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NCT02978716 · ClinicalTrials.gov registry record · Phase 2
Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
A Phase 2 study, sponsored by G1 Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 102
- Enrollment target
NCT02978716 is a Phase 2 study that was terminated before completion, run by G1 Therapeutics. The registered enrollment target is 102 participants.
The verdict
NCT02978716, a Phase 2 study, was terminated before completion, sponsored by G1 Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 102 participants
- Enrollment target
Study 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.
Interventions
- DRUG Carboplatin
- DRUG Gemcitabine
- DRUG Trilaciclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2017-02-02 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02978716
The ClinicalTrials.gov registry entry for NCT02978716 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is G1 Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Carboplatin is the first listed.
NCT02978716 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02978716 about?
NCT02978716 is a clinical study titled "Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)". 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 negativ...
What is the current status of trial NCT02978716?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 102 participants. The study started on 2017-02-02. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT02978716?
The interventions under investigation include: Carboplatin (DRUG), Gemcitabine (DRUG), Trilaciclib (DRUG).
Who is sponsoring clinical trial NCT02978716?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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