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Cyclin-Dependent Kinase Inhibitor

Letrozole 2.5mg by mouth once a day (QD) + Lerociclib 150mg by mouth twice a day (BID) for Endometrial Cancer

Phase 3

Waitlist Available

Research Sponsored by EQRx International, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 27 months

Awards & highlights

Study Summary

This trial will compare a combination of lerociclib & letrozole to placebo & letrozole in female participants with low-grade endometrial cancer to assess safety & efficacy.

Eligible Conditions

Endometrial Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 27 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS)

Secondary outcome measures

Overall Survival (OS)

Patient Reported Outcomes/Quality of Life

Progression Free Survival (PFS) by Investigator

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Letrozole 2.5mg by mouth once a day (QD) + Lerociclib 150mg by mouth twice a day (BID)Experimental Treatment2 Interventions

Group II: Letrozole 2.5mg by mouth once a day (QD) + PlaceboPlacebo Group2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Letrozole 2.5mg

2019

Completed Phase 4

~840

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Find a Location

Who is running the clinical trial?

EQRx International, Inc.Lead Sponsor

3 Previous Clinical Trials

20 Total Patients Enrolled

GOG FoundationNETWORK

42 Previous Clinical Trials

16,741 Total Patients Enrolled

4 Trials studying Endometrial Cancer

1,498 Patients Enrolled for Endometrial Cancer

European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER

36 Previous Clinical Trials

17,239 Total Patients Enrolled

4 Trials studying Endometrial Cancer

866 Patients Enrolled for Endometrial Cancer

Media Library

Lerociclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05712941 — Phase 3

Endometrial Cancer Research Study Groups: Letrozole 2.5mg by mouth once a day (QD) + Lerociclib 150mg by mouth twice a day (BID), Letrozole 2.5mg by mouth once a day (QD) + Placebo

Endometrial Cancer Clinical Trial 2023: Lerociclib Highlights & Side Effects. Trial Name: NCT05712941 — Phase 3

Lerociclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05712941 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project currently open for enrollment?

"Yes, according to clinicaltrials.gov's records this trial is actively recruiting and was initially posted on April 18th 2023 with a recent update occurring on April 21st of the same year. 320 individuals are required across 1 site for the study."

Answered by AI

How many participants are being welcomed into this experiment?

"Indeed, clinicaltrials.gov reflects that this medical experiment is currently recruiting individuals. It was first published on April 18th 2023 and has recently been updated on the 21st of April 2023. The trial requires 320 participants to be sourced from a single facility."

Answered by AI

Has the FDA granted authorization for Letrozole 2.5mg orally daily plus Lerociclib 150mg orally twice a day?

"The safety of Letrozole 2.5mg QD + Lerociclib 150mg BID is regarded as a 3 based on the available clinical evidence, which has shown efficacy and multiple rounds supporting its security profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer

2023. "Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05712941.