Leukemia, Lymphoma, Multiple Myeloma
Conditions
Keywords
HDAC inhibitor, Oral, LBH589, Lymphoma, Leukemia, Multiple myeloma
Brief summary
This study evaluated safety, tolerability, pharmacokinetics and preliminary anti-leukemic or anti-tumor activity of LBH589B in adult patients with advanced hematological malignancies
Interventions
DRUGLBH589
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants DLT in Arm 1 in Dose Escalation Phase | Cycle 1 (28-day treatment cycle) | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. |
| Number of Participants DLT in Arm 2 in Dose Escalation Phase | Cycle 1 (28-day treamtent cycle) | Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | 3.5 years | Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure. |
| Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | 3.5 years | Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission. |
| Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | Day 1 | — |
| Half Life of Panobinostat After the First Dose in Arms 1 and 2 | Day 1 | — |
| Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | Day 15 | From day 15 by dose with schedule: MWF every week |
| Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | Day 15 | — |
| Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | 3.5 years | Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease. |
| Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Days 1, 5, 8, 10, 15 | Reporting the number of patients with a reading at the timepoint in the dose group. |
| Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Days 5, 8, end of study (up to 3.5 years) | — |
| Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years) | — |
| Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Days 5, 8, 10, 12, 15, End of study (up to 3.5 years) | — |
| Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | Post dose to pre-dose (up to 3.5 years) | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\])) |
| Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | Post dose to pre-dose (up to 3.5 years) | All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\])) |
| Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | Day 15/day 1 | MWF Every week schedule n = number of subjects with non-missing values. |
| Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase | 1.2 years | Stage 2 did not open for enrollment. |
Countries
Australia, Germany, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1, Group X panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | 86 |
| Arm 1, Group Y panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. | 34 |
| Arm 2, Group X panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group X indications (AML, CML-BC, AP, CP, ALL, MDS (RAEB-1, -2), MMM, CMML, aCML, CLL, and PLL) is a sub-arm, based on disease indication. | 33 |
| Arm 2, Group Y panobinostat was administered orally, once-a-day, on Monday-Wednesday-Friday (MWF), every other week, as part of a 28-day treatment cycle. Group Y indications (MM, HL, and NHL) is a sub-arm, based on disease indication. | 23 |
| Total | 176 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative problems | 5 | 1 | 0 | 2 |
| Overall Study | Adverse Event | 27 | 7 | 9 | 2 |
| Overall Study | Death | 3 | 3 | 1 | 1 |
| Overall Study | Disease progression | 44 | 20 | 20 | 15 |
| Overall Study | Withdrawal by Subject | 7 | 3 | 3 | 3 |
Baseline characteristics
| Characteristic | Arm 1, Group X | Arm 1, Group Y | Arm 2, Group X | Arm 2, Group Y | Total |
|---|---|---|---|---|---|
| Age, Continuous | 64.2 years STANDARD_DEVIATION 12.11 | 41.1 years STANDARD_DEVIATION 17.27 | 68.7 years STANDARD_DEVIATION 8.75 | 48.3 years STANDARD_DEVIATION 17.41 | 58.5 years STANDARD_DEVIATION 16.97 |
| Sex: Female, Male Female | 31 Participants | 13 Participants | 12 Participants | 5 Participants | 61 Participants |
| Sex: Female, Male Male | 55 Participants | 21 Participants | 21 Participants | 18 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 8 / 8 | 8 / 8 | 10 / 10 | 49 / 49 | 11 / 11 | 1 / 1 | 4 / 4 | 24 / 24 | 5 / 5 | 6 / 6 | 9 / 9 | 9 / 9 | 9 / 9 | 1 / 1 | 7 / 7 | 15 / 15 |
| serious Total, serious adverse events | 8 / 8 | 5 / 8 | 9 / 10 | 34 / 49 | 10 / 11 | 0 / 1 | 3 / 4 | 10 / 24 | 2 / 5 | 5 / 6 | 8 / 9 | 7 / 9 | 8 / 9 | 0 / 1 | 3 / 7 | 11 / 15 |
Outcome results
Primary
Number of Participants DLT in Arm 1 in Dose Escalation Phase
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for consecutive dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Time frame: Cycle 1 (28-day treatment cycle)
Population: MTD-determining set: Patients in the safety set who were in the dose escalation phase, and who received panobinostat for ≥ 9 full doses in arm 1 in cycle 1 and completed all needed safety evaluations; or who received panobinostat for ≥ 5 full doses in arm 2 in cycle 1 and completed all required safety evaluations; or who experienced DLT in cycle 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1, Group X (20 mg) | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group X (30 mg) | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group X (40 mg) | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 2 Participants |
| Arm 1, Group X (60 mg) - MTD | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 1 Participants |
| Arm 1, Group X (80 mg) | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 4 Participants |
| Arm 1, Group Y (20 mg) | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group Y (30 mg) | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group Y (40 mg) - MTD | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 5 Participants |
| Arm 1, Group Y (60 mg) | Number of Participants DLT in Arm 1 in Dose Escalation Phase | 4 Participants |
Primary
Number of Participants DLT in Arm 2 in Dose Escalation Phase
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) for intermittent dosing schedule (MWF weekly). A 3-parameter version of a Bayesian logistic regression model with overdose control (Babb, Rogatko, and Zacks 1998) was used during the dose escalation phase for dose level selection and determination of the MTD.
Time frame: Cycle 1 (28-day treamtent cycle)
Population: MTD-determining population: All patients from the safety population who were in the dose escalation phase of the study, and who received panobinostat for ≥ 9 full doses in arm 1 during cycle 1 and completed all required safety evaluations; or who received panobinostat.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1, Group X (20 mg) | Number of Participants DLT in Arm 2 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group X (30 mg) | Number of Participants DLT in Arm 2 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group X (40 mg) | Number of Participants DLT in Arm 2 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group X (60 mg) - MTD | Number of Participants DLT in Arm 2 in Dose Escalation Phase | 4 Participants |
| Arm 1, Group X (80 mg) | Number of Participants DLT in Arm 2 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group Y (20 mg) | Number of Participants DLT in Arm 2 in Dose Escalation Phase | 0 Participants |
| Arm 1, Group Y (30 mg) | Number of Participants DLT in Arm 2 in Dose Escalation Phase | 3 Participants |
Secondary
Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1
MWF Every week schedule n = number of subjects with non-missing values.
Time frame: Day 15/day 1
Population: Pharmacokinetic set
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | AUC | 2.16 Ratio |
| Arm 1, Group X (20 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | C (max) N=8,12,18,17,4 | 1.86 Ratio |
| Arm 1, Group X (30 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | AUC | 1.07 Ratio |
| Arm 1, Group X (30 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | C (max) N=8,12,18,17,4 | 1.02 Ratio |
| Arm 1, Group X (40 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | AUC | 0.98 Ratio |
| Arm 1, Group X (40 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | C (max) N=8,12,18,17,4 | 0.63 Ratio |
| Arm 1, Group X (60 mg) - MTD | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | C (max) N=8,12,18,17,4 | 0.74 Ratio |
| Arm 1, Group X (60 mg) - MTD | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | AUC | 1.17 Ratio |
| Arm 1, Group X (80 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | AUC | 1.12 Ratio |
| Arm 1, Group X (80 mg) | Geometric Mean Ratio (GMR) Comparing Treatment Days in Arm 1 | C (max) N=8,12,18,17,4 | 1.41 Ratio |
Secondary
Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15
Time frame: Day 15
Population: Pharmacokinetic set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 20.1 hour | Standard Deviation 7.06 |
| Arm 1, Group X (30 mg) | Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 19.7 hour | Standard Deviation 6.03 |
| Arm 1, Group X (40 mg) | Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 21.4 hour | Standard Deviation 8.87 |
| Arm 1, Group X (60 mg) - MTD | Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 17.9 hour | Standard Deviation 4.61 |
| Arm 1, Group X (80 mg) | Half Life of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 17.7 hour | Standard Deviation 8.9 |
Secondary
Half Life of Panobinostat After the First Dose in Arms 1 and 2
Time frame: Day 1
Population: Pharmacokinetic set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Half Life of Panobinostat After the First Dose in Arms 1 and 2 | 13.8 hour | Standard Deviation 6.65 |
| Arm 1, Group X (30 mg) | Half Life of Panobinostat After the First Dose in Arms 1 and 2 | 18.2 hour | Standard Deviation 5.47 |
| Arm 1, Group X (40 mg) | Half Life of Panobinostat After the First Dose in Arms 1 and 2 | 13.6 hour | Standard Deviation 3.26 |
| Arm 1, Group X (60 mg) - MTD | Half Life of Panobinostat After the First Dose in Arms 1 and 2 | 19.7 hour | Standard Deviation 11.68 |
| Arm 1, Group X (80 mg) | Half Life of Panobinostat After the First Dose in Arms 1 and 2 | 15.4 hour | Standard Deviation 4.14 |
| Arm 1, Group Y (20 mg) | Half Life of Panobinostat After the First Dose in Arms 1 and 2 | 14.6 hour | Standard Deviation 2.6 |
Secondary
Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\]))
Time frame: Post dose to pre-dose (up to 3.5 years)
Population: Full Analysis Set (with available samples for analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 56.6 Percent Change | Standard Deviation 97.26 |
| Arm 1, Group X (30 mg) | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 22.5 Percent Change | Standard Deviation 45 |
| Arm 1, Group X (40 mg) | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 63.2 Percent Change | Standard Deviation 87.21 |
| Arm 1, Group X (60 mg) - MTD | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 591.4 Percent Change | Standard Deviation 2438.34 |
| Arm 1, Group X (80 mg) | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 31 Percent Change | Standard Deviation 70.04 |
| Arm 1, Group Y (20 mg) | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 66.7 Percent Change | — |
| Arm 1, Group Y (30 mg) | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 150.0 Percent Change | Standard Deviation 125.59 |
| Arm 1, Group Y (40 mg) - MTD | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 196.3 Percent Change | Standard Deviation 193.25 |
| Arm 1, Group Y (60 mg) | Highest Percent Change in Fetal Hemoglobin From Baseline in Arm 1 (MWF Every Week) | 1998.5 Percent Change | Standard Deviation 4250.04 |
Secondary
Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week)
All blood samples were drawn immediately prior to each administration of LBH589 dose and at the end of treatment (≤ 7 days post last dose (preferably ≥ 4 days \[96 hours\]))
Time frame: Post dose to pre-dose (up to 3.5 years)
Population: Full Analysis Set (with available samples for analysis)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | 96.2 Percent Change | Standard Deviation 103.01 |
| Arm 1, Group X (30 mg) | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | 67.7 Percent Change | Standard Deviation 131.87 |
| Arm 1, Group X (40 mg) | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | 59.3 Percent Change | Standard Deviation 125.18 |
| Arm 1, Group X (60 mg) - MTD | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | 34.2 Percent Change | Standard Deviation 47.88 |
| Arm 1, Group X (80 mg) | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | 0.0 Percent Change | — |
| Arm 1, Group Y (20 mg) | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | 200.7 Percent Change | Standard Deviation 210.73 |
| Arm 1, Group Y (30 mg) | Highest Percent Change of Fetal Hemoglobin From Baseline in Arm 2 (MWF Every Other Week) | 376.0 Percent Change | Standard Deviation 540.27 |
Secondary
Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15
From day 15 by dose with schedule: MWF every week
Time frame: Day 15
Population: Pharmacokinetic set
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 33.6 ng/mL | Standard Deviation 16.33 |
| Arm 1, Group X (30 mg) | Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 38.4 ng/mL | Standard Deviation 23.58 |
| Arm 1, Group X (40 mg) | Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 41.6 ng/mL | Standard Deviation 36.54 |
| Arm 1, Group X (60 mg) - MTD | Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 51.8 ng/mL | Standard Deviation 28.78 |
| Arm 1, Group X (80 mg) | Maximum Plasma Concentration of Panobinostat After Multiple Doses in Arm 1 on Day 15 | 69.6 ng/mL | Standard Deviation 26.78 |
Secondary
Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2
Time frame: Day 1
Population: Pharmacokinetic set: Pharmacokinetic population consisted of all patients who provided at least one postdose PK plasma sample.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | 19.5 ng/mL | Standard Deviation 11.84 |
| Arm 1, Group X (30 mg) | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | 39.8 ng/mL | Standard Deviation 27.51 |
| Arm 1, Group X (40 mg) | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | 58 ng/mL | Standard Deviation 34.25 |
| Arm 1, Group X (60 mg) - MTD | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | 54 ng/mL | Standard Deviation 28.38 |
| Arm 1, Group X (80 mg) | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | 66.9 ng/mL | Standard Deviation 46.55 |
| Arm 1, Group Y (20 mg) | Maximum Plasma Concentration of Panobinostat After the First Dose in Arms 1 and 2 | 63.5 ng/mL | Standard Deviation 36.6 |
Secondary
Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y
Time frame: Days 5, 8, 10, 12, 15, End of study (up to 3.5 years)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 8 (total = 1, 4, 6) | 100.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | End of Study (Total=0, 2, 0) | NA Percentages of participants |
| Arm 1, Group X (20 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 5 (total=1, 4, 6) | 100.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 10 (total=1, 4, 5) | NA Percentages of participants |
| Arm 1, Group X (20 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 12 (Total=0, 3, 5) | NA Percentages of participants |
| Arm 1, Group X (20 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 15 (Total=1, 3, 5) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 12 (Total=0, 3, 5) | 33.3 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 15 (Total=1, 3, 5) | 33.3 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 8 (total = 1, 4, 6) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 10 (total=1, 4, 5) | 50.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | End of Study (Total=0, 2, 0) | 50.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 5 (total=1, 4, 6) | 100.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | End of Study (Total=0, 2, 0) | NA Percentages of participants |
| Arm 1, Group X (40 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 8 (total = 1, 4, 6) | 83.3 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 10 (total=1, 4, 5) | 60.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 12 (Total=0, 3, 5) | 40.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 15 (Total=1, 3, 5) | 0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentage of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group Y | Day 5 (total=1, 4, 6) | 100.0 Percentages of participants |
Secondary
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X
Reporting the number of patients with a reading at the timepoint in the dose group.
Time frame: Days 1, 5, 8, 10, 15
Population: Full Analysis Set N=number of participants analyzed. total n=number of patients with a reading at the timepoint in the dose group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 10 (total=0, 0, 0, 0, 0, 1) | NA Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 15 (total=3, 3, 4, 2, 2) | 66.7 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 5 (total = 6, 4, 8, 17, 8) | 100.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 1 (total=0, 1, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 8 (total = 5, 4, 8, 17, 7) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 10 (total=0, 0, 0, 0, 0, 1) | NA Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 8 (total = 5, 4, 8, 17, 7) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 1 (total=0, 1, 0, 0, 0) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 15 (total=3, 3, 4, 2, 2) | 33.3 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 5 (total = 6, 4, 8, 17, 8) | 75.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 8 (total = 5, 4, 8, 17, 7) | 75.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 1 (total=0, 1, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 5 (total = 6, 4, 8, 17, 8) | 87.5 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 10 (total=0, 0, 0, 0, 0, 1) | NA Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 15 (total=3, 3, 4, 2, 2) | 50.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 15 (total=3, 3, 4, 2, 2) | 50.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 1 (total=0, 1, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 10 (total=0, 0, 0, 0, 0, 1) | NA Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 8 (total = 5, 4, 8, 17, 7) | 82.4 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 5 (total = 6, 4, 8, 17, 8) | 82.4 Percentages of participants |
| Arm 1, Group X (80 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 8 (total = 5, 4, 8, 17, 7) | 57.1 Percentages of participants |
| Arm 1, Group X (80 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 10 (total=0, 0, 0, 0, 0, 1) | 100.0 Percentages of participants |
| Arm 1, Group X (80 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 1 (total=0, 1, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (80 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 15 (total=3, 3, 4, 2, 2) | 50.0 Percentages of participants |
| Arm 1, Group X (80 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group X | Day 5 (total = 6, 4, 8, 17, 8) | 37.5 Percentages of participants |
Secondary
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y
Time frame: Days 5, 8, end of study (up to 3.5 years)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 5 (total= 1, 2, 15, 4) | 100.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | End of Study (total=1, 0, 0, 0) | 0.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 8 (total = 1, 3, 11, 4) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 5 (total= 1, 2, 15, 4) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | End of Study (total=1, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 8 (total = 1, 3, 11, 4) | 100.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 8 (total = 1, 3, 11, 4) | 72.7 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 5 (total= 1, 2, 15, 4) | 66.7 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | End of Study (total=1, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 5 (total= 1, 2, 15, 4) | 75.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | End of Study (total=1, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 1 (MWF Every Week), Group Y | Day 8 (total = 1, 3, 11, 4) | 75.0 Percentages of participants |
Secondary
Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X
Time frame: Days 5, 8, 10, 12, 15, End of study, Unscheduled (up to 3.5 years)
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 5 (total=4, 9, 6, 8) | 50.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | End of Study (Total=1, 4, 2, 0) | 100.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 15 (Total=4, 6, 2, 5) | 75.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 8 (total = 4, 7, 5, 7) | 50.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Unscheduled (Total=2, 0, 0, 0) | 50.0 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 10 (Total=3, 8, 5, 7) | 33.3 Percentages of participants |
| Arm 1, Group X (20 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 12 (Total=4, 6, 4, 8) | 25.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | End of Study (Total=1, 4, 2, 0) | 75.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 12 (Total=4, 6, 4, 8) | NA Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 10 (Total=3, 8, 5, 7) | 37.5 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 15 (Total=4, 6, 2, 5) | 50.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Unscheduled (Total=2, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 8 (total = 4, 7, 5, 7) | 100.0 Percentages of participants |
| Arm 1, Group X (30 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 5 (total=4, 9, 6, 8) | 88.9 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 12 (Total=4, 6, 4, 8) | 50.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 5 (total=4, 9, 6, 8) | 83.3 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 8 (total = 4, 7, 5, 7) | 80.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 10 (Total=3, 8, 5, 7) | 80.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 15 (Total=4, 6, 2, 5) | 100.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | End of Study (Total=1, 4, 2, 0) | 50.0 Percentages of participants |
| Arm 1, Group X (40 mg) | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Unscheduled (Total=2, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 10 (Total=3, 8, 5, 7) | 100.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Unscheduled (Total=2, 0, 0, 0) | NA Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | End of Study (Total=1, 4, 2, 0) | 0.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 8 (total = 4, 7, 5, 7) | 100.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 5 (total=4, 9, 6, 8) | 100.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 15 (Total=4, 6, 2, 5) | 60.0 Percentages of participants |
| Arm 1, Group X (60 mg) - MTD | Percentages of Participants With Histone Acetylation Induction in Peripheral Blood in Arm 2 (MWF Every Other Week), Group X | Day 12 (Total=4, 6, 4, 8) | 50.0 Percentages of participants |
Secondary
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML)
Response as per investigator assessment for patients include complete response, progressive disease/failure, stable disease.
Time frame: 3.5 years
Population: Full Analysis Set: defined according to the Intention to Treat (ITT) principle. This population set included all patients to whom study treatment had been assigned.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Complete response (CR) | 2 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Partial remission (PR) | 1 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Stable disease (SD) | 25 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Progressive disease (PD)/failure | 17 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Not evaluable | 3 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Missing | 11 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Not evaluable | 1 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Complete response (CR) | 0 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Progressive disease (PD)/failure | 4 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Partial remission (PR) | 1 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Missing | 8 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) | Stable disease (SD) | 10 Participants |
Secondary
Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase
Stage 2 did not open for enrollment.
Time frame: 1.2 years
Population: Full Analysis Set. Response as per investigator assessment for a subset of patients with AML accrued in the expansion phase (IA) include complete response, progressive disease/failure, stable disease.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase | Complete response (CR) | 1 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase | Progressive disease (PD)/failure | 5 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase | Stable disease (SD) | 6 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase | Not evaluable | 2 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Acute Myelogenous Leukemia (AML) in Expansion Phase | Missing | 5 Participants |
Secondary
Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD)
Response as per investigator assessment for patients include complete response, partial remission, stable disease, progressive disease (PD)/failure.
Time frame: 3.5 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Partial remission (PR) | 4 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Progressive disease (PD)/failure | 1 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Stable disease (SD) | 11 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Missing | 5 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Complete response (CR) | 1 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Missing | 0 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Complete response (CR) | 1 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Partial remission (PR) | 3 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Stable disease (SD) | 4 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Hodgkin's Lymphoma (HD) | Progressive disease (PD)/failure | 2 Participants |
Secondary
Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS)
Response as per investigator assessment for patients include complete response, stable disease, progressive disease/failure, partial remission.
Time frame: 3.5 years
Population: Full Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Stable disease (SD) | 4 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Missing | 1 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Progressive disease (PD)/failure | 4 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Partial remission (PR) | 0 Participants |
| Arm 1, Group X (20 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Complete response (CR) | 0 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Partial remission (PR) | 1 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Complete response (CR) | 0 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Stable disease (SD) | 1 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Progressive disease (PD)/failure | 0 Participants |
| Arm 1, Group X (30 mg) | Response as Per Investigator Assessment for Patients With Myelodysplastic Syndromes (MDS) | Missing | 0 Participants |