TriangleNCT02193958 · OUTCOME
Safety Assessed by Adverse Events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 12 months
What was measured
Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity
Groups in this outcome
Phase 1 Cohort 1: 50mg/m2
FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 1 Cohort 2: 100mg/m2
FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 1 Cohort 3: 200mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 1 Cohort 4: 300mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 1 Cohort 5: 400mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 1 Cohort 6: 500mg/m2
FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 1 Cohort 7: 400mg/m2
FF-10501-01 tablets BID every 21 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 1 Cohort 8: 400mg/m2
FF-10501-01 tablets BID for 28 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
Phase 2a Cohort 9: 400mg/m2
FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
| Group | Source count |
|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 3 |
| Phase 1 Cohort 2: 100mg/m2 | 3 |
| Phase 1 Cohort 3: 200mg/m2 | 4 |
| Phase 1 Cohort 4: 300mg/m2 | 4 |
| Phase 1 Cohort 5: 400mg/m2 | 7 |
| Phase 1 Cohort 6: 500mg/m2 | 5 |
| Phase 1 Cohort 7: 400mg/m2 | 5 |
| Phase 1 Cohort 8: 400mg/m2 | 7 |
| Phase 2a Cohort 9: 400mg/m2 | 17 |
Reported measurements
Any TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: 100mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: 200mg/m2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: 300mg/m2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 5: 400mg/m2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 6: 500mg/m2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 7: 400mg/m2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 8: 400mg/m2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Cohort 9: 400mg/m2 | 17 | Not reported | Not reported | Not reported | Not reported |
Any study drug related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: 100mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: 200mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: 300mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 5: 400mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 6: 500mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 7: 400mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 8: 400mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Cohort 9: 400mg/m2 | 14 | Not reported | Not reported | Not reported | Not reported |
Any serious TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: 100mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: 200mg/m2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: 300mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 5: 400mg/m2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 6: 500mg/m2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 7: 400mg/m2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 8: 400mg/m2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Cohort 9: 400mg/m2 | 11 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or 4 TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: 100mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: 200mg/m2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: 300mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 5: 400mg/m2 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 6: 500mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 7: 400mg/m2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 8: 400mg/m2 | 7 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Cohort 9: 400mg/m2 | 15 | Not reported | Not reported | Not reported | Not reported |
Grade 3 or 4 study drug related TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: 100mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: 200mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: 300mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 5: 400mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 6: 500mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 7: 400mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 8: 400mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Cohort 9: 400mg/m2 | 6 | Not reported | Not reported | Not reported | Not reported |
Interruption of study drug due to TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: 100mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: 200mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: 300mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 5: 400mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 6: 500mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 7: 400mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 8: 400mg/m2 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Cohort 9: 400mg/m2 | 7 | Not reported | Not reported | Not reported | Not reported |
Death due to TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Cohort 1: 50mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 2: 100mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 3: 200mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 4: 300mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 5: 400mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 6: 500mg/m2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 7: 400mg/m2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1 Cohort 8: 400mg/m2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 2a Cohort 9: 400mg/m2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 17
- title
- Any TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 14
- title
- Any study drug related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 11
- title
- Any serious TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 4
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 15
- title
- Grade 3 or 4 TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 6
- title
- Grade 3 or 4 study drug related TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 7
- title
- Interruption of study drug due to TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 3
- group Id
- OG008
- value
- 0
- title
- Death due to TEAEs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 7
- group Id
- OG005
- value
- 5
- group Id
- OG006
- value
- 5
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 17
- units
- Participants
- description
- Safety and tolerability assessed by adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicity (DLT), dose reductions, delays or withdrawals due to toxicity
- groups
- description
- FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG000
- title
- Phase 1 Cohort 1: 50mg/m2
- description
- FF-10501-01 tablets BID for 14 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG001
- title
- Phase 1 Cohort 2: 100mg/m2
- description
- FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG002
- title
- Phase 1 Cohort 3: 200mg/m2
- description
- FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG003
- title
- Phase 1 Cohort 4: 300mg/m2
- description
- FF-10501-01 tablets BID for 14 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG004
- title
- Phase 1 Cohort 5: 400mg/m2
- description
- FF-10501-01 tablets BID for 14 days of a 28-day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle (Cohorts 1-6). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG005
- title
- Phase 1 Cohort 6: 500mg/m2
- description
- FF-10501-01 tablets BID every 21 days of a 28 day cycle. FF-10501-01: FF-10501-01 will be administered orally on Days 1-21 of a 28-say cycle (Cohort 7). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG006
- title
- Phase 1 Cohort 7: 400mg/m2
- description
- FF-10501-01 tablets BID for 28 days of a 28-day cycle FF-10501-01: FF-10501-01 will be administered orally BID on Days 1-28 of a 28-day cycle (Cohort 8). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG007
- title
- Phase 1 Cohort 8: 400mg/m2
- description
- FF-10501-01 tablets BID for 21 days of a 28-day cycle. FF-10501-01 will be administered orally BID on Days 1-21 of a 28-day cycle (Cohorts 9). The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
- id
- OG008
- title
- Phase 2a Cohort 9: 400mg/m2
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- 12 months
- title
- Safety Assessed by Adverse Events
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice