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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: Completed Phase 1 study, sponsored by G1 Therapeutics.
NCT02514447 is a Phase 1 study that has completed, run by G1 Therapeutics. The registered enrollment target is 123 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (105% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Duration of severe neutropenia (DSN; days) was defined as the number of days from the date of the first ANC value of \<0.5 × 10\^9/L observed between start of cycle and end of cycle to the date of the first ANC value ≥0.5 × 10\^9/L that met the following criteria: (1) occurred after the ANC value of \<0.5 × 10\^9/L and (2) no other ANC values \<0.5 × 10\^9/L occurred between this day and end of cycle. DSN is set to 0 for patients who did not experience SN in a cycle, including those who were ran
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 |
What the finished NCT02514447 record still lists
NCT02514447 is an interventional study that assigns participants to a tested intervention. The registered 123 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (105% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02514447 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02514447's enrollment target sits among peer trials
123 475th of 2000 higher than 1,526 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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