{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"34.6","value":"21.1"},{"groupId":"OG001","spread":"41.8","value":"36.8"},{"groupId":"OG002","spread":"66.5","value":"52.4"},{"comment":"There was an insufficient number of participants with evaluable PK profiles to calculate the Cmax geometric mean or median for the Part 1 Topotecan 1.5 mg/m2 cohort.","groupId":"OG003","spread":"NA","value":"NA"},{"groupId":"OG004","spread":"39.0","value":"43.0"},{"groupId":"OG005","spread":"36.5","value":"17.5"},{"groupId":"OG006","spread":"46.9","value":"41.4"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"19"},{"groupId":"OG001","value":"7"},{"groupId":"OG002","value":"3"},{"groupId":"OG003","value":"2"},{"groupId":"OG004","value":"25"},{"groupId":"OG005","value":"27"},{"groupId":"OG006","value":"29"}],"units":"Participants"}],"description":"Maximum concentration (Cmax) of topotecan when administered with trilaciclib (G1T28)","dispersionType":"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.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG000","title":"Trilaciclib (G1T28) + Topotecan 0.75 mg/m²- 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.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG001","title":"Trilaciclib (G1T28) + Topotecan 1 mg/m²- 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.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75, 1.0, 1.25, or 1.50 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG002","title":"Trilaciclib (G1T28) + Topotecan 1.25 mg/m²- 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.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.50 mg/m²).","id":"OG003","title":"Trilaciclib (G1T28) + Topotecan 1.50 mg/m²- 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.\n\nFollowing administration of placebo on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).\n\nPlacebos\n\nTopotecan","id":"OG004","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.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (0.75 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG005","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.\n\nFollowing administration of trilaciclib on Days 1 to 5, patients received IV topotecan (1.5 mg/m²).\n\nTrilaciclib\n\nTopotecan","id":"OG006","title":"Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b"}],"paramType":"GEOMETRIC_MEAN","populationDescription":"All patients who had evaluable PK profiles for both treatments and analytes.","reportingStatus":"POSTED","timeFrame":"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 Topotecan When Administered With Trilaciclib (G1T28)","type":"SECONDARY","unitOfMeasure":"ng/ml"}