TriangleNCT02663518 · OUTCOME
Part 2 and 3 Combined: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) 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*hour per milliliter
- Interval / dispersion
- Standard Deviation
- Time frame
- Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
What was measured
Results for this outcome measure was reported for Part 2 and Part 3 combined.
Analysis population: PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure. Data for only those arms \[according to dose\] are reported for this outcome measure which had any evaluable participants.
Groups in this outcome
Part 2 and 3 Combined: 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 2 and 3 Combined: 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 2 and 3 Combined: 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.
Part 2 and 3 Combined: 0.4 mg/kg
Participants with advanced relapsed or refractory lymphomas received TTI-621 0.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
Part 2 and 3 Combined: 0.5 mg/kg
Participants with advanced 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.
| Group | Source count |
|---|---|
| Part 2 and 3 Combined: 0.1 mg/kg | 36 |
| Part 2 and 3 Combined: 0.2 mg/kg | 133 |
| Part 2 and 3 Combined: 0.3 mg/kg | 0 |
| Part 2 and 3 Combined: 0.4 mg/kg | 1 |
| Part 2 and 3 Combined: 0.5 mg/kg | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 and 3 Combined: 0.1 mg/kg | 9330 | 10300 | Not reported | Not reported | Not reported |
| Part 2 and 3 Combined: 0.2 mg/kg | 20000 | 10400 | Not reported | Not reported | Not reported |
| Part 2 and 3 Combined: 0.4 mg/kg | 16100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 10300
- value
- 9330
- group Id
- OG001
- spread
- 10400
- value
- 20000
- group Id
- OG003
- value
- 16100
- denoms
- counts
- group Id
- OG000
- value
- 36
- group Id
- OG001
- value
- 133
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- units
- Participants
- description
- Results for this outcome measure was reported for Part 2 and Part 3 combined.
- dispersion Type
- Standard Deviation
- groups
- 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
- OG000
- title
- Part 2 and 3 Combined: 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
- OG001
- title
- Part 2 and 3 Combined: 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
- OG002
- title
- Part 2 and 3 Combined: 0.3 mg/kg
- description
- Participants with advanced relapsed or refractory lymphomas received TTI-621 0.4 mg/kg infusion once weekly until disease progression, unacceptable toxicity, or other reasons for treatment discontinuation occurred.
- id
- OG003
- title
- Part 2 and 3 Combined: 0.4 mg/kg
- description
- Participants with advanced 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
- OG004
- title
- Part 2 and 3 Combined: 0.5 mg/kg
- param Type
- MEAN
- population Description
- PK -evaluable set included treated participants with adequate blood sampling to estimate at least one PK parameter. Here, "Number of participants analyzed" signifies number of evaluable participants for this outcome measure. Data for only those arms \[according to dose\] are reported for this outcome measure which had any evaluable participants.
- reporting Status
- POSTED
- time Frame
- Part 2 and 3: Pre-dose, end of infusion (EOI), 2, 4, 24, 72, 168 hours post dose on Week 1
- title
- Part 2 and 3 Combined: Area Under the Plasma Concentration Time Curve From Time Zero to 168 (AUC[0-168]) of TTI-621
- type
- SECONDARY
- unit Of Measure
- Nanogram*hour per milliliter
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice