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NCT02933320 · OUTCOME

Measurement of PK Parameter Total Body Clearance (CL) for BI-1206

BI-1206 and an Anti-CD20 Antibody in Patients With CD32b Positive B-cell Lymphoma or Leukaemia · Source last updated 2021-07-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
mL/h/kg
Interval / dispersion
Full Range
Time frame
Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)

What was measured

Total body clearance after intravenous BI-1206 administration

Analysis population: Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort.

Groups in this outcome

Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase

BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.

Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase

Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.

Part B: Arm1: BI-1206 Single Agent Expansion Phase

Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.

Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase

Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase12
Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase0
Part B: Arm1: BI-1206 Single Agent Expansion Phase0
Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase0

Reported measurements

0.4 - 2 mg BI-1206 (Cohort 1, starting dose and first intra patient escalation dose)
Values in mL/h/kg · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation PhaseNANot reportedNANACL could not be assessed at these dose levels as insufficient serum concentration values were above the lower limit of detection.
10 - 50 mg BI-1206 (Cohort 1 intra patient dose escalation)
Values in mL/h/kg · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase6.34Not reported2.4510.8Not reported
100 mg BI-1206 (Cohort 2) Dose 1
Values in mL/h/kg · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase3.32Not reported1.829.63Not reported
100 mg BI-1206 (Cohort 2) Dose 4
Values in mL/h/kg · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase7.44Not reported6.618.64Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        CL could not be assessed at these dose levels as insufficient serum concentration values were above the lower limit of detection.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
    title
    0.4 - 2 mg BI-1206 (Cohort 1, starting dose and first intra patient escalation dose)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.45
        upper Limit
        10.8
        value
        6.34
    title
    10 - 50 mg BI-1206 (Cohort 1 intra patient dose escalation)
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.82
        upper Limit
        9.63
        value
        3.32
    title
    100 mg BI-1206 (Cohort 2) Dose 1
  4. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6.61
        upper Limit
        8.64
        value
        7.44
    title
    100 mg BI-1206 (Cohort 2) Dose 4
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Total body clearance after intravenous BI-1206 administration
dispersion Type
Full Range
groups
  1. description
    BI-1206 given by IV infusion to all patients once weekly for a period of four weeks, patients will then have a follow-up period of four weeks (8 week period classified as induction therapy). BI-1206 single agent dose escalation phase: BI-1206 single agent dose escalation phase to determine the MTD or MAD and RP2D for evaluation of BI-1206.
    id
    OG000
    title
    Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase
  2. description
    Arm 2, an investigation of combination treatment of BI-1206 with rituximab, involving an initial assessment of the appropriate dose of BI-1206 that can be given in combination with rituximab (combination dose escalation cohorts). Combination of BI-1206 with rituximab escalation phase: An investigation of combination treatment of BI-1206 with rituximab.
    id
    OG001
    title
    Part A: Arm 2: Combination of BI-1206 With Rituximab Escalation Phase
  3. description
    Part B Arm 1, an expansion cohort of up to 25 patients treated with single agent BI-1206 at the RP2D as determined in Part A Arm 1. Expansion to include a minimum of 12 CLL patients and six MCL patients. BI-1206 single agent expansion phase: BI-1206 single agent expansion phase at the RP2D.
    id
    OG002
    title
    Part B: Arm1: BI-1206 Single Agent Expansion Phase
  4. description
    Part B Arm 2, an expansion cohort of up to 25 patients treated with a combination of BI-1206 and rituximab at the RP2D as determined in Part A Arm 2. Expansion to include a minimum of 12 CLL patients and six MCL patients. Combination of BI-1206 with rituximab expansion phase: BI-1206 in combination with rituximab at the RP2D.
    id
    OG003
    title
    Part B: Arm 2: Combination of BI-1206 With Rituximab Expansion Phase
param Type
MEDIAN
population Description
Patients who provided serum samples before and after receiving BI-1206 for pharmacokinetic evaluation. One patient was enrolled to Part A, Arm 2 but PK parameters could not be evaluated for this patient, as there were no post-dose samples taken for the patient recruited to this cohort.
reporting Status
POSTED
time Frame
Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)
title
Measurement of PK Parameter Total Body Clearance (CL) for BI-1206
type
SECONDARY
unit Of Measure
mL/h/kg

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Preserved source evidence · Not medical advice