TriangleNCT02514447 · OUTCOME
Pharmacokinetic Profile for Trilaciclib (G1T28) When Administered With Topotecan
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ng/ml
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Part 1 of the study during Cycle 1 Day 4 : predose, 0.5, 1, 1.5, 2, 2.5, 3, 4.5, 6.5, 8.5 (optional), and 24.5 hours post dose. Part 2 of the study during Cycle 1 Day 4 : predose, 0.5, 1, between 3 to 4 hours and between 5.5 to 6.5 hours post dose.
What was measured
Maximum concentration (Cmax) of trilaciclib (G1T28) when administered with topotecan
Analysis population: All patients who had evaluable PK profiles for both treatments and analytes.
Groups in this outcome
Trilaciclib (G1T28) 200 mg/m² + Topotecan - Part 1
Patients received trilaciclib (200, 240, or 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, 1.0, 1.25, or 1.50 mg/m²). Trilaciclib Topotecan
Trilaciclib (G1T28) 240 mg/m² + Topotecan - Part 1
Patients received trilaciclib (200, 240, or 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, 1.0, 1.25, or 1.50 mg/m²). Trilaciclib Topotecan
Trilaciclib (G1T28) 280 mg/m² + Topotecan - Part 1
Patients received trilaciclib (200, 240, or 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, 1.0, 1.25, or 1.50 mg/m²). Trilaciclib Topotecan
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
| Group | Source count |
|---|---|
| Trilaciclib (G1T28) 200 mg/m² + Topotecan - Part 1 | 9 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan - Part 1 | 15 |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan - Part 1 | 7 |
| Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b | 0 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 28 |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 30 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trilaciclib (G1T28) 200 mg/m² + Topotecan - Part 1 | 1060 | 59.0 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan - Part 1 | 1220 | 120 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 280 mg/m² + Topotecan - Part 1 | 2220 | 75.2 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a | 913 | 59.6 | Not reported | Not reported | Not reported |
| Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b | 1100 | 54.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 59.0
- value
- 1060
- group Id
- OG001
- spread
- 120
- value
- 1220
- group Id
- OG002
- spread
- 75.2
- value
- 2220
- group Id
- OG004
- spread
- 59.6
- value
- 913
- group Id
- OG005
- spread
- 54.8
- value
- 1100
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 15
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 28
- group Id
- OG005
- value
- 30
- units
- Participants
- description
- Maximum concentration (Cmax) of trilaciclib (G1T28) when administered with topotecan
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Patients received trilaciclib (200, 240, or 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, 1.0, 1.25, or 1.50 mg/m²). Trilaciclib Topotecan
- id
- OG000
- title
- Trilaciclib (G1T28) 200 mg/m² + Topotecan - Part 1
- description
- Patients received trilaciclib (200, 240, or 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, 1.0, 1.25, or 1.50 mg/m²). Trilaciclib Topotecan
- id
- OG001
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan - Part 1
- description
- Patients received trilaciclib (200, 240, or 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, 1.0, 1.25, or 1.50 mg/m²). Trilaciclib Topotecan
- id
- OG002
- title
- Trilaciclib (G1T28) 280 mg/m² + Topotecan - Part 1
- 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
- OG003
- 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
- OG004
- 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
- OG005
- title
- Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b
- param Type
- GEOMETRIC_MEAN
- population Description
- All patients who had evaluable PK profiles for both treatments and analytes.
- reporting Status
- POSTED
- time Frame
- Part 1 of the study during Cycle 1 Day 4 : predose, 0.5, 1, 1.5, 2, 2.5, 3, 4.5, 6.5, 8.5 (optional), and 24.5 hours post dose. Part 2 of the study during Cycle 1 Day 4 : predose, 0.5, 1, between 3 to 4 hours and between 5.5 to 6.5 hours post dose.
- title
- Pharmacokinetic Profile for Trilaciclib (G1T28) When Administered With Topotecan
- type
- SECONDARY
- unit Of Measure
- ng/ml
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice