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NCT04887831 · ClinicalTrials.gov registry record · Phase 2

Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab

A Phase 2 study, sponsored by G1 Therapeutics.

Terminated
Registry status
Phase 2
Development phase
92
Enrollment target

NCT04887831: Clinical Trial Phase 2 study, sponsored by G1 Therapeutics.

NCT04887831 is a Phase 2 study that was terminated before completion, run by G1 Therapeutics. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04887831, a Phase 2 study, was terminated before completion, sponsored by G1 Therapeutics.

TERMINATED
Registry status
Phase 2
Development phase
92 participants
Enrollment target

Study Summary

This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenance therapy in participants receiving first-line treatment for advanced/metastatic urothelial carcinoma.

Primary Outcome

The PFS was defined as the time from date of randomization to the date of the first documented disease progression, or death in the absence of PD for those who had a PFS event, and the time from randomization to the censoring date for those who did not have a PFS event.

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Gemcitabine
  • DRUG Avelumab
  • DRUG Trilaciclib

Trial Details

FieldValue
Enrollment Target 92 participants
Start Date 2021-06-04
Est. Completion 2024-03-01
Phase Phase 2
G1 Therapeutics

12 total trials

Why NCT04887831 stopped before completion

NCT04887831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).

The record links to 0 conditions, and to 5 interventions - of which Carboplatin is the first listed.

NCT04887831 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04887831 about?

NCT04887831 is a clinical study titled "Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelumab". This is a Phase 2, multicenter, randomized, open-label study evaluating the safety and efficacy of trilaciclib administered with platinum-based chemotherapy followed by trilaciclib administered with avelumab maintenance therapy compared with platinum-based chemotherapy followed by avelumab maintenan...

What is the current status of trial NCT04887831?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2021-06-04. Estimated completion is 2024-03-01.

What interventions are being tested in trial NCT04887831?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Gemcitabine (DRUG), Avelumab (DRUG), Trilaciclib (DRUG).

Who is sponsoring clinical trial NCT04887831?

This trial is sponsored by G1 Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04887831's enrollment target sits among peer trials

92 767th of 2000 higher than 1,230 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT04887831, the US trial registry maintained by the National Library of Medicine. NCT04887831 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.