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Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)

NCT02978716 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-03-23

Study results available
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Summary

This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for participants with metastatic triple negative breast cancer.

The study was an open-label and 102 participants were randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups:

* Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=34)
* Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=33)
* Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=35)

The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.

Conditions

  • Triple-Negative Breast Neoplasms
  • Breast Neoplasm
  • Breast Cancer
  • Triple-Negative Breast Cancer

Interventions

DRUG

Trilaciclib

G1T28

DRUG

Gemcitabine

Gemcitabine

DRUG

Carboplatin

Carboplatin

Sponsors & Collaborators

  • G1 Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Contact · G1 Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-02
Primary Completion
2019-06-28
Completion
2020-02-28
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Croatia
  • North Macedonia
  • Serbia
  • Slovakia
  • Slovenia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02978716 on ClinicalTrials.gov