TriangleNCT02567422 · OUTCOME
Pharmacokinetic Characteristics of Berzosertib
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ratio
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to Day 5
What was measured
The maximum concentration ratio between Day -7 collections to Day 2 collections. Collection time points are baseline, 30 and 55 minutes after the start of M6620 infusion, 5, 15, 30 minutes, 1, 2, 4, 23 (Day 3), 48 (Day 4), and 72 hours (Day 5) after the end of M6620 infusion given on Day 2.
Analysis population: Based on samples collected. PK was only collected in the dose escalation phase. PK was not collected for participants in the dose expansion arm.
Groups in this outcome
Dose Level 1
Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
Dose Level 2
Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
Dose Level 3
Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
| Group | Source count |
|---|---|
| Dose Level 1 | 5 |
| Dose Level 2 | 0 |
| Dose Level 3 | 5 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0.75 | 1.7 | Not reported | Not reported | Not reported |
| Dose Level 3 | 1.02 | 1.5 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1.7
- value
- 0.75
- group Id
- OG002
- spread
- 1.5
- value
- 1.02
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- The maximum concentration ratio between Day -7 collections to Day 2 collections. Collection time points are baseline, 30 and 55 minutes after the start of M6620 infusion, 5, 15, 30 minutes, 1, 2, 4, 23 (Day 3), 48 (Day 4), and 72 hours (Day 5) after the end of M6620 infusion given on Day 2.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients received M6620 (VX-970, berzosertib) 120 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- id
- OG000
- title
- Dose Level 1
- description
- Patients received M6620 (VX-970, berzosertib) 160 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- id
- OG001
- title
- Dose Level 2
- description
- Patients received M6620 (VX-970, berzosertib) 200 mg/m2 by infusion in their arm weekly, cisplatin 40 mg/m2 IV weekly starting a week after M6620, and radiation therapy 70 Gy daily Monday-Friday also starting a week after M6620.
- id
- OG002
- title
- Dose Level 3
- param Type
- MEAN
- population Description
- Based on samples collected. PK was only collected in the dose escalation phase. PK was not collected for participants in the dose expansion arm.
- reporting Status
- POSTED
- time Frame
- Up to Day 5
- title
- Pharmacokinetic Characteristics of Berzosertib
- type
- SECONDARY
- unit Of Measure
- ratio
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice