TriangleNCT00441337 · OUTCOME
Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose
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
- Day 1 to Day 85
What was measured
Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).
Analysis population: All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
Groups in this outcome
0.3 mg/kg Nivolumab
0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
1 mg/kg Nivolumab
1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
3 mg/kg Nivolumab
3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
10 mg/kg Nivolumab
10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
| Group | Source count |
|---|---|
| 0.3 mg/kg Nivolumab | 6 |
| 1 mg/kg Nivolumab | 6 |
| 3 mg/kg Nivolumab | 5 |
| 10 mg/kg Nivolumab | 21 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 0.3 mg/kg Nivolumab | 6.7 | 21.6 | Not reported | Not reported | Not reported |
| 1 mg/kg Nivolumab | 16.0 | 32.1 | Not reported | Not reported | Not reported |
| 3 mg/kg Nivolumab | 60.0 | 27.6 | Not reported | Not reported | Not reported |
| 10 mg/kg Nivolumab | 196.3 | 19.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.6
- value
- 6.7
- group Id
- OG001
- spread
- 32.1
- value
- 16.0
- group Id
- OG002
- spread
- 27.6
- value
- 60.0
- group Id
- OG003
- spread
- 19.5
- value
- 196.3
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 21
- units
- Participants
- description
- Nivolumab in human serum was assayed during the period of known analyte stability and reported as final data for this study by PPD® (Richmond, Virginia) using a cross-validated enzyme-linked immunosorbent assay (ELISA) method. For the single dose (Day 1), serum concentrations of nivolumab were assessed: prior to dosing, at 30 minutes (during dosing), immediately post-dose, and 30 minutes post-infusion end time; at 1, 2, 4, 6, 8, 24, 48, and 72 hours post-infusion end time; and on Days 8, 15, 22, 29, 43, 57, 71, and 85. The pharmacokinetic (PK) parameter of Cmax was measured in micrograms per milliliter (µg/mL).
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- 0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG000
- title
- 0.3 mg/kg Nivolumab
- description
- 1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG001
- title
- 1 mg/kg Nivolumab
- description
- 3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG002
- title
- 3 mg/kg Nivolumab
- description
- 10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
- id
- OG003
- title
- 10 mg/kg Nivolumab
- param Type
- GEOMETRIC_MEAN
- population Description
- All participants who received at least 1 dose or any partial dose of nivolumab and had adequate PK profiles were included in the summary statistics.
- reporting Status
- POSTED
- time Frame
- Day 1 to Day 85
- title
- Geometric Mean Maximum Serum Concentration (Cmax) Observed Post-Single Dose
- type
- PRIMARY
- unit Of Measure
- µg/mL
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Preserved source evidence · Not medical advice