TriangleNCT02042443 · OUTCOME
Objective Response Rate
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 2 years from registration
What was measured
Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
Analysis population: All eligible and analyzable patients with measurable disease.
Groups in this outcome
Trametinib
Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Chemotherapy
Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
| Group | Source count |
|---|---|
| Trametinib | 24 |
| Chemotherapy | 20 |
Reported measurements
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 0 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 2 | Not reported | Not reported | Not reported | Not reported |
Unconfirmed Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 2 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 0 | Not reported | Not reported | Not reported | Not reported |
Stable/No Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 2 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 9 | Not reported | Not reported | Not reported | Not reported |
Increasing Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 19 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 8 | Not reported | Not reported | Not reported | Not reported |
Symptomatic Deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trametinib | 1 | Not reported | Not reported | Not reported | Not reported |
| Chemotherapy | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- title
- Unconfirmed Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 9
- title
- Stable/No Response
- categories
- measurements
- group Id
- OG000
- value
- 19
- group Id
- OG001
- value
- 8
- title
- Increasing Disease
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Symptomatic Deterioration
- denoms
- counts
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 20
- units
- Participants
- description
- Confirmed response (CR) is two or more objective statuses of CR a minimum of four weeks apart documented before progression or symptomatic deterioration. Partial response (PR) is two or more objective statuses of PR or better a minimum of four weeks apart documented before progression or symptomatic deterioration. Unconfirmed CR is one objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR. Unconfirmed PR is one objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.
- groups
- description
- Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG000
- title
- Trametinib
- description
- Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- id
- OG001
- title
- Chemotherapy
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All eligible and analyzable patients with measurable disease.
- reporting Status
- POSTED
- time Frame
- Up to 2 years from registration
- title
- Objective Response Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice