Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02514447 · OUTCOME

Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1) to the end of Cycle 1, each cycle = 21 days)

What was measured

The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Absolute neutrophil count (ANC) \< 0.5 × 10\^9/L lasting for ≥ 7 days * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding * Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\^9/L and platelet count ≥ 100 × 10\^9/L; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT * ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \> 72 hours)

Analysis population: The safety analysis set: All enrolled patients who received at least 1 dose of study drug.

Groups in this outcome

Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m²- Part 1 Cohort 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) 200 mg/m² + Topotecan 1.25 mg/m²- Part 1 Cohort 2

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) 200 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 3

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 0.75 mg/m²- Part 1 Cohorts 4 and 6

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 0.75 mg/m²- Part 1 Cohort 5

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 1.0 mg/m²- Part 1 Cohort 7

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

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) 200 mg/m² + Topotecan 1.5 mg/m²- Part 1 Cohort 12
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m²- Part 1 Cohort 23
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 34
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohorts 4 and 68
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 57
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m²- Part 1 Cohort 78

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.5 mg/m²- Part 1 Cohort 12Not reportedNot reportedNot reportedNot reported
Trilaciclib (G1T28) 200 mg/m² + Topotecan 1.25 mg/m²- Part 1 Cohort 22Not reportedNot reportedNot reportedNot reported
Trilaciclib (G1T28) 200 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 32Not reportedNot reportedNot reportedNot reported
Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohorts 4 and 60Not reportedNot reportedNot reportedNot reported
Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 52Not reportedNot reportedNot reportedNot reported
Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m²- Part 1 Cohort 72Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        2
      6. group Id
        OG005
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      2
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      8
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      8
    units
    Participants
description
The percentage of patients experiencing DLTs in Part 1 of the study in each cohort, including: * Absolute neutrophil count (ANC) \< 0.5 × 10\^9/L lasting for ≥ 7 days * ≥ Grade 3 neutropenic infection/febrile neutropenia * Grade 4 thrombocytopenia or ≥ Grade 3 thrombocytopenia with bleeding * Unable to start next cycle of chemotherapy due to lack of recovery to an ANC ≥ 1.5 × 10\^9/L and platelet count ≥ 100 × 10\^9/L; a delay of up to 1 week from the scheduled start of Cycle 2 is allowed for recovery of ANC and platelet count, and is not considered a DLT * ≥ Grade 3 nonhematologic toxicity (nausea, vomiting, and diarrhea failing maximal medical management; fatigue lasting for \> 72 hours)
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) 200 mg/m² + Topotecan 1.5 mg/m²- Part 1 Cohort 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) 200 mg/m² + Topotecan 1.25 mg/m²- Part 1 Cohort 2
  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) 200 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 3
  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 (0.75, 1.0, 1.25, or 1.50 mg/m²). Trilaciclib Topotecan
    id
    OG003
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohorts 4 and 6
  5. 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
    OG004
    title
    Trilaciclib (G1T28) 280 mg/m² + Topotecan 0.75 mg/m²- Part 1 Cohort 5
  6. 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
    OG005
    title
    Trilaciclib (G1T28) 240 mg/m² + Topotecan 1.0 mg/m²- Part 1 Cohort 7
param Type
COUNT_OF_PARTICIPANTS
population Description
The safety analysis set: All enrolled patients who received at least 1 dose of study drug.
reporting Status
POSTED
time Frame
Evaluated for Cycle 1 (i.e., from date of first dose of study drug (Part 1) to the end of Cycle 1, each cycle = 21 days)
title
Assess the Dose Limiting Toxicities (DLTs) of G1T28/Trilaciclib Administered With Topotecan in Part 1
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice