TriangleNCT02514447 · OUTCOME
Duration of Response (DOR)
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 occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, (assessed up to a maximum of 1335 days).
What was measured
The median months and 95% CIs of duration of response.
Analysis population: Response-Evaluable analysis set: All patients who are in the mITT, have measurable disease (target lesions) at the baseline tumor assessment, and either (i) have at least 1 post-baseline tumor assessment, (ii) have clinical progression as noted by the investigator before their first post-baseline tumor scan, or (iii) have died due to disease progression before their first post-baseline tumor scan.
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 | 6 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 3 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 5 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | 1 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 2 |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 0 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 1 |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 0 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 4.9 | Not reported | 2.1 | NA | The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5. |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 7.8 | Not reported | 4.1 | NA | The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5. |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 6.8 | Not reported | 2.8 | NA | The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5. |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | NA | Not reported | NA | NA | Due to an insufficient number of participants with events, zero or only 1 event, the confidence limits for the median could not be estimated. |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 5.4 | Not reported | 3.1 | 7.7 | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 6.7 | Not reported | NA | NA | The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5. |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | NA | Not reported | NA | NA | Due to an insufficient number of participants with events, zero or only 1 event, the confidence limits for the median could not be estimated. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5.
- group Id
- OG000
- lower Limit
- 2.1
- upper Limit
- NA
- value
- 4.9
- comment
- The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5.
- group Id
- OG001
- lower Limit
- 4.1
- upper Limit
- NA
- value
- 7.8
- comment
- The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5.
- group Id
- OG002
- lower Limit
- 2.8
- upper Limit
- NA
- value
- 6.8
- comment
- Due to an insufficient number of participants with events, zero or only 1 event, the confidence limits for the median could not be estimated.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- group Id
- OG004
- lower Limit
- 3.1
- upper Limit
- 7.7
- value
- 5.4
- comment
- The upper confidence limit for the median was not estimable, due to an insufficient number of participants with events, as the upper confidence limits for the survivor function lies above 0.5.
- group Id
- OG006
- lower Limit
- NA
- upper Limit
- NA
- value
- 6.7
- comment
- Due to an insufficient number of participants with events, zero or only 1 event, the confidence limits for the median could not be estimated.
- group Id
- OG008
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 2
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 1
- units
- Participants
- description
- The median months and 95% CIs of duration of response.
- 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
- Response-Evaluable analysis set: All patients who are in the mITT, have measurable disease (target lesions) at the baseline tumor assessment, and either (i) have at least 1 post-baseline tumor assessment, (ii) have clinical progression as noted by the investigator before their first post-baseline tumor scan, or (iii) have died due to disease progression before their first post-baseline tumor scan.
- reporting Status
- POSTED
- time Frame
- From date of first dose of study drug (Part 1)/randomization (Part 2) until the occurrence of progressive disease, withdrawal of consent, or initiation of subsequent anti-cancer therapy, (assessed up to a maximum of 1335 days).
- title
- Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice