NCT00261846 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML) Part 2 of the study.
- id
- FG000
- title
- Bosutinib 400 mg (Part 1)
- description
- Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
- id
- FG001
- title
- Bosutinib 500 mg (Part 1)
- description
- Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase (AP) CML Part 2 of the study.
- id
- FG002
- title
- Bosutinib 600 mg (Part 1)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
- id
- FG003
- title
- Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
- id
- FG004
- title
- Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
- id
- FG005
- title
- Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
- id
- FG006
- title
- Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
- id
- FG007
- title
- Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
- id
- FG008
- title
- Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
- description
- All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
- id
- FG009
- title
- AP-CML Total (Part 2)
- description
- All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
- id
- FG010
- title
- BP-CML Total (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
- id
- FG011
- title
- Bosutinib 500 mg, Ph+ ALL (Part 2)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Continued in to Part 2
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Period 1: Part 1 (Dose Escalation)
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Discontinuation of study by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 8
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 2
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 12
- group Id
- FG004
- num Subjects
- 4
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 4
- group Id
- FG010
- num Subjects
- 4
- group Id
- FG011
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 15
- group Id
- FG004
- num Subjects
- 4
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 5
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 4
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Other
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 37
- group Id
- FG004
- num Subjects
- 7
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 10
- group Id
- FG007
- num Subjects
- 12
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 30
- group Id
- FG010
- num Subjects
- 44
- group Id
- FG011
- num Subjects
- 22
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 61
- group Id
- FG004
- num Subjects
- 27
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 9
- group Id
- FG008
- num Subjects
- 5
- group Id
- FG009
- num Subjects
- 9
- group Id
- FG010
- num Subjects
- 1
- group Id
- FG011
- num Subjects
- 1
- type
- Extension study
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- comment
- 17 participants from Part 1 (Bosutinib 400mg, 500mg, 600mg cohort) continued in Part 2 of the study.
- group Id
- FG003
- num Subjects
- 195
- group Id
- FG004
- num Subjects
- 89
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 38
- group Id
- FG007
- num Subjects
- 50
- group Id
- FG008
- num Subjects
- 26
- comment
- 1 participant from Part 1 (Bosutinib 600mg cohort) continued in Part 2 of the study.
- group Id
- FG009
- num Subjects
- 79
- group Id
- FG010
- num Subjects
- 64
- group Id
- FG011
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 60
- group Id
- FG004
- num Subjects
- 39
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 16
- group Id
- FG007
- num Subjects
- 21
- group Id
- FG008
- num Subjects
- 12
- group Id
- FG009
- num Subjects
- 30
- group Id
- FG010
- num Subjects
- 15
- group Id
- FG011
- num Subjects
- 1
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 135
- group Id
- FG004
- num Subjects
- 50
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 22
- group Id
- FG007
- num Subjects
- 29
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 49
- group Id
- FG010
- num Subjects
- 49
- group Id
- FG011
- num Subjects
- 23
- type
- NOT COMPLETED
- title
- Period 2: Part 2 (Efficacy)
Complete source fields
- groups
- description
- Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML) Part 2 of the study.
- id
- FG000
- title
- Bosutinib 400 mg (Part 1)
- description
- Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
- id
- FG001
- title
- Bosutinib 500 mg (Part 1)
- description
- Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase (AP) CML Part 2 of the study.
- id
- FG002
- title
- Bosutinib 600 mg (Part 1)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
- id
- FG003
- title
- Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
- id
- FG004
- title
- Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
- id
- FG005
- title
- Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
- id
- FG006
- title
- Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
- id
- FG007
- title
- Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
- id
- FG008
- title
- Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
- description
- All participants who received bosutinib 500 mg orally once daily in AP CML who were IM R/I or multiple tyrosine kinase inhibitor (Multi-TKI): IM, D and/or NI R/I.
- id
- FG009
- title
- AP-CML Total (Part 2)
- description
- All participants who received bosutinib 500 mg orally once daily in blast phase (BP) CML who were IM R/I or Multi-TKI: IM, D and/or NI R/I.
- id
- FG010
- title
- BP-CML Total (Part 2)
- description
- Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
- id
- FG011
- title
- Bosutinib 500 mg, Ph+ ALL (Part 2)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Continued in to Part 2
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 3
- group Id
- FG002
- num Subjects
- 12
- group Id
- FG003
- num Subjects
- 0
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- NOT COMPLETED
- title
- Period 1: Part 1 (Dose Escalation)
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 1
- group Id
- FG004
- num Subjects
- 0
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 0
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 0
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Discontinuation of study by sponsor
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 9
- group Id
- FG004
- num Subjects
- 8
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 3
- group Id
- FG007
- num Subjects
- 3
- group Id
- FG008
- num Subjects
- 0
- group Id
- FG009
- num Subjects
- 2
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 12
- group Id
- FG004
- num Subjects
- 4
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 0
- group Id
- FG008
- num Subjects
- 1
- group Id
- FG009
- num Subjects
- 4
- group Id
- FG010
- num Subjects
- 4
- group Id
- FG011
- num Subjects
- 0
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 15
- group Id
- FG004
- num Subjects
- 4
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 1
- group Id
- FG007
- num Subjects
- 5
- group Id
- FG008
- num Subjects
- 4
- group Id
- FG009
- num Subjects
- 4
- group Id
- FG010
- num Subjects
- 0
- group Id
- FG011
- num Subjects
- 0
- type
- Other
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 37
- group Id
- FG004
- num Subjects
- 7
- group Id
- FG005
- num Subjects
- 1
- group Id
- FG006
- num Subjects
- 10
- group Id
- FG007
- num Subjects
- 12
- group Id
- FG008
- num Subjects
- 3
- group Id
- FG009
- num Subjects
- 30
- group Id
- FG010
- num Subjects
- 44
- group Id
- FG011
- num Subjects
- 22
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 61
- group Id
- FG004
- num Subjects
- 27
- group Id
- FG005
- num Subjects
- 0
- group Id
- FG006
- num Subjects
- 4
- group Id
- FG007
- num Subjects
- 9
- group Id
- FG008
- num Subjects
- 5
- group Id
- FG009
- num Subjects
- 9
- group Id
- FG010
- num Subjects
- 1
- group Id
- FG011
- num Subjects
- 1
- type
- Extension study
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- comment
- 17 participants from Part 1 (Bosutinib 400mg, 500mg, 600mg cohort) continued in Part 2 of the study.
- group Id
- FG003
- num Subjects
- 195
- group Id
- FG004
- num Subjects
- 89
- group Id
- FG005
- num Subjects
- 5
- group Id
- FG006
- num Subjects
- 38
- group Id
- FG007
- num Subjects
- 50
- group Id
- FG008
- num Subjects
- 26
- comment
- 1 participant from Part 1 (Bosutinib 600mg cohort) continued in Part 2 of the study.
- group Id
- FG009
- num Subjects
- 79
- group Id
- FG010
- num Subjects
- 64
- group Id
- FG011
- num Subjects
- 24
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 60
- group Id
- FG004
- num Subjects
- 39
- group Id
- FG005
- num Subjects
- 3
- group Id
- FG006
- num Subjects
- 16
- group Id
- FG007
- num Subjects
- 21
- group Id
- FG008
- num Subjects
- 12
- group Id
- FG009
- num Subjects
- 30
- group Id
- FG010
- num Subjects
- 15
- group Id
- FG011
- num Subjects
- 1
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 135
- group Id
- FG004
- num Subjects
- 50
- group Id
- FG005
- num Subjects
- 2
- group Id
- FG006
- num Subjects
- 22
- group Id
- FG007
- num Subjects
- 29
- group Id
- FG008
- num Subjects
- 14
- group Id
- FG009
- num Subjects
- 49
- group Id
- FG010
- num Subjects
- 49
- group Id
- FG011
- num Subjects
- 23
- type
- NOT COMPLETED
- title
- Period 2: Part 2 (Efficacy)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle