TriangleNCT02663518 · OUTCOME
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
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
- Part 1: Day 1 of dosing up to Pre-dose on Day 22
What was measured
DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (\<) 1.0 \* 10\^9/L. fever greater than (\>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
Analysis population: The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, or participants who experienced an AE, meeting DLT criteria during that time. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
Groups in this outcome
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
| Group | Source count |
|---|---|
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 3 |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 3 |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 5 |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg | 2 | 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
- 1
- group Id
- OG003
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 5
- units
- Participants
- description
- DLT was defined as any of the protocol specified TEAEs that occurred during the 21-day. DLT treatment/observation period (including the pre-dose tests on Day 22/Week 4 Day 1) and that were considered at least possibly related to study treatment by the investigator. Protocol specified DLT TEAE criteria: Grade 4 thrombocytopenia; Grade 3 thrombocytopenia with bleeding (with the exception of brief, easily-controlled epistaxis, mild gum bleeding or normal menses) or with any requirement for platelet transfusions; Grade 4 anemia, unexplained by underlying disease; Grade 4 neutropenia lasting more than 5 days; Febrile neutropenia of any duration ( Absolute Neutrophil Count (ANC) less than (\<) 1.0 \* 10\^9/L. fever greater than (\>) 38.5° Degree Celsius (C); Grade 3 or higher non-hematologic toxicity except for alopecia and nausea controlled by medical management; Grade 3 or 4 hemorrhage.
- groups
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.05 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG000
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.05 mg/kg
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.1 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG001
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.1 mg/kg
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.2 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG002
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.2 mg/kg
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.3 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG003
- title
- Part 1: Ontorpacept (PF-07901800/TTI-621) 0.3 mg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The DLT-evaluable set included participants who had received all 3 doses within the DLT evaluation period, or participants who experienced an AE, meeting DLT criteria during that time. Here, "Number of Participants Analyzed" refers to participants evaluable for this outcome measure.
- reporting Status
- POSTED
- time Frame
- Part 1: Day 1 of dosing up to Pre-dose on Day 22
- title
- Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice