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NCT02514447 · OUTCOME

Pharmacokinetic Profile for Topotecan When Administered With Trilaciclib (G1T28)

Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy · Source last updated 2025-09-25

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 topotecan when administered with trilaciclib (G1T28)

Analysis population: All patients who had evaluable PK profiles for both treatments and analytes.

Groups in this outcome

Trilaciclib (G1T28) + Topotecan 0.75 mg/m²- 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) + Topotecan 1 mg/m²- 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) + Topotecan 1.25 mg/m²- 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) + Topotecan 1.50 mg/m²- 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 (1.50 mg/m²).

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Trilaciclib (G1T28) + Topotecan 0.75 mg/m²- Part 119
Trilaciclib (G1T28) + Topotecan 1 mg/m²- Part 17
Trilaciclib (G1T28) + Topotecan 1.25 mg/m²- Part 13
Trilaciclib (G1T28) + Topotecan 1.50 mg/m²- Part 12
Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b25
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a27
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b29

Reported measurements

Source class 1
Values in ng/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Trilaciclib (G1T28) + Topotecan 0.75 mg/m²- Part 121.134.6Not reportedNot reportedNot reported
Trilaciclib (G1T28) + Topotecan 1 mg/m²- Part 136.841.8Not reportedNot reportedNot reported
Trilaciclib (G1T28) + Topotecan 1.25 mg/m²- Part 152.466.5Not reportedNot reportedNot reported
Trilaciclib (G1T28) + Topotecan 1.50 mg/m²- Part 1NANANot reportedNot reportedThere 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.
Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b43.039.0Not reportedNot reportedNot reported
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a17.536.5Not reportedNot reportedNot reported
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.5 mg/m² - Part 2b41.446.9Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        34.6
        value
        21.1
      2. group Id
        OG001
        spread
        41.8
        value
        36.8
      3. group Id
        OG002
        spread
        66.5
        value
        52.4
      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.
        group Id
        OG003
        spread
        NA
        value
        NA
      5. group Id
        OG004
        spread
        39.0
        value
        43.0
      6. group Id
        OG005
        spread
        36.5
        value
        17.5
      7. group Id
        OG006
        spread
        46.9
        value
        41.4
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      2
    5. group Id
      OG004
      value
      25
    6. group Id
      OG005
      value
      27
    7. group Id
      OG006
      value
      29
    units
    Participants
description
Maximum concentration (Cmax) of topotecan when administered with trilaciclib (G1T28)
dispersion Type
Geometric Coefficient of Variation
groups
  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
    OG000
    title
    Trilaciclib (G1T28) + Topotecan 0.75 mg/m²- Part 1
  2. 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) + Topotecan 1 mg/m²- Part 1
  3. 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) + Topotecan 1.25 mg/m²- Part 1
  4. 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 (1.50 mg/m²).
    id
    OG003
    title
    Trilaciclib (G1T28) + Topotecan 1.50 mg/m²- Part 1
  5. 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
    OG004
    title
    Placebo + Topotecan 1.5 mg/m² - Parts 2a and 2b
  6. 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
    OG005
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m² - Part 2a
  7. 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
    OG006
    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 Topotecan When Administered With Trilaciclib (G1T28)
type
SECONDARY
unit Of Measure
ng/ml

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice