TriangleNCT01064648 · OUTCOME
Disease Control Rate by RECIST 1.1 (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.Disease control rate 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; Stable Disease (STA): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA All target measurable lesions must be assessed using the same techniques as baseline.
Analysis population: Eligible patients with baseline eligible 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 | 74 | Not reported | 57 | 88 | Not reported |
| Phase II Cisplatin-pemetrexed Placebo | 80 | Not reported | 64 | 91 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.09
- p Value Comment
- 1-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 0.45
- statistical Comment
- Stratified Chi-Square by performance status and histology
- statistical Method
- Chi-squared
Complete source fields
- analyses
- ci Lower Limit
- 0.14
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.49
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.09
- p Value Comment
- 1-sided p-value
- param Type
- Odds Ratio (OR)
- param Value
- 0.45
- statistical Comment
- Stratified Chi-Square by performance status and histology
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 57
- upper Limit
- 88
- value
- 74
- group Id
- OG001
- lower Limit
- 64
- upper Limit
- 91
- value
- 80
- 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; Stable Disease (STA): Does not qualify for CR, PR, Progression or Symptomatic Deterioration. Disease Control Rate (DCR) = CR + PR + STA 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
- Eligible patients with baseline eligible 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.Disease control rate is documented for as long as the patient remains on protocol treatment.
- title
- Disease Control Rate by RECIST 1.1 (Phase II)
- type
- SECONDARY
- unit Of Measure
- percentage of analyzed participants
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Preserved source evidence · Not medical advice