TriangleNCT01892371 · OUTCOME
Participants With a Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- At 56 days
What was measured
(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.
Groups in this outcome
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
| Group | Source count |
|---|---|
| Phase 1 Arm I (Quizartinib, Azacitidine) | 5 |
| Phase 1 Arm II (Quizartinib, Cytarabine) | 1 |
| Phase 2 Arm I (Quizartinib, Azacitidine) | 35 |
| Phase 2 Arm II (Quizartinib, Cytarabine) | 32 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Arm I (Quizartinib, Azacitidine) | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Arm II (Quizartinib, Cytarabine) | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Arm I (Quizartinib, Azacitidine) | 27 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 Arm II (Quizartinib, Cytarabine) | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 27
- group Id
- OG003
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 32
- units
- Participants
- description
- (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.
- groups
- description
- 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
- id
- OG000
- title
- Phase 1 Arm I (Quizartinib, Azacitidine)
- description
- 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
- id
- OG001
- title
- Phase 1 Arm II (Quizartinib, Cytarabine)
- description
- 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
- id
- OG002
- title
- Phase 2 Arm I (Quizartinib, Azacitidine)
- description
- 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
- id
- OG003
- title
- Phase 2 Arm II (Quizartinib, Cytarabine)
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- At 56 days
- title
- Participants With a Response
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice