TriangleNCT01064648 · OUTCOME
Response Rate by RECIST1.1 (Phase II)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of analyzed participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years. Best response is documented for as long as the patient remains on protocol treatment.
What was measured
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline.
Analysis population: Only eligible patients with baseline measurable disease per RECIST 1.1 were included in the analysis.
Groups in this outcome
Phase II Cisplatin-pemetrexed Cediranib 20mg
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
Phase II Cisplatin-pemetrexed Placebo
Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
| Group | Source count |
|---|---|
| Phase II Cisplatin-pemetrexed Cediranib 20mg | 35 |
| Phase II Cisplatin-pemetrexed Placebo | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase II Cisplatin-pemetrexed Cediranib 20mg | 26 | Not reported | 12 | 43 | Not reported |
| Phase II Cisplatin-pemetrexed Placebo | 15 | Not reported | 6 | 30 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.83
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.15
- p Value Comment
- 1-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 1.85
- statistical Comment
- Stratified Chi-square by performance status and histology.
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- 0.59
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 5.83
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.15
- p Value Comment
- 1-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 1.85
- statistical Comment
- Stratified Chi-square by performance status and histology.
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12
- upper Limit
- 43
- value
- 26
- group Id
- OG001
- lower Limit
- 6
- upper Limit
- 30
- value
- 15
- denoms
- counts
- group Id
- OG000
- value
- 35
- group Id
- OG001
- value
- 40
- units
- Participants
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Complete Response (CR), Disappearance of all measurable and non-measurable disease; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. All target measurable lesions must be assessed using the same techniques as baseline.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and cediranib maleate PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cediranib maleate alone PO QD in the absence of disease progression or unacceptable toxicity. Cediranib Maleate: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
- id
- OG000
- title
- Phase II Cisplatin-pemetrexed Cediranib 20mg
- description
- Patients receive pemetrexed disodium IV over 10 minutes and cisplatin IV over 2 hours on day 1 and placebo PO QD on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive placebo alone PO QD in the absence of disease progression or unacceptable toxicity. Placebo: Given orally Cisplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Pemetrexed Disodium: Given IV
- id
- OG001
- title
- Phase II Cisplatin-pemetrexed Placebo
- param Type
- NUMBER
- population Description
- Only eligible patients with baseline measurable disease per RECIST 1.1 were included in the analysis.
- reporting Status
- POSTED
- time Frame
- Disease assessment will be repeated every 6 weeks until disease progression, up to 3 years. Best response is documented for as long as the patient remains on protocol treatment.
- title
- Response Rate by RECIST1.1 (Phase II)
- type
- SECONDARY
- unit Of Measure
- percentage of analyzed participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice