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NCT03504397 · OUTCOME

Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)

A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. · Source last updated 2026-05-04

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

Measure
MEAN
Unit
micrograms/mililiter (ug/mL)
Interval / dispersion
Standard Deviation
Time frame
Predose on C1D22, C3D1, C5D1, C7D1, C9D1

What was measured

Ctrough was defined as the predose concentration at the end of dosing interval.

Analysis population: PKAS consisted of the subset of the SAF for which at least 1 zolbetuximab concentration measurement was available. Participants with available data at each timepoint were analyzed.

Groups in this outcome

mFOLFOX6 + Zolbetuximab

Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.

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

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab184

Reported measurements

C1D22

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab181
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab40.937.2Not reportedNot reportedNot reported
C3D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab184
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab70.149.8Not reportedNot reportedNot reported
C5D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab139
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab97.450.8Not reportedNot reportedNot reported
C7D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab97
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab118.064.9Not reportedNot reportedNot reported
C9D1

Analysis denominator · Participants

GroupSource count
mFOLFOX6 + Zolbetuximab58
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
mFOLFOX6 + Zolbetuximab135.056.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        37.2
        value
        40.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        181
      units
      Participants
    title
    C1D22
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        49.8
        value
        70.1
    denoms
    1. counts
      1. group Id
        OG000
        value
        184
      units
      Participants
    title
    C3D1
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        50.8
        value
        97.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        139
      units
      Participants
    title
    C5D1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        64.9
        value
        118.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        97
      units
      Participants
    title
    C7D1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        56.2
        value
        135.0
    denoms
    1. counts
      1. group Id
        OG000
        value
        58
      units
      Participants
    title
    C9D1
denoms
  1. counts
    1. group Id
      OG000
      value
      184
    units
    Participants
description
Ctrough was defined as the predose concentration at the end of dosing interval.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received an IV infusion (as a minimum of 2-hour infusion) of zolbetuximab at a loading dose of 800 mg/m\^2 on C1D1 followed by subsequent doses of 600 mg/m\^2 every 3 weeks starting from C1D22 until participant meets study treatment discontinuation criteria. Participants also received up to 12 treatments of 5-fluorouracil, folinic acid and oxaliplatin (mFOLFOX6) (or components of mFOLFOX6 if some components were discontinued due to toxicity) over 4 or more cycles in which mFOLFOX6 was administered on Days 1, 15 and 29 of each cycle (5-fluorouracil administered by IV bolus 400 mg/m\^2 over 5 to 15 minutes followed by 2400mg/m\^2 over 46-48 hours continuous IV infusion every 2 weeks for 4 cycles. Folinic acid administered 400 mg/m\^2 IV infusion over 2 hours; oxaliplatin administered 85 mg/m\^2 IV infusion over 2 hours). A maximum of 12 doses of oxaliplatin was permitted. After mFOLFOX6 treatments, participants could continue to receive 5-FU and folinic acid on Days 1, 15 and 29 of each cycle at the investigator's discretion or until the participant met the study treatment discontinuation criteria. Each cycle was approximately 42 days.
    id
    OG000
    title
    mFOLFOX6 + Zolbetuximab
param Type
MEAN
population Description
PKAS consisted of the subset of the SAF for which at least 1 zolbetuximab concentration measurement was available. Participants with available data at each timepoint were analyzed.
reporting Status
POSTED
time Frame
Predose on C1D22, C3D1, C5D1, C7D1, C9D1
title
Pharmacokinetics (PK) of Zolbetuximab in Serum: Trough Concentration (Ctrough)
type
SECONDARY
unit Of Measure
micrograms/mililiter (ug/mL)

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Preserved source evidence · Not medical advice