TriangleNCT03245151 · OUTCOME
Phase 1: Disease Control Rate (DCR)
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
- From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months)
What was measured
DCR was defined as percentage of participants with a confirmed CR, PR, or stable disease (SD) (SD duration \>=7 weeks since the first dose of study treatment) divided by number of participants in analysis set. DCR was assessed by an investigator based on RECIST v1.1 for non-HGG participants or RANO for HGG participants. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Analysis population: SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
Groups in this outcome
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2
Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2
Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
| Group | Source count |
|---|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 5 |
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 18 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2 | 20.0 | 0.5 | 0.5 | 71.6 | Not reported |
| Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2 | 50.0 | 26.0 | 26.0 | 74.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.5
- spread
- 0.5
- upper Limit
- 71.6
- value
- 20.0
- group Id
- OG001
- lower Limit
- 26.0
- spread
- 26.0
- upper Limit
- 74.0
- value
- 50.0
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- DCR was defined as percentage of participants with a confirmed CR, PR, or stable disease (SD) (SD duration \>=7 weeks since the first dose of study treatment) divided by number of participants in analysis set. DCR was assessed by an investigator based on RECIST v1.1 for non-HGG participants or RANO for HGG participants. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
- id
- OG000
- title
- Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2
- description
- Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
- id
- OG001
- title
- Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2
- param Type
- NUMBER
- population Description
- SAS included all participants who received at least 1 dose of study drug (lenvatinib or everolimus).
- reporting Status
- POSTED
- time Frame
- From first dose of study drug until PD or death, whichever occurred first (up to 16.5 months)
- title
- Phase 1: Disease Control Rate (DCR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice