Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
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ClinicalTrials.gov Identifier: NCT02978716 |
Recruitment Status :
Terminated
(Primary Analysis and survival follow up completed per protocol. Not stopped due to safety concerns)
First Posted : December 1, 2016
Results First Posted : March 23, 2022
Last Update Posted : March 23, 2022
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Sponsor:
G1 Therapeutics, Inc.
Information provided by (Responsible Party):
G1 Therapeutics, Inc.
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Triple-Negative Breast Neoplasms Breast Neoplasm Breast Cancer Triple-Negative Breast Cancer |
Interventions |
Drug: Trilaciclib Drug: Gemcitabine Drug: Carboplatin |
Enrollment | 102 |
Participant Flow
Recruitment Details | This study was conducted at 34 sites in the United States (US), Belgium, Bulgaria, Croatia, Republic of Macedonia, and Serbia from 02 February 2017 (first participant enrolled) to 28 February 2020 (last participant last visit). |
Pre-assignment Details | Participants were screened within 28 days before the first dose of the treatment. Informed consent was obtained up to 28 days prior to first study drug administration. For tumor assessment, all sites of disease were assessed radiologically at screening. A total of 102 participants were randomized in this study. |
Arm/Group Title | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) |
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Participants received Intravenous (IV) infusion of standard GC chemotherapy (gemcitabine 1000 milligrams per meter square [mg/m^2] and carboplatin area under the curve [AUC] 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. |
Period Title: Overall Study | |||
Started | 34 | 33 | 35 |
ITT Population [1] | 34 | 33 | 35 |
Safety Analysis Set [2] | 30 | 33 | 35 |
Treated | 30 | 33 | 35 |
Completed | 0 | 0 | 0 |
Not Completed | 34 | 33 | 35 |
Reason Not Completed | |||
Death | 25 | 13 | 20 |
Lost to Follow-up | 0 | 0 | 1 |
Withdrawal by Subject | 6 | 4 | 5 |
Sponsor terminated | 2 | 13 | 9 |
Other | 1 | 3 | 0 |
[1]
The Intent-to-Treat (ITT) analysis set included all randomized participants.
[2]
The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
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Baseline Characteristics
Arm/Group Title | Group 1: Gemcitabine/Carboplatin (Days 1 and 8) | Group 2: Trilaciclib + Gemcitabine/Carboplatin (Days 1 and 8) | Group 3: Trilaciclib (Days 1, 2, 8 and 9) + Gemcitabine/Carboplatin (Days 2 and 9) | Total | |
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Participants received IV infusion of standard GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) on Days 1 and 8 of 21-day cycles. The carboplatin dose was calculated using the Calvert formula, with a target AUC 2 (maximum 300 mg). | Participants received IV infusion of trilaciclib 240 mg/m^2 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Days 1 and 8 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | Participants received IV infusion of trilaciclib 240 mg/m^2 on Days 1, 2, 8, and 9 plus GC chemotherapy (gemcitabine 1000 mg/m^2 and carboplatin AUC 2) IV infusion on Day 2 and 9 of 21-day cycles. Trilaciclib was administered prior to chemotherapy. | Total of all reporting groups | |
Overall Number of Baseline Participants | 34 | 33 | 35 | 102 | |
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The ITT analysis set included all randomized participants.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 34 participants | 33 participants | 35 participants | 102 participants | |
55 (13.6) | 56 (12.1) | 58 (9.5) | 56 (11.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 34 participants | 33 participants | 35 participants | 102 participants | |
Female |
34 100.0%
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32 97.0%
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35 100.0%
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101 99.0%
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Male |
0 0.0%
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1 3.0%
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0 0.0%
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1 1.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 34 participants | 33 participants | 35 participants | 102 participants | |
Hispanic or Latino |
2 5.9%
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5 15.2%
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2 5.7%
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9 8.8%
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Not Hispanic or Latino |
32 94.1%
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28 84.8%
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33 94.3%
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93 91.2%
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Unknown or Not Reported |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 34 participants | 33 participants | 35 participants | 102 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
0 0.0%
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2 6.1%
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4 11.4%
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6 5.9%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
5 14.7%
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7 21.2%
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2 5.7%
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14 13.7%
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White |
28 82.4%
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22 66.7%
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28 80.0%
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78 76.5%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
1 2.9%
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2 6.1%
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1 2.9%
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4 3.9%
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Outcome Measures
Adverse Events
Limitations and Caveats
Limitations of this study are the small sample size and open-label design. Antitumor outcomes were not the primary endpoints.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The investigator will submit results communications for review by the sponsor at least 60 days prior to expected submission to the intended publisher or meeting committee. This review period may be shortened upon mutual consent. The sponsor may request modification of any publication, presentation or use by the investigator if such activity may jeopardize a patent application, an existing patent, or other proprietary rights.
Results Point of Contact
Name/Title: | Clinical Trial Info |
Organization: | G1 Therapeutics, Inc |
Phone: | +1 9192139835 |
EMail: | clinicalinfo@g1therapeutics.com |
Publications:
Responsible Party: | G1 Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02978716 |
Other Study ID Numbers: |
G1T28-04 2016-004466-26 ( EudraCT Number ) |
First Submitted: | November 18, 2016 |
First Posted: | December 1, 2016 |
Results First Submitted: | January 6, 2022 |
Results First Posted: | March 23, 2022 |
Last Update Posted: | March 23, 2022 |