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

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 18, 2023

Primary Completion Date

March 31, 2024

Study Completion Date

March 31, 2025

Conditions
Endometrial Carcinoma
Interventions
DRUG

Lerociclib

"All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted.~Participants will be randomized to receive either lerociclib (administered at 150 mg twice a day (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD).~Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata:~* Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent)~* EC tumor grade (Grade 1 versus Grade 2)~* Geographic location (US versus Europe versus Rest of World)"

DRUG

Letrozole 2.5mg

"All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted.~Participants will be randomized to receive either lerociclib (administered at 150 mg twice daily (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD).~Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata:~* Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent)~* EC tumor grade (Grade 1 versus Grade 2)~* Geographic location (US versus Europe versus Rest of World)"

DRUG

Placebo

"All participants should be treated according to the best-current-practice guidelines and standard of care within each institution or country where the study is conducted.~Participants will be randomized to receive either lerociclib (administered at 150 mg twice day (BID) in combination with letrozole (administered at 2.5 mg once a day (QD), or placebo administered in combination with letrozole (2.5 mg QD).~Participants will also be stratified, using interactive response technology (IRT), by the following randomization strata:~* Endometrial Cancer (EC) tumor staging (Federation Internationale de Gynecologie et d'Obstetrique \[FIGO\] Stage III versus FIGO Stage IV versus recurrent)~* EC tumor grade (Grade 1 versus Grade 2)~* Geographic location (US versus Europe versus Rest of World)"

Sponsors
All Listed Sponsors
collaborator

GOG Foundation

NETWORK

collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

lead

EQRx International, Inc.

INDUSTRY