Phase 2
N=176
A Study of Oral LBH589 in Adult Patients With Advanced Hematological Malignancies
Lymphoma · Leukemia · Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00621244 ↗Enrolled (actual)
176
Serious AEs
69.9%
Results posted
Aug 2017
Primary outcome: Primary: Number of Participants DLT in Arm 1 in Dose Escalation Phase — 0; 0; 2; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LBH589 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants DLT in Arm 1 in Dose Escalation Phase |
0; 0; 2; 1; 4; 0 | — |
| PRIMARY Number of Participants DLT in Arm 2 in Dose Escalation Phase |
0; 0; 0; 4; 0; 0 | — |
| SECONDARY Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) |
2; 0; 1; 1; 25; 10 | — |
| SECONDARY Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase |
1; 5; 6; 2; 5 | — |
| SECONDARY Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) |
1; 1; 4; 3; 11; 4 | — |
| SECONDARY Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) |
0; 0; 4; 1; 4; 0 | — |
| SECONDARY Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 |
19.5; 39.8; 58; 54; 66.9; 63.5 | — |
| SECONDARY Half Life of Panobinostat After the First Dose in Arms 1 and 2 |
13.8; 18.2; 13.6; 19.7; 15.4; 14.6 | — |
| SECONDARY Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 |
33.6; 38.4; 41.6; 51.8; 69.6 | — |
| SECONDARY Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 |
20.1; 19.7; 21.4; 17.9; 17.7 | — |
| SECONDARY Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 |
2.16; 1.07; 0.98; 1.17; 1.12; 1.86 | — |
| SECONDARY Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X |
NA; 100.0; NA; NA; NA; 100.0 | — |
| SECONDARY Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y |
100.0; 100.0; 66.7; 75.0; 100.0; 100.0 | — |
| SECONDARY Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X |
50.0; 88.9; 83.3; 100.0; 50.0; 100.0 | — |
| SECONDARY Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y |
100.0; 100.0; 100.0; 100.0; 100.0; 83.3 | — |
| SECONDARY Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) |
56.6; 22.5; 63.2; 591.4; 31; 66.7 | — |
| SECONDARY Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) |
96.2; 67.7; 59.3; 34.2; 0.0; 200.7 | — |
Summary
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
Eligibility Criteria
Inclusion criteria
- Adult patients (≥18 years old) with advanced hematological malignancies who relapsed after or are refractory to standard therapy, or for which no standard therapy existed; or, were considered inappropriate candidates for standard therapy
- World Health Organization (WHO) performance status ≤ 2
- Patients who met protocol-specified hematologic and non-hematologic laboratory values
- Patients with adequate liver and renal function
Exclusion criteria
- Concurrent brain metastases or leukemic infiltration of the cerebrospinal fluid
- Peripheral neuropathy ≥ CTCAE grade 2
- Unresolved diarrhea ≥ CTCAE grade 2
- Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study, including impaired heart function or clinically significant heart disease, and impaired gastrointestinal function or disease that significantly altered aborption of LBH589
- Female patients who were pregnant or breast feeding
- Patients who were unwilling to use an effective method of birth control
- Patients who took medications specified by the protocol as prohibited for administration in combination with LBH589
- Patients with another primary malignancy that required active intervention or were clinically significant
Data sourced from ClinicalTrials.gov (NCT00621244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.