TriangleNCT01742286 · OUTCOME
Summary of Best Overall Response by Overall Response Rate (ORR) Per Investigator 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
- 30 months
What was measured
ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). ORR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma \& other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
Analysis population: Full Analysis Set (FAS)/Maximum Tolerated Dose MTD)/Recommended dose for expansion (RDE): Results are presented only for patients who received at least 1 dose of ceritinib in either of the 2 MTD/RDE groups and were based on combining data from across the dose-escalation \& dose-expansion phases, \& summarized according to primary diagnosis of tumor.
Groups in this outcome
ALK-activated Neuroblastoma
Participants with ALK-activated neuroblastoma enrolled in the expansion part of the study and were given ceritinib once daily, continuously
ALK-activated Inflammatory Myofibroblastic Tumors (IMT)
Participants with ALK-activated IMT enrolled in the expansion part of the study who were given ceritinib once daily, continuously
ALK-activated Anaplastic Large Cell Lymphoma (ALCL)
Participants with ALK-activated ALCL enrolled in the expansion part of the study who were given ceritinib once daily, continuously
ALK-activated Other
Participants with other ALK-activated tumors enrolled in the expansion part of the study who were given ceritinib once daily, continuously
| Group | Source count |
|---|---|
| ALK-activated Neuroblastoma | 30 |
| ALK-activated Inflammatory Myofibroblastic Tumors (IMT) | 10 |
| ALK-activated Anaplastic Large Cell Lymphoma (ALCL) | 8 |
| ALK-activated Other | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| ALK-activated Neuroblastoma | 20.0 | Not reported | 7.7 | 38.6 | Not reported |
| ALK-activated Inflammatory Myofibroblastic Tumors (IMT) | 70.0 | Not reported | 34.8 | 93.3 | Not reported |
| ALK-activated Anaplastic Large Cell Lymphoma (ALCL) | 75.0 | Not reported | 34.9 | 96.8 | Not reported |
| ALK-activated Other | 14.3 | Not reported | 0.4 | 57.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.7
- upper Limit
- 38.6
- value
- 20.0
- group Id
- OG001
- lower Limit
- 34.8
- upper Limit
- 93.3
- value
- 70.0
- group Id
- OG002
- lower Limit
- 34.9
- upper Limit
- 96.8
- value
- 75.0
- group Id
- OG003
- lower Limit
- 0.4
- upper Limit
- 57.9
- value
- 14.3
- denoms
- counts
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 7
- units
- Participants
- description
- ORR is the percentage of participants with a best overall response of complete response (CR) or partial response (PR). ORR was assessed per Investigator as per RECIST 1.1 in participants with neuroblastoma and other solid tumors, and by International Working Group (IWG) criteria in patients with lymphoma. Per RECIST 1.1 (for neuroblastoma \& other solid tumors): CR: disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \< 10 mm. PR: at least a 30% decrease in the sum of diameter of all target lesion, taking as reference the baseline sum diameters. Per IWG criteria (for patients with lymphoma): CR: normalization of all index nodal lesions or complete disappearance of all index extranodal lesions. PR: at least 50% decrease from baseline in the sum of diameters of all index lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with ALK-activated neuroblastoma enrolled in the expansion part of the study and were given ceritinib once daily, continuously
- id
- OG000
- title
- ALK-activated Neuroblastoma
- description
- Participants with ALK-activated IMT enrolled in the expansion part of the study who were given ceritinib once daily, continuously
- id
- OG001
- title
- ALK-activated Inflammatory Myofibroblastic Tumors (IMT)
- description
- Participants with ALK-activated ALCL enrolled in the expansion part of the study who were given ceritinib once daily, continuously
- id
- OG002
- title
- ALK-activated Anaplastic Large Cell Lymphoma (ALCL)
- description
- Participants with other ALK-activated tumors enrolled in the expansion part of the study who were given ceritinib once daily, continuously
- id
- OG003
- title
- ALK-activated Other
- param Type
- NUMBER
- population Description
- Full Analysis Set (FAS)/Maximum Tolerated Dose MTD)/Recommended dose for expansion (RDE): Results are presented only for patients who received at least 1 dose of ceritinib in either of the 2 MTD/RDE groups and were based on combining data from across the dose-escalation \& dose-expansion phases, \& summarized according to primary diagnosis of tumor.
- reporting Status
- POSTED
- time Frame
- 30 months
- title
- Summary of Best Overall Response by Overall Response Rate (ORR) Per Investigator Assessment
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice