cytogenetic Complete Remission (CRc) + Morphologic Complete Remission With Incomplete Blood Count Recovery (CRi)
Time frame: Up to 12 months
* Morphologic complete remission (CR). A CR designation requires that the patient achieve the morphologic leukemia-free state with less than 5% blasts in an aspirate sample with marrow spicules and with a count of at least 200 nucleated cells. There should be no blasts with Auer rods or persistence of extramedullary disease. Patients must also have an absolute neutrophil count of more than 1,000/μLand platelets of 100,000/μL. * Cytogenetic complete remission (CRc). A CRc will be defined by the achievement of a CR with reversion to a normal karyotype in a minimum of 20 metaphases analyzed by cytogenetics. * Morphologic complete remission with incomplete blood count recovery (CRi): Achievement of all of the criteria for CR except for residual neutropenia (< 1,000/μL) or thrombocytopenia (< 100,000/μL).
10 secondary outcomes
Rate of Cytogenetic Complete Remission (CRc)
Time frame: Up to 12 months
Changes in Quality of Life Scores as Measured by the Function Assessment of Cancer Therapy-Leukemia (FACT-Leu) Version 4
Time frame: Up to approximately 12 months after start of treatment
Time to Response
Time frame: Up to 12 months
Safety and Tolerability of Regimen as Measured by the Rate of the Most Common Adverse Events Experienced
Time frame: Up to 13 months after start of treatment
Remission Duration
Time frame: Completion of follow-up (median follow-up was 58 months)
Progression-free Survival
Time frame: Completion of follow-up (median follow-up was 58 months)
Event-free Survival
Time frame: Completion of follow-up (median follow-up was 58 months)
Overall Survival
Time frame: Completion of follow-up (median follow-up was 58 months)
Rates of Morphologic Complete Remission With Incomplete Count Recovery (CRi)
Time frame: Up to 12 months
Rate of Hematologic Improvement.
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundCashen, A., G. J. Schiller, et al. (2006). Phase II Study of Low-Dose Decitabine for the Front-Line Treatment of Older Patients with Acute Myeloid Leukemia (AML). ASH Annual Meeting Abstracts 108(11): 1984.
- Derived from this study: PubMed 27740633Uy GL, Duncavage EJ, Chang GS, Jacoby MA, Miller CA, Shao J, Heath S, Elliott K, Reineck T, Fulton RS, Fronick CC, O'Laughlin M, Ganel L, Abboud CN, Cashen AF, DiPersio JF, Wilson RK, Link DC, Welch JS, Ley TJ, Graubert TA, Westervelt P, Walter MJ. Dynamic changes in the clonal structure of MDS and AML in response to epigenetic therapy. Leukemia. 2017 Apr;31(4):872-881. doi: 10.1038/leu.2016.282. Epub 2016 Oct 14.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Geoffrey Uy, M.D. principal investigator
Washington Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LBH589 and Decitabine in people with Leukemia, Myeloid, Acute and Myelodysplastic Syndromes, run by Washington University School of Medicine at 1 site 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 15 inclusion and 24 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 13 Oct 2016. 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 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 combined 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.
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 13 Oct 2016). 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?
Phase I: Maximum Tolerated Dose (MTD) of LBH589 When Given in Combination With Decitabine (time frame: Completion of Phase I enrollment for MTD (approximately 26 months)). 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?
On the ClinicalTrials.gov record for NCT00691938, which also lists 2 linked publications.
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 13 Oct 2016.