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NCT01010061 · OUTCOME

Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)

CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1a) · Source last updated 2018-09-14

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

Measure
GEOMETRIC_MEAN
Unit
μg/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)

What was measured

Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).

Analysis population: PK population includes all participants with PK data available at the given time-point.

Groups in this outcome

Obinutuzumab + Chlorambucil (GClb)

Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).

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

Analysis denominator · Participants

GroupSource count
Obinutuzumab + Chlorambucil (GClb)220

Reported measurements

Post-dose Cycle 1 (n=201)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)24741.6Not reportedNot reportedNot reported
Pre-dose Cycle 2 (n=198)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)22757.9Not reportedNot reportedNot reported
Post-dose Cycle 2 (n=197)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)58736.5Not reportedNot reportedNot reported
Pre-dose Cycle 3 (n=193)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)16568.7Not reportedNot reportedNot reported
Post-dose Cycle 3 (n=192)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)52739.7Not reportedNot reportedNot reported
Pre-dose Cycle 4 (n=191)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)15674.3Not reportedNot reportedNot reported
Post-dose Cycle 4 (n=189)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)53541.0Not reportedNot reportedNot reported
Pre-dose Cycle 5 (n=185)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)16372.4Not reportedNot reportedNot reported
Post-dose Cycle 5 (n=181)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)53439.1Not reportedNot reportedNot reported
Pre-dose Cycle 6 (n=185)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)18169.0Not reportedNot reportedNot reported
Post-dose Cycle 6 (n=183)
Values in μg/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Obinutuzumab + Chlorambucil (GClb)52539.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.6
        value
        247
    title
    Post-dose Cycle 1 (n=201)
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        57.9
        value
        227
    title
    Pre-dose Cycle 2 (n=198)
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        36.5
        value
        587
    title
    Post-dose Cycle 2 (n=197)
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        68.7
        value
        165
    title
    Pre-dose Cycle 3 (n=193)
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.7
        value
        527
    title
    Post-dose Cycle 3 (n=192)
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        74.3
        value
        156
    title
    Pre-dose Cycle 4 (n=191)
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        41.0
        value
        535
    title
    Post-dose Cycle 4 (n=189)
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        72.4
        value
        163
    title
    Pre-dose Cycle 5 (n=185)
  9. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.1
        value
        534
    title
    Post-dose Cycle 5 (n=181)
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        69.0
        value
        181
    title
    Pre-dose Cycle 6 (n=185)
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        39.6
        value
        525
    title
    Post-dose Cycle 6 (n=183)
denoms
  1. counts
    1. group Id
      OG000
      value
      220
    units
    Participants
description
Blood samples were collected from all patients allocated to the GClb treatment arm pre- and post-dose Day 1 of Cycles 1 to 6 and were sent to a laboratory. The concentration of obinutzumab in serum was determined using a validated enzyme-linked immunosorbent assay (ELISA) and was reported in micrograms/milliliter (μg/mL).
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
    id
    OG000
    title
    Obinutuzumab + Chlorambucil (GClb)
param Type
GEOMETRIC_MEAN
population Description
PK population includes all participants with PK data available at the given time-point.
reporting Status
POSTED
time Frame
Pre- and post-dose sampling on day 1 of cycles 1-6 (Up to 26.8 months)
title
Pharmacokinetics of Obinutuzumab (RO5072759) in Combination With Chlorambucil (Clb)
type
SECONDARY
unit Of Measure
μg/mL

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Preserved source evidence · Not medical advice