TriangleNCT01970865 · OUTCOME
Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1
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
- Cycle 1 (21 days)
What was measured
DLT: any of following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for \>7 days; febrile neutropenia; grade\>=3 neutropenic infection; grade\>=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade\>=3 pancreatitis; grade\>=3 toxicities (excluding grade \>=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade \>=3 QT interval corrected for heart rate (QTc) prolongation, or asymptomatic grade \>=3 prolongation that had been confirmed by repeat testing, re-evaluation by qualified person, persisted after correction of reversible causes; \>=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of 21 prescribed daily total dose due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicity attributable to study drug.
Analysis population: Maximum Tolerated Dose (MTD) evaluable population included all enrolled participants who received at least 75% of the planned PF-06463922 doses in Cycle 1. Participants who received less than 75% of the planned PF-06463922 doses in Cycle 1 due to DLT were also considered evaluable for MTD. Here, "Overall Number Analyzed" signifies participants analyzed for this outcome measure.
Groups in this outcome
10 mg QD (Phase 1)
PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
25 mg QD (Phase 1)
PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
50 mg QD (Phase 1)
PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
75 mg QD (Phase 1)
PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
100 mg QD (Phase 1)
PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
150 mg QD (Phase 1)
PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
200 mg QD (Phase 1)
PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
35 mg BID (Phase 1)
PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
75 mg BID (Phase 1)
PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
100 mg BID (Phase 1)
PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
| Group | Source count |
|---|---|
| 10 mg QD (Phase 1) | 3 |
| 25 mg QD (Phase 1) | 3 |
| 50 mg QD (Phase 1) | 3 |
| 75 mg QD (Phase 1) | 11 |
| 100 mg QD (Phase 1) | 16 |
| 150 mg QD (Phase 1) | 3 |
| 200 mg QD (Phase 1) | 3 |
| 35 mg BID (Phase 1) | 2 |
| 75 mg BID (Phase 1) | 3 |
| 100 mg BID (Phase 1) | 3 |
Reported measurements
With DLT
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
No DLT
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 6 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 8 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 3 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 2 | Not reported | Not reported | Not reported | Not reported |
Data missing
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 10 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 25 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 50 mg QD (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg QD (Phase 1) | 5 | Not reported | Not reported | Not reported | Not reported |
| 100 mg QD (Phase 1) | 8 | Not reported | Not reported | Not reported | Not reported |
| 150 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 200 mg QD (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
| 35 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 75 mg BID (Phase 1) | 0 | Not reported | Not reported | Not reported | Not reported |
| 100 mg BID (Phase 1) | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 0
- title
- With DLT
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 6
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 2
- title
- No DLT
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 8
- group Id
- OG005
- value
- 1
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- title
- Data missing
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 16
- group Id
- OG005
- value
- 3
- group Id
- OG006
- value
- 3
- group Id
- OG007
- value
- 2
- group Id
- OG008
- value
- 3
- group Id
- OG009
- value
- 3
- units
- Participants
- description
- DLT: any of following adverse events (AEs) attributable to PF-06463922: (1) hematologic: grade 4 neutropenia for \>7 days; febrile neutropenia; grade\>=3 neutropenic infection; grade\>=3 thrombocytopenia with bleeding; grade 4 thrombocytopenia; (2) non-hematologic: grade\>=3 pancreatitis; grade\>=3 toxicities (excluding grade \>=3 laboratory abnormalities not requiring dose modifications) persisting after optimal treatment with standard medical therapy; symptomatic grade \>=3 QT interval corrected for heart rate (QTc) prolongation, or asymptomatic grade \>=3 prolongation that had been confirmed by repeat testing, re-evaluation by qualified person, persisted after correction of reversible causes; \>=20% decrease from baseline in left ventricular ejection fraction (LVEF); (3) other: failure to deliver at least 16 out of 21 prescribed daily total dose due to toxicities attributable to study drug; failure to restart dosing after 21 days (1 cycle) delay due to toxicity attributable to study drug.
- groups
- description
- PF-06463922 10 mg was orally given once daily (QD) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG000
- title
- 10 mg QD (Phase 1)
- description
- PF-06463922 25 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG001
- title
- 25 mg QD (Phase 1)
- description
- PF-06463922 50 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG002
- title
- 50 mg QD (Phase 1)
- description
- PF-06463922 75 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG003
- title
- 75 mg QD (Phase 1)
- description
- PF-06463922 100 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG004
- title
- 100 mg QD (Phase 1)
- description
- PF-06463922 150 mg was orally given QD in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal. Midazolam 2 mg was orally given QD on Day -7 and Cycle 1 Day 15.
- id
- OG005
- title
- 150 mg QD (Phase 1)
- description
- PF-06463922 200 mg was orally given QD on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG006
- title
- 200 mg QD (Phase 1)
- description
- PF-06463922 35 mg was orally given twice daily (BID) on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG007
- title
- 35 mg BID (Phase 1)
- description
- PF-06463922 75 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG008
- title
- 75 mg BID (Phase 1)
- description
- PF-06463922 100 mg was orally given BID on Day -7 and in 21-day cycles from Cycle 1 Day 1 until progression of disease (unless clinical benefit was still achievable), unacceptable toxicity, death or consent withdrawal.
- id
- OG009
- title
- 100 mg BID (Phase 1)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Maximum Tolerated Dose (MTD) evaluable population included all enrolled participants who received at least 75% of the planned PF-06463922 doses in Cycle 1. Participants who received less than 75% of the planned PF-06463922 doses in Cycle 1 due to DLT were also considered evaluable for MTD. Here, "Overall Number Analyzed" signifies participants analyzed for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Cycle 1 (21 days)
- title
- Number of Participants With Cycle 1 Dose-Limiting Toxicities (DLTs) in Phase 1
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice