TriangleNCT04238819 · OUTCOME
Duration of Response (DoR): Part C
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Date of first evidence of a CR, PR, or MR to date of objective disease progression or death due to any cause (Up to 25 Months)
What was measured
DoR is the time between first evidence of CR, PR or MR and disease progression or death due to any cause. CR, PR, and MR was as per International Neuroblastoma Response Criteria (INRC). \- CR is defined as complete response in all response components: Primary Tumor: \<10 mm residual soft tissue primary site and complete resolution of MIBG-avid tumors Soft tissue and bone metastatic response: nonprimary target and nontarget lesions \<10 mm and nodes identified as targets decreased to short axis \<10mm and MIBG-avid update of nonprimary lesions completely resolved Bone marrow response: no tumor infiltration on reassessment; disappearance of all target lesions; * PR is defined as PR in \>1 component and all other components are either CR, minimal disease (MD) (bone marrow only), PR (soft tissue or bone), or not involved (NI) and no components with progressive disease (PD). * MR is defined PR or CR in \>1 component and SD in \>1 component and no component with PD
Analysis population: All participants in Part C who received at least one dose of the study drug and had evaluable data for this outcome.
Groups in this outcome
Part C Cohort C1
Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. * Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle. * Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
| Group | Source count |
|---|---|
| Part C Cohort C1 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part C Cohort C1 | 1.61 | Not reported | NA | NA | Only 1 participant had events, hence confidence interval limits could not be calculated. |
Complete source fields
- classes
- categories
- measurements
- comment
- Only 1 participant had events, hence confidence interval limits could not be calculated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 1.61
- denoms
- counts
- group Id
- OG000
- value
- 1
- units
- Participants
- description
- DoR is the time between first evidence of CR, PR or MR and disease progression or death due to any cause. CR, PR, and MR was as per International Neuroblastoma Response Criteria (INRC). \- CR is defined as complete response in all response components: Primary Tumor: \<10 mm residual soft tissue primary site and complete resolution of MIBG-avid tumors Soft tissue and bone metastatic response: nonprimary target and nontarget lesions \<10 mm and nodes identified as targets decreased to short axis \<10mm and MIBG-avid update of nonprimary lesions completely resolved Bone marrow response: no tumor infiltration on reassessment; disappearance of all target lesions; * PR is defined as PR in \>1 component and all other components are either CR, minimal disease (MD) (bone marrow only), PR (soft tissue or bone), or not involved (NI) and no components with progressive disease (PD). * MR is defined PR or CR in \>1 component and SD in \>1 component and no component with PD
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * Temozolomide: 100 mg/m²/day, administered orally on Days 1-5 of each cycle. * Dinutuximab: 17.5mg/m²/day, administered IV on Days 2-5 of each cycle. * Granulocyte-macrophage colony-stimulating factor (GM-CSF): 250 μg/m²/day, administered subcutaneously (SC) on Days 6-12 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
- id
- OG000
- title
- Part C Cohort C1
- param Type
- MEDIAN
- population Description
- All participants in Part C who received at least one dose of the study drug and had evaluable data for this outcome.
- reporting Status
- POSTED
- time Frame
- Date of first evidence of a CR, PR, or MR to date of objective disease progression or death due to any cause (Up to 25 Months)
- title
- Duration of Response (DoR): Part C
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice