TriangleNCT02514447 · OUTCOME
Chemotherapy Cycles and Modifications Overall
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- cycles
- Interval / dispersion
- Standard Deviation
- Time frame
- During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to a maximum of 1335 days).
What was measured
Average exposure and cycle modifications in chemotherapy (topotecan)
Analysis population: Safety analysis set: All enrolled patients who received at least 1 dose of study drug.
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 | 28 |
| 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
Number of cycles completed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 4 | 3.4 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 5 | 5.4 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 5 | 4.4 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | 6 | 0.0 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 7 | 5.0 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 4 | 1.7 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 6 | 2.9 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 4 | 3.4 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 4 | 2.2 | Not reported | Not reported | Not reported |
Number of cycles delayed
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 1 | 1.2 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 2 | 2.5 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 1 | 1.4 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m² - Cohort 1- Part 1 | 3 | 1.4 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m² - Cohort 2- Part 1 | 1 | 1.2 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m² - Cohort 3- Part 1 | 1 | 0.5 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Cohorts 4 and 6- Part 1 | 1 | 0.8 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m² - Cohort 5- Part 1 | 0 | 0.5 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m² - Cohort 7- Part 1 | 1 | 1.0 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.4
- value
- 4
- group Id
- OG001
- spread
- 5.4
- value
- 5
- group Id
- OG002
- spread
- 4.4
- value
- 5
- group Id
- OG003
- spread
- 0.0
- value
- 6
- group Id
- OG004
- spread
- 5.0
- value
- 7
- group Id
- OG005
- spread
- 1.7
- value
- 4
- group Id
- OG006
- spread
- 2.9
- value
- 6
- group Id
- OG007
- spread
- 3.4
- value
- 4
- group Id
- OG008
- spread
- 2.2
- value
- 4
- title
- Number of cycles completed
- categories
- measurements
- group Id
- OG000
- spread
- 1.2
- value
- 1
- group Id
- OG001
- spread
- 2.5
- value
- 2
- group Id
- OG002
- spread
- 1.4
- value
- 1
- group Id
- OG003
- spread
- 1.4
- value
- 3
- group Id
- OG004
- spread
- 1.2
- value
- 1
- group Id
- OG005
- spread
- 0.5
- value
- 1
- group Id
- OG006
- spread
- 0.8
- value
- 1
- group Id
- OG007
- spread
- 0.5
- value
- 0
- group Id
- OG008
- spread
- 1.0
- value
- 1
- title
- Number of cycles delayed
- denoms
- counts
- group Id
- OG000
- value
- 28
- 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
- Average exposure and cycle modifications in chemotherapy (topotecan)
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- Safety analysis set: All enrolled patients who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- During the treatment period. From date of first dose, 21 day treatment cycles continue until disease progression, unacceptable toxicity, or discontinuation by the patient or investigator (assessed up to a maximum of 1335 days).
- title
- Chemotherapy Cycles and Modifications Overall
- type
- SECONDARY
- unit Of Measure
- cycles
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice