TriangleNCT02257567 · OUTCOME
Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin (Lyophilized)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks
What was measured
PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
Analysis population: As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.
Groups in this outcome
Arm G (Phase II NF Cohort): Pola+BR in DLBCL
Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
| Group | Source count |
|---|---|
| Arm G (Phase II NF Cohort): Pola+BR in DLBCL | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
- groups
- description
- Participants with DLBCL received pola (lyophilized formulation), 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and rituximab, 375 mg/m\^2, as IV infusion on Day 1 of Cycles 1 to 6, in combination with pola.
- id
- OG000
- title
- Arm G (Phase II NF Cohort): Pola+BR in DLBCL
- population Description
- As pre-specified in the protocol the analysis of this OM was based on sponsor's discretion however, sponsor opted to not collect data for this OM.
- reporting Status
- POSTED
- time Frame
- Days 2, 8 and 15 of Cycle 1, Day 1 of Cycle 2 and 4, Day (cycle length is 21 days for DLBCL cohorts) up to approximately 9 weeks
- title
- Arm G (Phase II NF Cohort): Steady-State Volume of Distribution (Vss) of Polatuzumab Vedotin (Lyophilized)
- type
- PRIMARY
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice