Trial Outcomes & Findings for Pacritinib Combined With Decitabine or Cytarabine in Older Patients With AML (NCT NCT02532010)
NCT ID: NCT02532010
Last Updated: 2018-06-15
Results Overview
Complete remission rate is defined as number of subjects with complete remission according to the IWG criteria, which is defined by presence of \<5 percent of blasts in the bone marrow, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
6 months
Results posted on
2018-06-15
Participant Flow
Participant milestones
| Measure |
Arm A: Pacritinib and Decitiabine
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
4
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pacritinib Combined With Decitabine or Cytarabine in Older Patients With AML
Baseline characteristics by cohort
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Age, Continuous
|
76 years
n=39 Participants
|
73 years
n=41 Participants
|
75 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
10 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
9 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 6 monthsComplete remission rate is defined as number of subjects with complete remission according to the IWG criteria, which is defined by presence of \<5 percent of blasts in the bone marrow, absence of blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count \>1.0 x 109/L (1000/µL); platelet count \>100 x 109/L (100,000/µL); independence of red cell transfusions.
Outcome measures
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Complete Remission Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsSurvival following treatment to the date of death
Outcome measures
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Overall Survival
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 monthsOverall remission rate is defined as number of subjects with complete remission (CR), Complete Remission with incomplete platelet recovery (CRp), Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR) according to the IWG criteria. CRi is defined as All CR criteria except for residual neutropenia (\<1.0 x 109/L (1000/µL)) or thrombocytopenia (\<100 x 109/L (100,000/µL)), PR is defined as relevant in the setting of phase I and II clinical trials only; all hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25 percent; and decrease of pretreatment bone marrow blast percentage by at least 50 percent.
Outcome measures
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Overall Remission Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From date of complete remission until either AML relapse or death from any cause, whichever came first, assessed throughout the study period up to 2 yearsTime from complete remission documentation to either AML relapse or death from any cause.
Outcome measures
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Relapse-free Survival
|
NA months
No patients achieved complete remission
|
NA months
No patients achieved complete remission
|
SECONDARY outcome
Timeframe: Time from entry on study until time at which there is treatment failure, AML relapse, or death from any cause, assessed throughout the study period up to 2 yearsTime from entry on study until time at which there is treatment failure, AML relapse, or death from any cause
Outcome measures
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Event-free Survival
|
2.5 months
Interval 2.0 to 4.0
|
3 months
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: From entry on study until complete remission, assessed throughout the study period up to 2 yearsTime from entry on study until documentation of complete remission (CR)
Outcome measures
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Time to Complete Response
|
NA months
No patients achieved complete remission
|
NA months
No patients achieved complete remission
|
SECONDARY outcome
Timeframe: time from complete remission to AML relapse, assessed throughout the study period up to 2 years.Time from CR documentation to AML relapse
Outcome measures
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 Participants
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 Participants
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Remission Duration
|
NA months
No patients achieved complete remission
|
NA months
No patients achieved complete remission
|
Adverse Events
Arm A: Pacritinib and Decitiabine
Serious events: 9 serious events
Other events: 9 other events
Deaths: 9 deaths
Arm B: Pacritinib and Cytarabine
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 participants at risk
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 participants at risk
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Nervous system disorders
Dizziness and right shoulder pain
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
General disorders
fever
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
presyncope
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
neutropenic fever
|
22.2%
2/9 • Number of events 3 • 2 years, 4 months
|
50.0%
2/4 • Number of events 4 • 2 years, 4 months
|
|
General disorders
failure to thrive
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Psychiatric disorders
anxiety
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
congestive heart failure
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
cardiopulmonary arrest
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Nervous system disorders
dizziness
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
dehydration/diarrhea
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
chest pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
fall
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Renal and urinary disorders
hematuria
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
oral ulceration
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
Other adverse events
| Measure |
Arm A: Pacritinib and Decitiabine
n=9 participants at risk
Arm A: Each cycle: Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Decitabine: Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
|
Arm B: Pacritinib and Cytarabine
n=4 participants at risk
Arm B: Each cycle: Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
Pacritinib: Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nM and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit JAK1.
Cytarabine: Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
|
|---|---|---|
|
Nervous system disorders
nausea
|
77.8%
7/9 • Number of events 7 • 2 years, 4 months
|
100.0%
4/4 • Number of events 6 • 2 years, 4 months
|
|
General disorders
anorexia
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
50.0%
2/4 • Number of events 4 • 2 years, 4 months
|
|
Nervous system disorders
dizziness
|
44.4%
4/9 • Number of events 4 • 2 years, 4 months
|
75.0%
3/4 • Number of events 4 • 2 years, 4 months
|
|
Gastrointestinal disorders
vomiting
|
44.4%
4/9 • Number of events 4 • 2 years, 4 months
|
50.0%
2/4 • Number of events 5 • 2 years, 4 months
|
|
General disorders
fatigue
|
88.9%
8/9 • Number of events 8 • 2 years, 4 months
|
50.0%
2/4 • Number of events 3 • 2 years, 4 months
|
|
Psychiatric disorders
insomnia
|
66.7%
6/9 • Number of events 6 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
constipation
|
77.8%
7/9 • Number of events 7 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
General disorders
bleeding gums
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
General disorders
dry mouth
|
44.4%
4/9 • Number of events 4 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
General disorders
fall
|
66.7%
6/9 • Number of events 6 • 2 years, 4 months
|
100.0%
4/4 • Number of events 4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
ecchymosis on buttocks
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Vascular disorders
orthostatic hypotension
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Infections and infestations
bacteremia
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Renal and urinary disorders
non-obstructing renal calculi/hematuria
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
mucositis
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
75.0%
3/4 • Number of events 3 • 2 years, 4 months
|
|
Cardiac disorders
chest pain
|
44.4%
4/9 • Number of events 4 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Vascular disorders
hypertension
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
25.0%
1/4 • Number of events 2 • 2 years, 4 months
|
|
Renal and urinary disorders
acute kidney injury
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Investigations
creatinine increased
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
presyncope
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Investigations
Ejection fraction decreased
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
75.0%
3/4 • Number of events 4 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
44.4%
4/9 • Number of events 8 • 2 years, 4 months
|
75.0%
3/4 • Number of events 4 • 2 years, 4 months
|
|
General disorders
Chills
|
44.4%
4/9 • Number of events 4 • 2 years, 4 months
|
75.0%
3/4 • Number of events 3 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
General disorders
Fever
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
55.6%
5/9 • Number of events 5 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
75.0%
3/4 • Number of events 3 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
hypovolemia
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
alkaline phosphatase increased
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
abdominal pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Hepatobiliary disorders
gallstones
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
bilateral leg cramps
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Nervous system disorders
anxiety
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
LE edema
|
55.6%
5/9 • Number of events 5 • 2 years, 4 months
|
75.0%
3/4 • Number of events 3 • 2 years, 4 months
|
|
Blood and lymphatic system disorders
coagulpathy
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Vascular disorders
Phlebitis
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
loss of appetite
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
maculo-papular rash
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
hallucinations
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
oral sore
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
pruitis
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
hemorraghic bullae
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Renal and urinary disorders
nocturia
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
postnasal drip
|
44.4%
4/9 • Number of events 5 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
drug rash
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Renal and urinary disorders
hematuria
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
oral fungal infection
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Renal and urinary disorders
urinary retention
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
back pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Renal and urinary disorders
external hemorrhoids
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
tachycardia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
rigors
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
Asteatotic eczema and xerosis lower legs and elbows
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary nodule
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
trochanteric bursitis
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea on exertion
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Infections and infestations
pruitic groin
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
non-specific body pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Infections and infestations
pyuria
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
sinus tachycardia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
rash on trunk/legs
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Renal and urinary disorders
increased urinary frequency
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Infections and infestations
oral thrush
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
great toe pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
tachypnea
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Infections and infestations
dysuria
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
congestive heart failure
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
NSVT
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Renal and urinary disorders
urinary distention
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
sacral pressure ulcer
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
dysphagia
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
dry skin
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
temporal wasting
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Eye disorders
right eye conjunctivitis
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
44.4%
4/9 • Number of events 4 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Vascular disorders
hypotension
|
55.6%
5/9 • Number of events 5 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Investigations
hypernatremia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Psychiatric disorders
confusion
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
