TriangleNCT02343120 · OUTCOME
Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanograms/milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Week 2 Day 1 pre-dose and 24 hours
Analysis population: The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
Groups in this outcome
Part 1: 40 mg QD
Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Part 1: 80 mg QD
Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Part 1: 160 mg QD
Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
Part 1 and Part 2: 160 mg BID
Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
Part 1 and Part 2: 320 mg QD
Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
| Group | Source count |
|---|---|
| Part 1: 40 mg QD | 3 |
| Part 1: 80 mg QD | 4 |
| Part 1: 160 mg QD | 5 |
| Part 1 and Part 2: 160 mg BID | 77 |
| Part 1 and Part 2: 320 mg QD | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: 40 mg QD | 75.7 | 36.2 | Not reported | Not reported | Not reported |
| Part 1: 80 mg QD | 169 | 50.0 | Not reported | Not reported | Not reported |
| Part 1: 160 mg QD | 387 | 60.7 | Not reported | Not reported | Not reported |
| Part 1 and Part 2: 160 mg BID | 299 | 56.1 | Not reported | Not reported | Not reported |
| Part 1 and Part 2: 320 mg QD | 533 | 55.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 36.2
- value
- 75.7
- group Id
- OG001
- spread
- 50.0
- value
- 169
- group Id
- OG002
- spread
- 60.7
- value
- 387
- group Id
- OG003
- spread
- 56.1
- value
- 299
- group Id
- OG004
- spread
- 55.0
- value
- 533
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 77
- group Id
- OG004
- value
- 72
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants received 40 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
- id
- OG000
- title
- Part 1: 40 mg QD
- description
- Participants received 80 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
- id
- OG001
- title
- Part 1: 80 mg QD
- description
- Participants received 160 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up
- id
- OG002
- title
- Part 1: 160 mg QD
- description
- Part 1: Participants received 160 mg of zanubrutinib twice daily (BID) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
- id
- OG003
- title
- Part 1 and Part 2: 160 mg BID
- description
- Part 1: Participants received 320 mg of zanubrutinib once daily (QD) orally until disease progression, intolerance or death, withdrawal of consent, or loss to follow-up. Part 2: This dose regimen was selected for further evaluation in various expansion cohorts that span multiple disease types.
- id
- OG004
- title
- Part 1 and Part 2: 320 mg QD
- param Type
- GEOMETRIC_MEAN
- population Description
- The PK analysis set included all participants for whom valid zanubrutinib PK parameters could be estimated, shown as overall number analyzed. Only participants with available data per dose were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Week 2 Day 1 pre-dose and 24 hours
- title
- Part 1 and Part 2: Maximum Observed Plasma Concentration (Cmax) After Administration of Zanubrutinib
- type
- SECONDARY
- unit Of Measure
- nanograms/milliliter
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice