Comparison of Letrozole With Lerociclib Versus Letrozole With Placebo Control in Patients With Advanced/Metastatic or Recurrent, Grade 1 or Grade 2 Endometrial Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: EQRx International, Inc.
Stay on Your Current Meds
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
Eligibility Criteria
Inclusion Criteria
Naïve to prior endocrine therapy for EC
Adequate organ function
Able to swallow oral medications or receive them by PEG tube
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Exclusion Criteria
Received radiation therapy within 21 days prior to study entry
Tumor histology with non-endometrioid component of ≥ 5%
Loss of Rb on genetic testing of tumor tissue
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Treatment Details
Interventions
- Lerociclib (Cyclin-Dependent Kinase Inhibitor)
- Letrozole (Aromatase Inhibitor)
- Placebo (Other)
Participant Groups
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Trials 365 LLCShreveport, LA
Center Of Hope, RenoReno, NV
FirstHealth of the CarolinasPinehurst, NC
Miami Valley Hospital SouthCenterville, OH
More Trial Locations
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Who Is Running the Clinical Trial?
EQRx International, Inc.
Lead Sponsor
Trials
4
Patients Recruited
20+
GOG Foundation
Collaborator
Trials
48
Patients Recruited
18,500+
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Collaborator
Trials
41
Patients Recruited
19,200+