TriangleNCT03245151 · OUTCOME
Phase 1: Clinical Benefit Rate (CBR)
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
CBR was defined as percentage of participants who had BOR of CR, PR, or durable SD (SD duration \>=23 weeks since the first dose of study treatment) divided by number of participants in analysis set. CBR 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 | 22.2 | 6.4 | 6.4 | 47.6 | 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
- 6.4
- spread
- 6.4
- upper Limit
- 47.6
- value
- 22.2
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 18
- units
- Participants
- description
- CBR was defined as percentage of participants who had BOR of CR, PR, or durable SD (SD duration \>=23 weeks since the first dose of study treatment) divided by number of participants in analysis set. CBR 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: Clinical Benefit Rate (CBR)
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice