TriangleNCT02669914 · OUTCOME
Duration of Response Considering Both Intracranial and Extracranial Disease
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Completion of treatment (estimated to be 6 months)
What was measured
* Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause * Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline * Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
Analysis population: Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. The remaining two participants were not evaluable for this outcome measure because they didn't have an objective response. There were not any participants enrolled in Cohort B or Cohort C.
Groups in this outcome
Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
-MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
| Group | Source count |
|---|---|
| Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids | 0 |
| Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids | 0 |
| Cohort C: NSCLC or Non-NSCLC w/Corticosteroids | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- description
- * Defined as the interval from the first documentation of objective response (complete response or partial response) to the earlier of the first documentation of disease progression or death from any cause * Intracranial disease: response and progression will be evaluated using the updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology (RANO) working group guideline * Extracranial disease: response and progression will be evaluated using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)
- groups
- description
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- id
- OG000
- title
- Cohort A: Non-small Cell Lung Cancer w/o Corticosteroids
- description
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- id
- OG001
- title
- Cohort B: Epithelial Origin Solid Tumors w/o Corticosteroids
- description
- -MEDI4736 will be given to all patients \> 30 kg actual body weight intravenously at a fixed dose 750 mg every 2 weeks over the course of 60 minutes on an outpatient basis on Days 1 and 15 of each 28-day cycle. Patients \< 30 kg actual body weight will be dosed at 10 mg/kg every 2 weeks.
- id
- OG002
- title
- Cohort C: NSCLC or Non-NSCLC w/Corticosteroids
- population Description
- Two participants were not evaluable in Cohort A as the extracranial response per RECIST was not done. The remaining two participants were not evaluable for this outcome measure because they didn't have an objective response. There were not any participants enrolled in Cohort B or Cohort C.
- reporting Status
- POSTED
- time Frame
- Completion of treatment (estimated to be 6 months)
- title
- Duration of Response Considering Both Intracranial and Extracranial Disease
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice