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NCT02514447 · ClinicalTrials.gov registry record · Phase 1
Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy
A Phase 1 study, sponsored by G1 Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 123
- Enrollment target
NCT02514447 is a Phase 1 study that has completed, run by G1 Therapeutics. The registered enrollment target is 123 participants.
The verdict
NCT02514447, a Phase 1 study, has completed, sponsored by G1 Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 123 participants
- Enrollment target
Study Summary
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prior to topotecan in patients previously treated for extensive-stage SCLC. The study consisted of 2 parts: a limited open-label, dose-finding portion (Part 1), and a randomized double-blind portion (Part 2). Both parts included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase began on the day of first dose with study treatment and completes at the Post-Treatment Visit.
Interventions
- DRUG Placebo
- DRUG Topotecan
- DRUG Trilaciclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 123 participants |
| Start Date | 2015-10-05 |
| Est. Completion | 2021-10-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02514447
The ClinicalTrials.gov registry entry for NCT02514447 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 123 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 Placebo is the first listed.
NCT02514447 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02514447 about?
NCT02514447 is a clinical study titled "Trilaciclib (G1T28) in Patients With Previously Treated Extensive Stage SCLC Receiving Topotecan Chemotherapy". This was a study to investigate the potential clinical benefit of trilaciclib (G1T28), a Cyclin Dependent Kinase (CDK) 4/6 inhibitor, in preserving the bone marrow and the immune system, in order to decrease chemotherapy-induced myelosuppression and improve anti-tumor efficacy when administered prio...
What is the current status of trial NCT02514447?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 123 participants. The study started on 2015-10-05. Estimated completion is 2021-10-04.
What interventions are being tested in trial NCT02514447?
The interventions under investigation include: Placebo (DRUG), Topotecan (DRUG), Trilaciclib (DRUG).
Who is sponsoring clinical trial NCT02514447?
This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
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