TriangleNCT02514447 · OUTCOME
Overall Survival (OS)
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
- From date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2220 days).
What was measured
Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive.
Analysis population: The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
Groups in this outcome
Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
| Group | Source count |
|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 29 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 30 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 32 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | 2 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 3 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 4 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 8 |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 7 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 8 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 6.5 | Not reported | 3.5 | 11.3 | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 5.8 | Not reported | 4.1 | 8.1 | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 6.2 | Not reported | 4.0 | 9.9 | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | NA | Not reported | NA | NA | Due to zero events, the median and its confidence limits could not be estimated. |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 10.6 | Not reported | 8.3 | 25.3 | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 8.3 | Not reported | 4.5 | 11.8 | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 9.4 | Not reported | 1.1 | 12.5 | Not reported |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 4.4 | Not reported | 2.1 | 10.0 | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 10.0 | Not reported | 2.1 | NA | The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.5
- upper Limit
- 11.3
- value
- 6.5
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- 8.1
- value
- 5.8
- group Id
- OG002
- lower Limit
- 4.0
- upper Limit
- 9.9
- value
- 6.2
- comment
- Due to zero events, the median and its confidence limits could not be estimated.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG004
- lower Limit
- 8.3
- upper Limit
- 25.3
- value
- 10.6
- group Id
- OG005
- lower Limit
- 4.5
- upper Limit
- 11.8
- value
- 8.3
- group Id
- OG006
- lower Limit
- 1.1
- upper Limit
- 12.5
- value
- 9.4
- group Id
- OG007
- lower Limit
- 2.1
- upper Limit
- 10.0
- value
- 4.4
- comment
- The upper confidence limit for the median was not estimable, as the upper confidence limits for the survivor function lies above 0.5.
- group Id
- OG008
- lower Limit
- 2.1
- upper Limit
- NA
- value
- 10.0
- denoms
- counts
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 30
- group Id
- OG002
- value
- 32
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 8
- group Id
- OG007
- value
- 7
- group Id
- OG008
- value
- 8
- units
- Participants
- description
- Median time (months) and 95% CI from date of first dose date of study drug/randomization until date of death. Patients who do not die during the study will be censored at the date last known to be alive.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients in Parts 2a and 2b were randomized 1:2 to placebo. Patients received placebo administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Placebos Topotecan
- id
- OG000
- title
- Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
- description
- Patients in Part 2a were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²). Trilaciclib Topotecan
- id
- OG001
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
- description
- Patients in Part 2b were randomized 2:1 to trilaciclib. Patients received trilaciclib (240 mg/m²) administered IV once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²). Trilaciclib Topotecan
- id
- OG002
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
- description
- Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).
- id
- OG003
- title
- Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1
- description
- Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.25 mg/m²).
- id
- OG004
- title
- Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1
- description
- Patients received trilaciclib (200 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
- id
- OG005
- title
- Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1
- description
- Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
- id
- OG006
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1
- description
- Patients received trilaciclib (280 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).
- id
- OG007
- title
- Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1
- description
- Patients received trilaciclib (240 mg/m²) administered intravenously (IV) once daily on Days 1 to 5 of each 21-day topotecan chemotherapy cycle. Following administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.0 mg/m²).
- id
- OG008
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1
- param Type
- MEDIAN
- population Description
- The intent-to-treat (ITT) analysis set: All enrolled patients who received at least one dose of study drugs in Part 1 and all randomized patients in Part 2 on the basis of the assigned treatment.
- reporting Status
- POSTED
- time Frame
- From date of first dose of study drug (Part 1)/randomization (Part 2) until the date of death due to any cause (evaluated up to a maximum of 2220 days).
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice