TriangleNCT03245450 · OUTCOME
Phase 2: Objective Response Rate (ORR)
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
- 90% Confidence Interval
- Time frame
- From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or up to approximately 2 years 4 months
What was measured
ORR was defined as the percentage of participants achieving best overall response (BOR) of confirmed partial response (PR) or complete response (CR) determined by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeter (mm). PR was at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters.
Analysis population: Full analysis set included all participants who received at least 1 dose of either study drug.
Groups in this outcome
Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
Participants with RMS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
Participants with NRSTS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
Participants with EWS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
| Group | Source count |
|---|---|
| Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 9 |
| Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 9 |
| Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 11.1 | 0.6 | 0.6 | 42.9 | Not reported |
| Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 11.1 | 0.6 | 0.6 | 42.9 | Not reported |
| Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2 | 11.1 | 0.6 | 0.6 | 42.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.6
- spread
- 0.6
- upper Limit
- 42.9
- value
- 11.1
- group Id
- OG001
- lower Limit
- 0.6
- spread
- 0.6
- upper Limit
- 42.9
- value
- 11.1
- group Id
- OG002
- lower Limit
- 0.6
- spread
- 0.6
- upper Limit
- 42.9
- value
- 11.1
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 9
- group Id
- OG002
- value
- 9
- units
- Participants
- description
- ORR was defined as the percentage of participants achieving best overall response (BOR) of confirmed partial response (PR) or complete response (CR) determined by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as disappearance of all target and non-target lesions. All pathological (whether target or non-target) must have a reduction in their short axis less than (\<) 10 millimeter (mm). PR was at least a 30 percent (%) decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 90% Confidence Interval
- groups
- description
- Participants with RMS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of intolerable toxicity or withdrawal of consent.
- id
- OG000
- title
- Phase 2: RMS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- description
- Participants with NRSTS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
- id
- OG001
- title
- Phase 2: NRSTS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- description
- Participants with EWS received eribulin mesilate 1.4 mg/m\^2, intravenous infusion on Days 1 and 8 and Irinotecan hydrochloride 40 mg/m\^2, intravenous infusion on Days 1 to 5 in every 21 days treatment cycle until disease progression, development of unacceptable toxicity or withdrawal of consent.
- id
- OG002
- title
- Phase 2: EWS Cohort, Eribulin Mesilate 1.4 mg/m^2 + Irinotecan 40 mg/m^2
- param Type
- NUMBER
- population Description
- Full analysis set included all participants who received at least 1 dose of either study drug.
- reporting Status
- POSTED
- time Frame
- From date of first dose of study drug until disease progression, development of unacceptable toxicity, withdrawal of consent, or up to approximately 2 years 4 months
- title
- Phase 2: Objective Response Rate (ORR)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice