NCT02567422 · OUTCOME
Potential Drug-drug Interaction
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ug/L
- Interval / dispersion
- Standard Deviation
- Time frame
- Up to Day 5
What was measured
The maximum concentration of M6620 in the blood when aprepitant is also given.
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 | 732 | 2.5 | Not reported | Not reported | Not reported |
| Dose Level 3 | 1149 | 1.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.5
- value
- 732
- group Id
- OG002
- spread
- 1.9
- value
- 1149
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- units
- Participants
- description
- The maximum concentration of M6620 in the blood when aprepitant is also given.
- 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
- GEOMETRIC_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
- Potential Drug-drug Interaction
- type
- SECONDARY
- unit Of Measure
- ug/L
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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