respiratory failure
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
sinus bradycardia
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
cardiopulmonary arrest
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
hemorrhoidal hemorrhage
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
bradycardia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
generalized weakness
|
22.2%
2/9 • Number of events 3 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
nare lesion
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
internal hemorrhoids
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Metabolism and nutrition disorders
dehydration
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Infections and infestations
mucocutaneous pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Psychiatric disorders
depression
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
R shoulder pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Infections and infestations
genital herpes simplex
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
loose stool
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Infections and infestations
sepsis
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Psychiatric disorders
delirium
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
right chest pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
left chest pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
troponin I increased
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
VRE bacteremia
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
pitting edema
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
intertrigo
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
toenail discoloration
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Nervous system disorders
tremors
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
bruising
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
stomach burning
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
oral herpes sore
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
productive cough
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
dry nasal passages
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Eye disorders
L eye ecchymoses
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
intermittent swelling in feet
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Renal and urinary disorders
polyuria
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
petechiae on extremities
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
50.0%
2/4 • Number of events 2 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
lower back pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
b/l LE weakness
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
b/l feet purpura
|
0.00%
0/9 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
blanching erythmatous rash on arm and back
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Eye disorders
eye floaters
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Vascular disorders
R wrist hematoma
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Investigations
hypophosphatemia
|
33.3%
3/9 • Number of events 3 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
hemoptysis
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusions
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hemorrhage
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
septic shock
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Investigations
elevated lactate
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Gastrointestinal disorders
abdominal distension
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
decreased appetite
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
C. diff colitis
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Infections and infestations
polymicrobial sepsis
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
gas pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Psychiatric disorders
altered mental status
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Renal and urinary disorders
oliguyric AKI
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
hypoalbuminemia
|
22.2%
2/9 • Number of events 3 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
stomach ache
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
rectal bleeding
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
rash on arms/legs
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
oral ulceration
|
11.1%
1/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
sore on tongue
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Nervous system disorders
numbness in feet
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
avulsed toenail
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
dry right sole of foot
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Gastrointestinal disorders
R sided dental pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
hypocalcemia
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
General disorders
edema
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
headache
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
General disorders
fatigue upon exertion
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Respiratory, thoracic and mediastinal disorders
atypical pneumonia
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
General disorders
sweats
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Infections and infestations
lung infection
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
diffuse rash on trunk
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
erythematous lesion on L forearm
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Nervous system disorders
lightheadedness
|
11.1%
1/9 • Number of events 3 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
General disorders
hives following platelet transfusion
|
0.00%
0/9 • 2 years, 4 months
|
25.0%
1/4 • Number of events 1 • 2 years, 4 months
|
|
Investigations
hyperglycemia
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Investigations
increased LDH
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Renal and urinary disorders
forceful urination
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
prolonged QTc interval
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
malaise
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Cardiac disorders
intermittent chest palpitations
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
General disorders
night sweats
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
R hip pain
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Nervous system disorders
numbness in fingers
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Musculoskeletal and connective tissue disorders
body aches
|
22.2%
2/9 • Number of events 2 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
b/l rash on groin
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
|
Skin and subcutaneous tissue disorders
RLQ papular rash
|
11.1%
1/9 • Number of events 1 • 2 years, 4 months
|
0.00%
0/4 • 2 years, 4 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place