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Cyclin-Dependent Kinase Inhibitor
Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 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
Pivotal Trial
Summary
This trial is testing a combination of two drugs, lerociclib and letrozole, in postmenopausal women with advanced or recurrent low-grade endometrial cancer. The goal is to see if this combination is more effective than letrozole alone. Lerociclib helps stop cancer cells from growing, while letrozole lowers estrogen levels to slow cancer growth.
Eligible Conditions
- Uterine 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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression Free Survival (PFS)
Secondary study objectives
Overall Survival (OS)
Patient Reported Outcomes/Quality of Life
Progression Free Survival (PFS) by Investigator
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
~1490
Find a Location
Who is running the clinical trial?
EQRx International, Inc.Lead Sponsor
3 Previous Clinical Trials
20 Total Patients Enrolled
GOG FoundationNETWORK
46 Previous Clinical Trials
17,650 Total Patients Enrolled
European Network of Gynaecological Oncological Trial Groups (ENGOT)OTHER
39 Previous Clinical Trials
18,206 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Letrozole 2.5mg by mouth once a day (QD) + Lerociclib 150mg by mouth twice a day (BID)
- Group 2: Letrozole 2.5mg by mouth once a day (QD) + Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.