NCT02567422 · OUTCOME
Number of Participants Experiencing a Response
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 6.5 years
What was measured
Evaluated by Response Evaluation Criteria in Solid Tumors 1.1. Response is defined as complete response (disappearance of all target and non-target lesions) or partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
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.
Dose Level 3 Expansion
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 | 11 |
| Dose Level 2 | 6 |
| Dose Level 3 | 11 |
| Dose Level 3 Expansion | 15 |
Reported measurements
Source class 1
Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 9 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 7 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 Expansion | 7 | Not reported | Not reported | Not reported | Not reported |
No Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 1 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 Expansion | 3 | Not reported | Not reported | Not reported | Not reported |
Not Performed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 | 2 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 | 3 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 Expansion | 5 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 7
- title
- Response
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 3
- title
- No Response
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 5
- title
- Not Performed
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 15
- units
- Participants
- description
- Evaluated by Response Evaluation Criteria in Solid Tumors 1.1. Response is defined as complete response (disappearance of all target and non-target lesions) or partial response (at least a 30% decrease in the sum of diameters of target lesions from baseline).
- 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
- 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
- OG003
- title
- Dose Level 3 Expansion
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Up to 6.5 years
- title
- Number of Participants Experiencing a Response
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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