TriangleNCT04145349 · OUTCOME
Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
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
- 80% Confidence Interval
- Time frame
- Randomization until measured progressive disease (Up To 23 Months)
What was measured
* The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma. * CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to \<10 mm. Tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference.
Analysis population: All randomized participants who received at least one dose of study drug.
Groups in this outcome
Ramucirumab + Cyclophosphamide + Vinorelbine
Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
Cyclophosphamide + Vinorelbine
Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
| Group | Source count |
|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine | 20 |
| Cyclophosphamide + Vinorelbine | 10 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Ramucirumab + Cyclophosphamide + Vinorelbine | 10 | Not reported | 2.7 | 24.5 | Not reported |
| Cyclophosphamide + Vinorelbine | 10 | Not reported | 1.1 | 33.7 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.7
- upper Limit
- 24.5
- value
- 10
- group Id
- OG001
- lower Limit
- 1.1
- upper Limit
- 33.7
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 10
- units
- Participants
- description
- * The ORR was defined as the percentage of participants achieving either a CR or PR. Tumor response was assessed based on histology: Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) was used for solid tumors, and Response Assessment in Neuro-Oncology criteria were used for glioblastoma. * CR was defined as the disappearance of all target lesions, with any pathological lymph nodes (whether target or non-target) showing a reduction in the short axis to \<10 mm. Tumor marker results were required to have normalized. PR was defined as a decrease of at least 30% in the sum of the diameters of target lesions, using baseline diameters as the reference.
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Ramucirumab administered intravenously at a dose of 12 mg/kg as a one-hour infusion on days 1 and 15. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
- id
- OG000
- title
- Ramucirumab + Cyclophosphamide + Vinorelbine
- description
- Participants received the following treatments in a 28-day cycle, continuing until disease progression or a criterion for discontinuation was met. * Cyclophosphamide administered orally at 25 mg/m² daily from days 1 to 28. * Vinorelbine administered intravenously at 25 mg/m² on days 1, 8, and 15.
- id
- OG001
- title
- Cyclophosphamide + Vinorelbine
- param Type
- NUMBER
- population Description
- All randomized participants who received at least one dose of study drug.
- reporting Status
- POSTED
- time Frame
- Randomization until measured progressive disease (Up To 23 Months)
- title
- Overall Response Rate (ORR): Percentage of Participants Who Achieved a Complete Response (CR) or Partial Response (PR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice