Trial Outcomes & Findings for A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes (NCT NCT03151304)
NCT ID: NCT03151304
Last Updated: 2022-03-02
Results Overview
Percentage of subjects with confirmed complete remission (CR), partial remission (PR) and marrow CR, as per modified International Working Group (IWG) criteria: CR: Bone marrow: ≤5% myeloblasts with normal maturation of all cell lines; Peripheral blood Hemoglobin (Hb) ≥11 g/dL; Platelets ≥100 × 10\^9/L; Neutrophils ≥1.0 × 10\^9/L; Blasts 0%. PR: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pre-treatment but still \>5%; Cellularity and morphology not relevant Marrow CR: Bone marrow: ≤5% myeloblasts and decrease by ≥50% over pre-treatment
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
36 months
Results posted on
2022-03-02
Participant Flow
Stage 1 was to be conducted in 20-40 evaluable subjects to assess if the pracinostat dose regimen resulted in a discontinuation rate that met a predefined threshold, and the observed efficacy justified expansion of enrollment in Stage 1b. Stage 1b was conducted to achieve a planned total enrollment of 60 subjects evaluable for efficacy, inclusive of Stage 1 and Stage 1b enrollment.
Participant milestones
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Overall Study
STARTED
|
64
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
64
|
Reasons for withdrawal
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Overall Study
Termination of study by Sponsor
|
23
|
|
Overall Study
missing
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
|
Overall Study
multiple reasons
|
30
|
Baseline Characteristics
A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes
Baseline characteristics by cohort
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 8.59 • n=5 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
64 participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
30.53 Kg/m^2
STANDARD_DEVIATION 5.88 • n=5 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPercentage of subjects with confirmed complete remission (CR), partial remission (PR) and marrow CR, as per modified International Working Group (IWG) criteria: CR: Bone marrow: ≤5% myeloblasts with normal maturation of all cell lines; Peripheral blood Hemoglobin (Hb) ≥11 g/dL; Platelets ≥100 × 10\^9/L; Neutrophils ≥1.0 × 10\^9/L; Blasts 0%. PR: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pre-treatment but still \>5%; Cellularity and morphology not relevant Marrow CR: Bone marrow: ≤5% myeloblasts and decrease by ≥50% over pre-treatment
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Overall Response Rate (ORR)
|
35.9 percentage of subjects
Interval 24.3 to 48.9
|
SECONDARY outcome
Timeframe: 36 monthsPercentage of subjects with confirmed CR (i.e., 2 CRs at least 28 days apart) as per modified IWG criteria: CR: Bone marrow: ≤5% myeloblasts with normal maturation of all cell lines; Peripheral blood Hb ≥11 g/dL; Platelets ≥100 × 109/L; Neutrophils ≥1.0 × 109/L; Blasts 0%.
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Complete Response (CR) Rate
|
35.9 percentage of subjects with CR
Interval 24.3 to 48.9
|
SECONDARY outcome
Timeframe: 36 monthsPercentage of subjects demonstrating major hematologic improvement according to modified IWG: Erythroid response (pre-treatment, \<11 g/dL): Hb increase by ≥1.5 g/dL; Relevant reduction of units of RBC transfusions by an absolute number of at least 4 RBC transfusions/8 weeks compared with the pre-treatment transfusion number in the previous 8 weeks. Only RBC transfusions given for a Hb of ≤9.0 g/dL pre-treatment will count in the RBC transfusion response evaluation. Platelet response (pre-treatment, \<100 × 10\^9/L): Absolute increase of ≥30 × 10\^9/L for patients starting with \>20 × 10\^9/L platelets; Increase from \<20 × 10\^9/L to \>20 × 10\^9/L and by at least 100%. Neutrophil response (pre-treatment, \<1.0 × 10\^9/L): At least 100% increase and an absolute increase \>0.5 × 10\^9/L. Progression or relapse after HI: at least 1 of the following: * At least 50% decrement from maximum response levels in granulocytes or platelets * Reduction in Hb by≥1.5 g/dL * Transfusion dependence
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=63 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Overall Hematologic Improvement (HI) Response Rate
|
71.4 percentage of subjects with HI
Interval 58.7 to 82.1
|
SECONDARY outcome
Timeframe: 36 monthsPercentage of subjects with confirmed CR, PR, Marrow CR, and HI with clinical benefit rate, defines as rate of CR + PR + HI + Marrow CR. All subjects who achieve hematologic CR, PR, marrow CR, or hematologic improvement on the erythrocytic lineage per modified IWG response criteria will be considered responders
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Clinical Benefit Rate
|
78.1 percentage of subjects with benefit rate
Interval 66.0 to 87.5
|
SECONDARY outcome
Timeframe: 36 monthsPercentage of subjects with confirmed CR by cytogenetic assessment. Complete cytogenetic response is defined per modified IWG response criteria: Complete: Disappearance of the chromosomal abnormality without appearance of new ones Partial: At least 50% reduction of the chromosomal abnormality
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Rate of Cytogenetic CR
|
46.9 percentage of subjects with cCR
Interval 34.3 to 59.8
|
SECONDARY outcome
Timeframe: 36 monthsFor subjects who have achieved CR, PR, Marrow CR, or HI, DoR is defined as the time from the initial determination of response to the time of disease progression or death on study, whichever occurs first.
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=59 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Duration of Response (DoR)
|
15.67 months
Interval 9.0 to 22.11
|
SECONDARY outcome
Timeframe: 6 monthsPercentage of subjects with leukemic transformation at landmark time point of 6 months
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=59 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Rate of Leukemic Transformation
|
5.4 percentage of subjects
Interval 1.8 to 15.8
|
SECONDARY outcome
Timeframe: 36 monthstime from the first day of study drug administration (Day 1) to failure or death from any cause
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=59 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Event-free Survival (EFS)
|
17.05 months
Interval 11.5 to 21.95
|
SECONDARY outcome
Timeframe: 36 monthstime from the first day of study drug administration (Day 1) to disease recurrence or progression as defined by the IWG criteria, or death on study: Disease progression for subjects with: Less than 5% blasts: ≥50% increase in blasts to \>5% blasts 5%-10% blasts: ≥50% increase to \>10% blasts 10%-20% blasts: ≥50% increase to \>20% blasts 20%-30% blasts: ≥50% increase to \>30% blasts Any of the following: At least 50% decrement from maximum remission/response in granulocytes or platelets Reduction in Hb by ≥2 g/dL Transfusion dependence
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Progression-free Survival (PFS)
|
16.43 months
Interval 11.33 to 22.57
|
SECONDARY outcome
Timeframe: form day 1 to death on study, assessed up to 36 monthstime from the first day of study drug administration (Day 1) to death on study
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Overall Survival (OS)
|
23.56 months
Interval 16.49 to 30.26
|
SECONDARY outcome
Timeframe: 12 monthsPercentage of subjects with leukemic transformation at landmark time point of 12 months
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=59 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Rate of Leukemic Transformation
|
9.5 percentage of subjects
Interval 3.3 to 25.4
|
SECONDARY outcome
Timeframe: 18 monthsPercentage of subjects with leukemic transformation at landmark time point of 18 months
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=59 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Rate of Leukemic Transformation
|
13.8 percentage of subjects
Interval 5.5 to 32.4
|
SECONDARY outcome
Timeframe: 24 monthsPercentage of subjects with leukemic transformation at landmark time point of 24 months
Outcome measures
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=59 Participants
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Rate of Leukemic Transformation
|
21.6 percentage of subjects
Interval 8.8 to 47.3
|
Adverse Events
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
Serious events: 45 serious events
Other events: 64 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 participants at risk
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
26.6%
17/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Acute coronary syndrome
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Atrial fibrillation
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Cardiac failure
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Pericardial effusion
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Pericarditis
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Sinus tachycardia
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Anal fissure
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Ascites
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Dysphagia
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Proctitis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Rectal ulcer
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Stomatitis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Vomiting
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Asthenia
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Malaise
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Pyrexia
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Abscess limb
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Anal abscess
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Cellulitis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Clostridial sepsis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Clostridium difficile colitis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Escherichia sepsis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Fungal oesophagitis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Influenza
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Lung infection
|
4.7%
3/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Perirectal abscess
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Pneumonia
|
9.4%
6/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Pseudomonal sepsis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Respiratory tract infection viral
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Sepsis
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Sialoadenitis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Staphylococcal infection
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Staphylococcal sepsis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Streptococcal sepsis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Vascular access site infection
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Injury, poisoning and procedural complications
Fall
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
Electrocardiogram qt prolonged
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
Neutrophil count decreased
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hyperinsulinaemic hypoglycaemia
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Presyncope
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Syncope
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Psychiatric disorders
Mania
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Psychiatric disorders
Mental disorder
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Renal and urinary disorders
Haematuria
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Renal and urinary disorders
Renal failure
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.1%
2/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Vascular disorders
Deep vein thrombosis
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Vascular disorders
Orthostatic hypotension
|
1.6%
1/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
Other adverse events
| Measure |
Stage 1a and 1b Open-label Pracinostat Plus Azacitidine
n=64 participants at risk
open-label single arm pracinostat plus azacitidine. Pracinostat: 45 mg administered orally 3 days each week for 3 consecutive weeks, followed by 1 week of rest, in 28-day cycles.
In later cycles (i.e., after Cycle 4), pracinostat dose reduction to 45 mg orally 3 days each week × 2 weeks (instead of 3 weeks) or dose interruption is allowed to manage toxicity such as fatigue, gastrointestinal toxicity, or myelosuppression.
Azacitidine: 75 mg/m2 for 7 days of each 28-day cycle. Administration will occur by subcutaneous (SC) injection, or IV infusion if SC injections are not tolerated, on one of two schedules:
* Schedule 1 - daily therapy on Days 1 through 7
* Schedule 2 - 5-2-2 schedule in which subjects receive azacitidine for 5 consecutive days (Days 1 through 5) with rest on Days 6 and 7, and resume azacitidine dosing the first two days of the next week (Days 8 and 9) of each 28-day cycle
Pracinostat: 45 mg capsule
Azacitidine: SC or IV injection
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
48.4%
31/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
35.9%
23/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.1%
9/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.1%
18/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Cardiac disorders
Tachycardia
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Eye disorders
Dry eye
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Constipation
|
51.6%
33/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.8%
21/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Dry mouth
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.4%
6/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Dysphagia
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Nausea
|
53.1%
34/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Oral pain
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Proctalgia
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Tongue discolouration
|
21.9%
14/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
16/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Asthenia
|
9.4%
6/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Chest pain
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Chills
|
14.1%
9/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Fatigue
|
45.3%
29/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Injection site reaction
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Oedema peripheral
|
35.9%
23/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
General disorders
Pyrexia
|
18.8%
12/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Lung infection
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Pneumonia
|
12.5%
8/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Sepsis
|
9.4%
6/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Sinusitis
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Infections and infestations
Urinary tract infection
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Injury, poisoning and procedural complications
Contusion
|
15.6%
10/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Injury, poisoning and procedural complications
Fall
|
15.6%
10/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
Blood creatinine increased
|
12.5%
8/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
International normalised ratio increased
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
Lymphocyte count decreased
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
Neutrophil count decreased
|
53.1%
34/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
Weight decreased
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Investigations
White blood cell count decreased
|
21.9%
14/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
40.6%
26/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Dehydration
|
15.6%
10/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.5%
8/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.1%
18/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.1%
9/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
16/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
20.3%
13/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.3%
13/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
8/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.4%
6/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.1%
9/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Dizziness
|
29.7%
19/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Dysgeusia
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Headache
|
12.5%
8/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Presyncope
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Syncope
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Nervous system disorders
Tremor
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Psychiatric disorders
Anxiety
|
15.6%
10/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Psychiatric disorders
Confusional state
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Psychiatric disorders
Insomnia
|
18.8%
12/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Renal and urinary disorders
Acute kidney injury
|
14.1%
9/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Renal and urinary disorders
Pollakiuria
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Renal and urinary disorders
Urinary retention
|
9.4%
6/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.4%
15/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.2%
20/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.1%
9/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
8/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.9%
7/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
4/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.6%
10/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Skin and subcutaneous tissue disorders
Papule
|
7.8%
5/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
6/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Skin and subcutaneous tissue disorders
Rash
|
17.2%
11/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
15.6%
10/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Vascular disorders
Hypertension
|
12.5%
8/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
|
Vascular disorders
Hypotension
|
23.4%
15/64 • All AEs regardless of seriousness or relationship to pracinostat or azacitidine, from the start of study drug treatment until 30 calendar days after discontinuation or completion of treatment as defined by the clinical study for that subject, have been recorded.
|
Additional Information
Francesco Scarci, Clinical Operations Manager
Helsinn Healthcare
Phone: +41 (0)91 985 2121
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place