Trial Outcomes & Findings for Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome (NCT NCT01892371)
NCT ID: NCT01892371
Last Updated: 2025-04-06
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
73 participants
Primary outcome timeframe
At 28 days
Results posted on
2025-04-06
Participant Flow
Participant milestones
| Measure |
Phase 1 Arm I (Quizartinib, Azacitidine)
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 1 Arm II (Quizartinib, Cytarabine)
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
Quizartinib: Given PO
|
Phase 2 Arm I (Quizartinib, Azacitidine)
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 2 Arm II (Quizartinib, Cytarabine)
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
1
|
35
|
32
|
|
Overall Study
COMPLETED
|
5
|
1
|
35
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome
Baseline characteristics by cohort
| Measure |
Phase 1 Arm I (Quizartinib, Azacitidine)
n=5 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 1 Arm II (Quizartinib, Cytarabine)
n=1 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
Quizartinib: Given PO
|
Phase 2 Arm I (Quizartinib, Azacitidine)
n=35 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 2 Arm II (Quizartinib, Cytarabine)
n=32 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=31 Participants
|
|
Age, Continuous
|
47 Years
n=99 Participants
|
58 Years
n=107 Participants
|
68 Years
n=206 Participants
|
71 Years
n=7 Participants
|
69 Years
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=99 Participants
|
1 participants
n=107 Participants
|
35 participants
n=206 Participants
|
32 participants
n=7 Participants
|
73 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: At 28 daysOutcome measures
| Measure |
Phase 1 Arm I (Quizartinib, Azacitidine)
n=5 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 1 Arm II (Quizartinib, Cytarabine)
n=1 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
Quizartinib: Given PO
|
Phase 2 Arm I (Quizartinib, Azacitidine)
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 2 Arm II (Quizartinib, Cytarabine)
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
|
|---|---|---|---|---|
|
Maximum Tolerated Dose of Quizartinib (Phase I)
|
60 Milligrams
|
60 Milligrams
|
—
|
—
|
PRIMARY outcome
Timeframe: At 56 days(complete remission \[CR\]+complete response with incomplete bone marrow recovery \[CRI\]+partial remission \[PR\]+ hematologic improvement \[HI\]). Complete Rmission (CR) is bone marrow blasts of \</= 5%, platelets \>/= 100 and Absolute Neutrophil Count of \>/= 1000. complete response with incomplete bone marrow recovery \[CRI\] is is bone marrow blasts of \</= 5%, platelets \>/= 100 or Absolute Neutrophil Count of \>/= 1000. Hematologic improvement \[HI\]) is Bone Marrow Blasts \</= 5%. Partial remission \[PR\] is bone marrow blasts of \</= 5% with \> 50% reduction, platelets \>/= 100 and Absolute Neutrophil Count of \>/= 1000.
Outcome measures
| Measure |
Phase 1 Arm I (Quizartinib, Azacitidine)
n=5 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 1 Arm II (Quizartinib, Cytarabine)
n=1 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
Quizartinib: Given PO
|
Phase 2 Arm I (Quizartinib, Azacitidine)
n=35 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 2 Arm II (Quizartinib, Cytarabine)
n=32 Participants
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
|
|---|---|---|---|---|
|
Participants With a Response
|
2 Participants
|
1 Participants
|
27 Participants
|
19 Participants
|
Adverse Events
Phase 1 Arm I (Quizartinib, Azacitidine)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 1 deaths
Phase 1 Arm II (Quizartinib, Cytarabine)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Phase 2 Arm I (Quizartinib, Azacitidine)
Serious events: 14 serious events
Other events: 32 other events
Deaths: 3 deaths
Phase 2 Arm II (Quizartinib, Cytarabine)
Serious events: 21 serious events
Other events: 32 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1 Arm I (Quizartinib, Azacitidine)
n=5 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 1 Arm II (Quizartinib, Cytarabine)
n=1 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
Quizartinib: Given PO
|
Phase 2 Arm I (Quizartinib, Azacitidine)
n=35 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 2 Arm II (Quizartinib, Cytarabine)
n=32 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 4 • Up to 9 years, 2 months
|
|
General disorders
Fever
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Gastric Hemorrhage
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Colon Graft Versus Host Disease
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Infections and infestations
Infection
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
17.1%
6/35 • Number of events 6 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Eye disorders
Loss of peripheral Eye Sight
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Infections and infestations
Lung infection
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
11.4%
4/35 • Number of events 6 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 11 • Up to 9 years, 2 months
|
|
General disorders
Pain
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Infections and infestations
Penumonia
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Rash pustular
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Rectal pain
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Nervous system disorders
Stroke
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Nervous system disorders
Transient ischemic attacks
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
General disorders
Death
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
General disorders
Failure to Thrive
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
Other adverse events
| Measure |
Phase 1 Arm I (Quizartinib, Azacitidine)
n=5 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 1 Arm II (Quizartinib, Cytarabine)
n=1 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
Quizartinib: Given PO
|
Phase 2 Arm I (Quizartinib, Azacitidine)
n=35 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and azacitidine SC or IV over 10-40 minutes on days 1-7. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Azacitidine: Given SC or IV
Quizartinib: Given PO
|
Phase 2 Arm II (Quizartinib, Cytarabine)
n=32 participants at risk
Patients receive quizartinib PO QD on days 5-28 of cycle 1 and on days 1-28 of subsequent cycles and cytarabine SC BID on days 1-10. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cytarabine: Given SC
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Black Hairy Tongue
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Psychiatric disorders
Agitation
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Investigations
Alanine aminotransferase increased
|
80.0%
4/5 • Number of events 4 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
57.1%
20/35 • Number of events 20 • Up to 9 years, 2 months
|
34.4%
11/32 • Number of events 11 • Up to 9 years, 2 months
|
|
Investigations
Alkaline phosphatase increased
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Rhinitis
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/5 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 4 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Anorexia
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
11.4%
4/35 • Number of events 4 • Up to 9 years, 2 months
|
18.8%
6/32 • Number of events 6 • Up to 9 years, 2 months
|
|
Psychiatric disorders
Anxiety
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
14.3%
5/35 • Number of events 7 • Up to 9 years, 2 months
|
21.9%
7/32 • Number of events 7 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Investigations
Blood bilirubin increased
|
80.0%
4/5 • Number of events 4 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
57.1%
20/35 • Number of events 20 • Up to 9 years, 2 months
|
21.9%
7/32 • Number of events 7 • Up to 9 years, 2 months
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
General disorders
Chills
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 4 • Up to 9 years, 2 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
11.4%
4/35 • Number of events 4 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/5 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
11.4%
4/35 • Number of events 4 • Up to 9 years, 2 months
|
18.8%
6/32 • Number of events 6 • Up to 9 years, 2 months
|
|
Investigations
Creatinine decreased
|
20.0%
1/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
62.9%
22/35 • Number of events 23 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
General disorders
Deconditioning
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Diarrhea
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
17.1%
6/35 • Number of events 6 • Up to 9 years, 2 months
|
40.6%
13/32 • Number of events 13 • Up to 9 years, 2 months
|
|
Nervous system disorders
Dizziness
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
8.6%
3/35 • Number of events 3 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Eye disorders
Dry eye
|
60.0%
3/5 • Number of events 3 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
18.8%
6/32 • Number of events 6 • Up to 9 years, 2 months
|
|
General disorders
Edema
|
60.0%
3/5 • Number of events 3 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
18.8%
6/32 • Number of events 8 • Up to 9 years, 2 months
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
11.4%
4/35 • Number of events 4 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 4 • Up to 9 years, 2 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
18.8%
6/32 • Number of events 6 • Up to 9 years, 2 months
|
|
General disorders
Fatigue
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
22.9%
8/35 • Number of events 8 • Up to 9 years, 2 months
|
25.0%
8/32 • Number of events 8 • Up to 9 years, 2 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
60.0%
3/5 • Number of events 3 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 2 • Up to 9 years, 2 months
|
40.0%
14/35 • Number of events 18 • Up to 9 years, 2 months
|
25.0%
8/32 • Number of events 9 • Up to 9 years, 2 months
|
|
General disorders
Fever
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 3 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
General disorders
Flu like symptoms
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
General disorders
fluid overload
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
General disorders
Gait disturbance
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
11.4%
4/35 • Number of events 4 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 4 • Up to 9 years, 2 months
|
|
General disorders
Gum bleeding
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Nervous system disorders
Headache
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Vascular disorders
Hematoma
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
General disorders
Hemorrhage
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
8.6%
3/35 • Number of events 3 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
20.0%
7/35 • Number of events 9 • Up to 9 years, 2 months
|
18.8%
6/32 • Number of events 6 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
8.6%
3/35 • Number of events 3 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
11.4%
4/35 • Number of events 4 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
20.0%
7/35 • Number of events 7 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
14.3%
5/35 • Number of events 5 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
17.1%
6/35 • Number of events 6 • Up to 9 years, 2 months
|
21.9%
7/32 • Number of events 7 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
80.0%
4/5 • Number of events 5 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
57.1%
20/35 • Number of events 20 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 9 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
80.0%
4/5 • Number of events 4 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
62.9%
22/35 • Number of events 22 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 9 • Up to 9 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Hypomagnesemia
|
80.0%
4/5 • Number of events 4 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
65.7%
23/35 • Number of events 23 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 9 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
60.0%
3/5 • Number of events 3 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
42.9%
15/35 • Number of events 15 • Up to 9 years, 2 months
|
25.0%
8/32 • Number of events 8 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
31.4%
11/35 • Number of events 11 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
8.6%
3/35 • Number of events 3 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 9 • Up to 9 years, 2 months
|
|
Infections and infestations
Infection
|
40.0%
2/5 • Number of events 3 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
31.4%
11/35 • Number of events 13 • Up to 9 years, 2 months
|
25.0%
8/32 • Number of events 9 • Up to 9 years, 2 months
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Infections and infestations
Lung infection
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
17.1%
6/35 • Number of events 6 • Up to 9 years, 2 months
|
37.5%
12/32 • Number of events 15 • Up to 9 years, 2 months
|
|
General disorders
Malaise
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
mouth sores
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Mucositis oral
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
12.5%
4/32 • Number of events 4 • Up to 9 years, 2 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Nausea
|
60.0%
3/5 • Number of events 3 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
22.9%
8/35 • Number of events 9 • Up to 9 years, 2 months
|
43.8%
14/32 • Number of events 14 • Up to 9 years, 2 months
|
|
Investigations
Neutrophil count decreased
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 9 • Up to 9 years, 2 months
|
|
General disorders
Pain
|
60.0%
3/5 • Number of events 7 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
20.0%
7/35 • Number of events 12 • Up to 9 years, 2 months
|
50.0%
16/32 • Number of events 35 • Up to 9 years, 2 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Metabolism and nutrition disorders
Phosphorus increased
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/32 • Up to 9 years, 2 months
|
|
Investigations
Platelet count decreased
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
8.6%
3/35 • Number of events 3 • Up to 9 years, 2 months
|
25.0%
8/32 • Number of events 8 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/5 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Infections and infestations
Pneumonitis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 9 • Up to 9 years, 2 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
8.6%
3/35 • Number of events 3 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
3.1%
1/32 • Number of events 1 • Up to 9 years, 2 months
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
|
General disorders
Ulcer
|
20.0%
1/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 4 • Up to 9 years, 2 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
0.00%
0/35 • Up to 9 years, 2 months
|
9.4%
3/32 • Number of events 3 • Up to 9 years, 2 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
15.6%
5/32 • Number of events 5 • Up to 9 years, 2 months
|
|
Gastrointestinal disorders
Vomiting
|
40.0%
2/5 • Number of events 2 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
14.3%
5/35 • Number of events 5 • Up to 9 years, 2 months
|
28.1%
9/32 • Number of events 9 • Up to 9 years, 2 months
|
|
Investigations
White blood cell decreased
|
20.0%
1/5 • Number of events 1 • Up to 9 years, 2 months
|
100.0%
1/1 • Number of events 1 • Up to 9 years, 2 months
|
5.7%
2/35 • Number of events 2 • Up to 9 years, 2 months
|
40.6%
13/32 • Number of events 13 • Up to 9 years, 2 months
|
|
Injury, poisoning and procedural complications
wound
|
0.00%
0/5 • Up to 9 years, 2 months
|
0.00%
0/1 • Up to 9 years, 2 months
|
2.9%
1/35 • Number of events 1 • Up to 9 years, 2 months
|
6.2%
2/32 • Number of events 2 • Up to 9 years, 2 months
|
Additional Information
Yesid Alvarado MD./Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-794-4364
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place