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NCT02933320 · OUTCOME

Measurement of PK Parameter Maximum Observed Serum Concentration (Cmax) 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
ng/mL
Interval / dispersion
Full Range
Time frame
Doses 1 and 4 (pre-infusion, end of infusion, +4, +24, +48 and +72 hours)

What was measured

Maximum observed serum concentration 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 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase6075Not reported31.213100Not reported
100 mg BI-1206 (Cohort 2) Dose 1
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase15600Not reported699019300Not reported
100 mg BI-1206 (Cohort 2) Dose 4
Values in ng/mL · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part A: Arm 1: BI-1206 Single Agent Dose Escalation Phase12700Not reported885022500Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        31.2
        upper Limit
        13100
        value
        6075
    title
    0.4 - 50 mg BI-1206 (Cohort 1, intra patient dose escalation)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        6990
        upper Limit
        19300
        value
        15600
    title
    100 mg BI-1206 (Cohort 2) Dose 1
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        8850
        upper Limit
        22500
        value
        12700
    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
Maximum observed serum concentration 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 Maximum Observed Serum Concentration (Cmax) for BI-1206
type
SECONDARY
unit Of Measure
ng/mL

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Preserved source evidence · Not medical advice