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Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase
Phase 2 trial testing LBH589 in Leukemia, Myeloid, Chronic in 27 participants. Terminated before completion.
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 23 February 2007 |
| Primary completion | 29 January 2008 |
| Estimated completion | 26 August 2008 |
| Sites | 26 locations across United States, Germany |
Novartis Pharmaceuticals — full company profile →
18 and older, any sex, with Leukemia, Myeloid, Chronic. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary efficacy variable was hematologic response, a composite endpoint defined as the overall of complete hematologic response (CHR), and of no evidence of leukemia (NEL) and of the return to chronic phase (RTC).
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 0 |
A fusion gene of the BCR and ABL genes (BCR-ABL) messenger ribose nucleic acid (mRNA) expression (molecular response) was performed by quantitative polymerase chain reaction (qPCR) and mutational analysis was performed by direct sequencing technology, and both analyses were performed by Genzyme.
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 0 |
Tmax is defined as the time at which the Cmax occurs. It will be obtained from the Tmax parameter calculated by WinNonlin®. If there is no measurable Cmax in the subject's Pharmacokinetic (PK) profile, then Tmax will be missing for that subject. Tmax will be reported in units of h.
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 1.5 | 0.2 – 3.4 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 1.5 | 1.0 – 3.4 |
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations. It will be obtained from the Cmax parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Cmax will be missing for that subject. Cmax will be reported in units of ng/mL.
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 13.5 | ± 7.0 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 20.9 | ± 15.0 |
Area under the curve (AUC) is defined as the area under concentration-time curve as a measure of drug exposure. The area under the plasma concentration-time curve from time zero to 24 hours.
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 139 | ± 61 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 148 | ± 69 |
Clast is defined as the Last observed (quantifiable) plasma concentration (Clast), in units of ng/mL. Blood samples were collected to assess Clast.
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 1.9 | ± 2.4 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 4.7 | ± 8.2 |
Time of Clast (Tlast) will be obtained from the Tlast parameter calculated by WinNonlin®. If there is no measurable concentration in the subject's PK profile, then Tlast will be missing for that participants. Tlast will be reported in units of h.
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 23.9 | 3.1 – 49.2 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 24.1 | 2.2 – 27.0 |
QTc monitoring was performed on specified days (Cycle1: Day1, 5 and 26), as well as a single pre-dose ECG once weekly during Cycle1: Week2 and Week3, Cycle2, and all subsequent cycles. Patient eligibility was ensured by a screening QTcF interval calculated by eResearchTechnology(eRT) prior to the baseline assessments. Treatment decisions were based on QTc determined by the automated reading at the investigational site (commonly used the Bazett's correction,QTcB) or measured and calculated by trained personnel at the site. Dosing relied on the investigator's assessment of the 6 baseline ECGs (t
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 396.6 | ± 20.10 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 24.5 | ± 9.58 |
Adverse Events (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazar
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 27 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 16 |
| Group | Value | 95% CI |
|---|---|---|
| Panobinostat | 13 |
Time frame: From Start of the Study up to Study Termination (approximately up to 18 Months).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Panobinostat |
|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Pyrexia | General disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Catheter site haemorrhage | General disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Haemorrhagic diathesis | Blood and lymphatic system disorders | — |
| Asthenia | General disorders | — |
| General physical health deterioration | General disorders | — |
| Pneumonia | Infections and infestations | — |
| Pseudomonal bacteraemia | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | — |
| Subdural haematoma | Injury, poisoning and procedural complications | — |
| Platelet count decreased | Investigations | — |
| White blood cell count increased | Investigations | — |
| Central nervous system leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Aphasia | Nervous system disorders | — |
| Cerebral haemorrhage | Nervous system disorders | — |
| Cerebral infarction | Nervous system disorders | — |
| Coma | Nervous system disorders | — |
| Haemorrhagic cerebral infarction | Nervous system disorders | — |
| Syncope | Nervous system disorders | — |
| Mental status changes | Psychiatric disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Panobinostat |
|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Pyrexia | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Hyperuricaemia | Metabolism and nutrition disorders | — |
| Hypokalaemia | Metabolism and nutrition disorders | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Oedema peripheral | General disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Tachycardia | Cardiac disorders | — |
| Abdominal pain upper | Gastrointestinal disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Asthenia | General disorders | — |
| Fatigue | General disorders | — |
| Pain | General disorders | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Neutropenia | Blood and lymphatic system disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Chills | General disorders | — |
| Bacteraemia | Infections and infestations | — |
| Pneumonia | Infections and infestations | — |
| Upper respiratory tract infection | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| White blood cell count increased | Investigations | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — |
| Bone pain | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
| Headache | Nervous system disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Urinary incontinence | Renal and urinary disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Thrombocytopenia, Pyrexia, Neutropenia, Catheter site haemorrhage, Febrile neutropenia, Haemorrhagic diathesis, Asthenia, General physical health deterioration.
Data from ClinicalTrials.gov NCT00449761 adverse events section.
This study will evaluate the efficacy and safety of LBH589B in adult patients with chronic myeloid leukemia who are in accelerated phase or blast phase (blast crisis) with resistant disease following treatment with at least two BCR-ABL tyrosine kinase inhibitors
7 peer-reviewed publications reference this trial (live from Europe PMC):
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