TriangleNCT03043872 · OUTCOME
Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- micrograms/milliliter (μg/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
What was measured
To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
Analysis population: The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of investigational product (IP), per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.
Groups in this outcome
Global Cohort: D + T + EP
During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
Global Cohort: D + EP
During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
| Group | Source count |
|---|---|
| Global Cohort: D + T + EP | 257 |
| Global Cohort: D + EP | 261 |
Reported measurements
Week 0: peak concentration
| Group | Source count |
|---|---|
| Global Cohort: D + T + EP | 239 |
| Global Cohort: D + EP | 226 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Cohort: D + T + EP | 447.3 | 78.21 | Not reported | Not reported | Not reported |
| Global Cohort: D + EP | 502.6 | 30.52 | Not reported | Not reported | Not reported |
Week 3: trough concentration
| Group | Source count |
|---|---|
| Global Cohort: D + T + EP | 232 |
| Global Cohort: D + EP | 237 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Cohort: D + T + EP | 91.86 | 74.36 | Not reported | Not reported | Not reported |
| Global Cohort: D + EP | 109.5 | 64.55 | Not reported | Not reported | Not reported |
Week 12: trough concentration
| Group | Source count |
|---|---|
| Global Cohort: D + T + EP | 173 |
| Global Cohort: D + EP | 200 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Global Cohort: D + T + EP | 199.2 | 49.58 | Not reported | Not reported | Not reported |
| Global Cohort: D + EP | 239.3 | 50.68 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 78.21
- value
- 447.3
- group Id
- OG001
- spread
- 30.52
- value
- 502.6
- denoms
- counts
- group Id
- OG000
- value
- 239
- group Id
- OG001
- value
- 226
- units
- Participants
- title
- Week 0: peak concentration
- categories
- measurements
- group Id
- OG000
- spread
- 74.36
- value
- 91.86
- group Id
- OG001
- spread
- 64.55
- value
- 109.5
- denoms
- counts
- group Id
- OG000
- value
- 232
- group Id
- OG001
- value
- 237
- units
- Participants
- title
- Week 3: trough concentration
- categories
- measurements
- group Id
- OG000
- spread
- 49.58
- value
- 199.2
- group Id
- OG001
- spread
- 50.68
- value
- 239.3
- denoms
- counts
- group Id
- OG000
- value
- 173
- group Id
- OG001
- value
- 200
- units
- Participants
- title
- Week 12: trough concentration
- denoms
- counts
- group Id
- OG000
- value
- 257
- group Id
- OG001
- value
- 261
- units
- Participants
- description
- To evaluate PK, blood samples were collected at pre-specified timepoints and peak and trough serum concentrations of durvalumab were determined. Peak concentration on Week 0 is the post-infusion concentration of Week 0 (collected within 10 minutes of the end of infusion). Trough concentrations on Weeks 3 and 12 are the pre-infusion concentrations of Weeks 3 and 12, respectively.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- During Chemotherapy: Patients received durvalumab (D) 1500 mg in combination with tremelimumab (T) 75 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg IV infusion post-chemotherapy (in combination with durvalumab) at Week 16 if they completed all 4 doses of durvalumab + tremelimumab during chemotherapy.
- id
- OG000
- title
- Global Cohort: D + T + EP
- description
- During Chemotherapy: Patients received durvalumab (D) 1500 mg IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). For chemotherapy (EP), patients received etoposide (80-100 mg/m\^2) with either carboplatin (area under the curve 5-6) or cisplatin (75-80 mg/m\^2) IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Post-Chemotherapy: Patients then continued to receive durvalumab 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
- id
- OG001
- title
- Global Cohort: D + EP
- param Type
- GEOMETRIC_MEAN
- population Description
- The global PK analysis set included all patients randomized prior to the end of global recruitment who received at least 1 dose of investigational product (IP), per the protocol for whom any post-dose PK data were available. PK for durvalumab was performed for the D + T + EP and D + EP groups only.
- reporting Status
- POSTED
- time Frame
- Samples were collected post-dose on Day 1 (Week 0), and pre-dose on Weeks 3 and 12. Assessed at the global cohort final analysis DCO (27 January 2020).
- title
- Pharmacokinetics (PK) of Durvalumab; Peak and Trough Serum Concentrations in the Global Cohort
- type
- SECONDARY
- unit Of Measure
- micrograms/milliliter (μg/mL)
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Preserved source evidence · Not medical advice