NCT04105010 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG000
- title
- AZD4205 Group A
- description
- Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG001
- title
- AZD4205 Group B
- description
- Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG002
- title
- AZD4205 Group C
- description
- Group D: Open label AZD4205 at the 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG003
- title
- AZD4205 Group D
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 54
- 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
- 4
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 4
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 19
- type
- Other reason
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 28
- group Id
- FG001
- num Subjects
- 16
- group Id
- FG002
- num Subjects
- 7
- group Id
- FG003
- num Subjects
- 120
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 13
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 39
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 9
- group Id
- FG002
- num Subjects
- 2
- group Id
- FG003
- num Subjects
- 81
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- 171 enrolled participants met inclusion criteria and received study drug.
- recruitment Details
- DZ2019J0005 study includes 2 parts: Part A, the dose escalation and extension part (group A, B, C), and part B, dose expansion part (group D). 51 and 120 participants were recruited in Part A and Part B respectively, based on physician referral at 31 sites in the U.S., Australia, China and South Korea. The first participant was enrolled on 10-Sep-2019 and the last participant was enrolled on 23-Aug-2023.
Complete source fields
- groups
- description
- Group A: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG000
- title
- AZD4205 Group A
- description
- Group B: Open label AZD4205 at 250 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG001
- title
- AZD4205 Group B
- description
- Group C: Open label AZD4205 at 150 mg, once daily (Phase 1) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG002
- title
- AZD4205 Group C
- description
- Group D: Open label AZD4205 at the 150 mg (RP2D), once daily (Phase 2) AZD4205: AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
- id
- FG003
- title
- AZD4205 Group D
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 3
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 54
- 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
- 4
- type
- Lost to Follow-up
- reasons
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 1
- group Id
- FG002
- num Subjects
- 1
- group Id
- FG003
- num Subjects
- 4
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 4
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 0
- group Id
- FG003
- num Subjects
- 19
- type
- Other reason
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 28
- group Id
- FG001
- num Subjects
- 16
- group Id
- FG002
- num Subjects
- 7
- group Id
- FG003
- num Subjects
- 120
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 13
- group Id
- FG001
- num Subjects
- 7
- group Id
- FG002
- num Subjects
- 5
- group Id
- FG003
- num Subjects
- 39
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 15
- group Id
- FG001
- num Subjects
- 9
- group Id
- FG002
- num Subjects
- 2
- group Id
- FG003
- num Subjects
- 81
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- 171 enrolled participants met inclusion criteria and received study drug.
- recruitment Details
- DZ2019J0005 study includes 2 parts: Part A, the dose escalation and extension part (group A, B, C), and part B, dose expansion part (group D). 51 and 120 participants were recruited in Part A and Part B respectively, based on physician referral at 31 sites in the U.S., Australia, China and South Korea. The first participant was enrolled on 10-Sep-2019 and the last participant was enrolled on 23-Aug-2023.
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Preserved source evidence · Not medical advice
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