TriangleNCT01326871 · OUTCOME
Objective Response Rate in Treated Patients
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- 12 weeks
What was measured
Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \[RECIST V1.0\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
Analysis population: Intent to treat population
Groups in this outcome
ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
ALT-801 0.06 mg/kg With Gemcitabine
Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
| Group | Source count |
|---|---|
| ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine | 3 |
| ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine | 49 |
| ALT-801 0.06 mg/kg With Gemcitabine | 16 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine | 100 | Not reported | 29 | 100 | Not reported |
| ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine | 47 | Not reported | 33 | 62 | Not reported |
| ALT-801 0.06 mg/kg With Gemcitabine | 6 | Not reported | 0 | 30 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29
- upper Limit
- 100
- value
- 100
- group Id
- OG001
- lower Limit
- 33
- upper Limit
- 62
- value
- 47
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 30
- value
- 6
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 49
- group Id
- OG002
- value
- 16
- units
- Participants
- description
- Objective response rate (ORR) is defined as confirmed complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors \[RECIST V1.0\]: a complete response is the disappearance of all target lesions; a partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
- id
- OG000
- title
- ALT-801 0.04 mg/kg With Cisplatin and Gemcitabine
- description
- Cisplatin: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given) Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
- id
- OG001
- title
- ALT-801 0.06 mg/kg With Cisplatin and Gemcitabine
- description
- Gemcitabine: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course ALT-801: Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
- id
- OG002
- title
- ALT-801 0.06 mg/kg With Gemcitabine
- param Type
- NUMBER
- population Description
- Intent to treat population
- reporting Status
- POSTED
- time Frame
- 12 weeks
- title
- Objective Response Rate in Treated Patients
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice