TriangleNCT03112174 · OUTCOME
Steady-State PK of Ibrutinib: Area Under the Concentration-Time Curve From 0-24 Hours (AUC0-24) (Randomization Phase)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng·h/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose
What was measured
Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
Analysis population: Participants with an evaluable PK assessment at given time point.
Groups in this outcome
Randomization Phase: Ibrutinb + Venetoclax
Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
Randomization Phase: Ibrutinib + Placebo
Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
| Group | Source count |
|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 102 |
| Randomization Phase: Ibrutinib + Placebo | 106 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Randomization Phase: Ibrutinb + Venetoclax | 1090 | 870 | Not reported | Not reported | Not reported |
| Randomization Phase: Ibrutinib + Placebo | 1440 | 1060 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 870
- value
- 1090
- group Id
- OG001
- spread
- 1060
- value
- 1440
- denoms
- counts
- group Id
- OG000
- value
- 102
- group Id
- OG001
- value
- 106
- units
- Participants
- description
- Pre-dose concentrations were applied as 24-hour concentrations in order to calculate steady-state PK parameters.
- dispersion Type
- Standard Deviation
- groups
- description
- Participants were randomized to ibrutinib 560 mg and venetoclax (starting at 20 mg, and gradually ramped up to a target dose of 400 mg) for approximately 104 weeks, followed by ibrutinib monotherapy until disease progression (PD), unacceptable toxicity or withdrawal of consent. Venetoclax was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG000
- title
- Randomization Phase: Ibrutinb + Venetoclax
- description
- Participants were randomized to ibrutinib 560 mg and placebo for approximately 104 weeks, followed by ibrutinib monotherapy until PD, unacceptable toxicity or withdrawal of consent. Placebo was discontinued after 104 weeks of treatment, regardless of response assessment.
- id
- OG001
- title
- Randomization Phase: Ibrutinib + Placebo
- param Type
- MEAN
- population Description
- Participants with an evaluable PK assessment at given time point.
- reporting Status
- POSTED
- time Frame
- Week 6, Day 1: Predose, at Dose, 1 hour (± 15 minutes [min]), 2 hours (± 15 min), 4 hours (± 30 min), 6 hours (± 30 min), 8 hours (± 1 hour), 24 hours post-dose
- title
- Steady-State PK of Ibrutinib: Area Under the Concentration-Time Curve From 0-24 Hours (AUC0-24) (Randomization Phase)
- type
- SECONDARY
- unit Of Measure
- ng·h/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice