TriangleNCT02601209 · OUTCOME
Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years
What was measured
Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD.
Analysis population: Phase II Analysis Group 2 - Initial Treatment Period; Only patients that had a complete response or partial response are included in this analysis.
Groups in this outcome
Phase II - Analysis Group 2 MLN0128
Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
Phase II - Analysis Group 2 Pazopanib
Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
| Group | Source count |
|---|---|
| Phase II - Analysis Group 2 MLN0128 | 2 |
| Phase II - Analysis Group 2 Pazopanib | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II - Analysis Group 2 MLN0128 | 0.9 | Not reported | 0 | 1.84 | Not reported |
| Phase II - Analysis Group 2 Pazopanib | 1.8 | Not reported | 0 | 3.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 1.84
- value
- 0.9
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 3.6
- value
- 1.8
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- Duration of response is defined as the time between each patient's best tumor response and progression (or date of last disease assessment for patients who die without progression or are lost to follow-up). Complete Response (CR): All of the following must be true: a. Disappearance of all target lesions. b. Each target lymph node must have reduction in short axis to \< 1.0 cm. Partial Response (PR): At least a 30% decrease in PBSD taking as reference the BSD.
- dispersion Type
- Full Range
- groups
- description
- Protocol therapy will consist of 30 mg MLN0128 (TAK-228) administered weekly over a 4-week cycle.
- id
- OG000
- title
- Phase II - Analysis Group 2 MLN0128
- description
- Patients receive 400mg Pazopanib orally once daily over a 4-week cycle and titrated to tolerance (maximum 800mg) by the treating physician in the first intervention period/initial treatment period.
- id
- OG001
- title
- Phase II - Analysis Group 2 Pazopanib
- param Type
- MEDIAN
- population Description
- Phase II Analysis Group 2 - Initial Treatment Period; Only patients that had a complete response or partial response are included in this analysis.
- reporting Status
- POSTED
- time Frame
- Time between each patient's best tumor response and progression(or date of last disease assessment for patients who die without progression or are lost to follow-up), assessed up to 2 years
- title
- Duration of Response (Phase II Analysis Group 2 - Initial Treatment Period)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice