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
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 184 |
|---|
Reported measurements
C1D22
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 181 |
|---|
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 40.9 | 37.2 | Not reported | Not reported | Not reported |
|---|
C3D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 184 |
|---|
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 70.1 | 49.8 | Not reported | Not reported | Not reported |
|---|
C5D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 139 |
|---|
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 97.4 | 50.8 | Not reported | Not reported | Not reported |
|---|
C7D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 97 |
|---|
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 118.0 | 64.9 | Not reported | Not reported | Not reported |
|---|
C9D1
Analysis denominator · Participants
| Group | Source count |
|---|
| mFOLFOX6 + Zolbetuximab | 58 |
|---|
Values in micrograms/mililiter (ug/mL) · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| mFOLFOX6 + Zolbetuximab | 135.0 | 56.2 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 37.2
- value
- 40.9
- title
- C1D22
- categories
- measurements
- group Id
- OG000
- spread
- 49.8
- value
- 70.1
- title
- C3D1
- categories
- measurements
- group Id
- OG000
- spread
- 50.8
- value
- 97.4
- title
- C5D1
- categories
- measurements
- group Id
- OG000
- spread
- 64.9
- value
- 118.0
- title
- C7D1
- categories
- measurements
- group Id
- OG000
- spread
- 56.2
- value
- 135.0
- title
- C9D1
- description
- Ctrough was defined as the predose concentration at the end of dosing interval.
- dispersion Type
- Standard Deviation
- groups
- 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)
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice