TriangleNCT02663518 · OUTCOME
Part 4: Maximum Plasma Concentration (Cmax) of TTI-621
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- Nanogram per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
Analysis population: The Pharmacokinetic (PK)-evaluable Set consists of treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Groups in this outcome
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
| Group | Source count |
|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 3 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 3 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 5 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 2 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg | 10 |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg | 4040 | 110 | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg | 6190 | 1100 | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg | 10000 | 4400 | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg | 15400 | 2470 | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg | 23600 | 4530 | Not reported | Not reported | Not reported |
| Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg | 18800 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 110
- value
- 4040
- group Id
- OG001
- spread
- 1100
- value
- 6190
- group Id
- OG002
- spread
- 4400
- value
- 10000
- group Id
- OG003
- spread
- 2470
- value
- 15400
- group Id
- OG004
- spread
- 4530
- value
- 23600
- group Id
- OG005
- value
- 18800
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 10
- group Id
- OG005
- value
- 1
- units
- Participants
- dispersion Type
- Standard Deviation
- groups
- description
- Participants with relapsed or refractory CTCL received TTI-621 0.5 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG000
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 0.5 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 0.7 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG001
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 0.7 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 1.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG002
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 1.0 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 1.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG003
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 1.4 mg/kg
- description
- Participants with relapsed or refractory CTCL received TTI-621 2.0 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG004
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) 2.0 mg/kg
- description
- Participants with relapsed or refractory CTCL received a 2.0 mg/kg TTI-621 infusion once every 2 weeks until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG005
- title
- Part 4: Ontorpacept (PF-07901800/TTI-621) Q2W / 2.0 mg/kg
- param Type
- MEAN
- population Description
- The Pharmacokinetic (PK)-evaluable Set consists of treated participants with adequate blood sampling to estimate at least one pharmacokinetic PK parameter. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Part 4: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
- title
- Part 4: Maximum Plasma Concentration (Cmax) of TTI-621
- type
- SECONDARY
- unit Of Measure
- Nanogram per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice