TriangleNCT04154189 · OUTCOME
Percentage of Participants With PFS at 1 Year or Month 12 (PFS-1y Rate) by IIR Assessment
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
- Month 12 or 1 Year
What was measured
PFS-1y rate as assessed by IIR was defined as the percentage of participants who were alive and without PD at 1 year from randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS-1y rate was estimated using Kaplan-Meier method.
Analysis population: FAS included all randomized participants regardless of the treatment actually received.
Groups in this outcome
Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
Treatment Arm B: Ifosfamide + Etoposide
Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
| Group | Source count |
|---|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | 40 |
| Treatment Arm B: Ifosfamide + Etoposide | 41 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide | NA | Not reported | NA | NA | Number and 95% confidence interval data could not be estimated because all participants had an event or were censored before Month 12. |
| Treatment Arm B: Ifosfamide + Etoposide | 14.9 | Not reported | 1.1 | 44.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- comment
- Number and 95% confidence interval data could not be estimated because all participants had an event or were censored before Month 12.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 44.5
- value
- 14.9
- denoms
- counts
- group Id
- OG000
- value
- 40
- group Id
- OG001
- value
- 41
- units
- Participants
- description
- PFS-1y rate as assessed by IIR was defined as the percentage of participants who were alive and without PD at 1 year from randomization date using RECIST v1.1. PD was defined as at least a 20% increase or 5 mm increase in the sum of diameters of target lesions (taking as reference the smallest sum on study) recorded since the treatment started or the appearance of 1 or more new lesions. PFS-1y rate was estimated using Kaplan-Meier method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received lenvatinib 14 mg/m\^2, capsules, orally, once daily, plus ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously. Ifosfamide and etoposide were administered on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Lenvatinib was administered in continuous 21-day cycles. Treatment continued until PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first.
- id
- OG000
- title
- Treatment Arm A: Lenvatinib + Ifosfamide + Etoposide
- description
- Participants received ifosfamide 3000 mg/m\^2/day, intravenously and etoposide 100 mg/m\^2/day, intravenously on Days 1 to 3 of each 21-day cycle for up to 5 cycles. Participants who had PD per RECIST v1.1 were eligible for an optional lenvatinib treatment (14 mg/m\^2, capsules, orally, once daily in continuous 21-day cycles until next PD, development of unacceptable toxicity, participant choice, withdrawal of consent or discontinuation of study by the sponsor, whichever occurred first) plus any remaining cycles of chemotherapy if 5 cycles were not completed prior to PD.
- id
- OG001
- title
- Treatment Arm B: Ifosfamide + Etoposide
- param Type
- NUMBER
- population Description
- FAS included all randomized participants regardless of the treatment actually received.
- reporting Status
- POSTED
- time Frame
- Month 12 or 1 Year
- title
- Percentage of Participants With PFS at 1 Year or Month 12 (PFS-1y Rate) by IIR Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice