ALEPRO: abemaciclib and letrozole in estrogen receptor positive rare ovarian cancer

Conditions

Adult-type granulosa cell tumor, Low-grade serous ovarian cancer

Brief summary

To determine the overall response rate (ORR) of the combination of abemaciclib and letrozole in the study population, as defined by RECIST v1.1.

Detailed description

Efficacy endpoints: duration of response (DOR), clinical benefit ratio (CBR), progression free survival (PFS), overall survival (OS), Safety endpoints, including but not limited to TEAEs, SAEs, hospitalizations, clinical laboratory tests, vital signs, and physical examinations, To evaluate participant-reported symptoms, function and global health status/QOL based on EORTC QLQ-C30 scales, To evaluate health status in the study population to inform decision modeling for health economic evaluation using the EQ-5D 5L index score, Exploratory endpoints: investigate potential biomarkers related to cyclin pathway and/or the pathogenesis of low-grade serous/endometrioid ovarian cancer and granulosa cell tumors.

Ottenbourgs T, van Gorp T, Kridelka F, Baert T, Denys H, Selle F, Baas I, Van Rompuy AS, Lambrechts D, Van Nieuwenhuysen E.

2024-04-019 citations

10.1136/ijgc-2023-005189

Interventions

DRUGLETROZOLE

DRUGABEMACICLIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
To determine the overall response rate (ORR) of the combination of abemaciclib and letrozole in the study population, as defined by RECIST v1.1.	—

Secondary

Measure	Time frame
Efficacy endpoints: duration of response (DOR), clinical benefit ratio (CBR), progression free survival (PFS), overall survival (OS), Safety endpoints, including but not limited to TEAEs, SAEs, hospitalizations, clinical laboratory tests, vital signs, and physical examinations, To evaluate participant-reported symptoms, function and global health status/QOL based on EORTC QLQ-C30 scales, To evaluate health status in the study population to inform decision modeling for health economic evaluation using the EQ-5D 5L index score, Exploratory endpoints: investigate potential biomarkers related to cyclin pathway and/or the pathogenesis of low-grade serous/endometrioid ovarian cancer and granulosa cell tumors.	—

Measure

Time frame

Efficacy endpoints: duration of response (DOR), clinical benefit ratio (CBR), progression free survival (PFS), overall survival (OS), Safety endpoints, including but not limited to TEAEs, SAEs, hospitalizations, clinical laboratory tests, vital signs, and physical examinations, To evaluate participant-reported symptoms, function and global health status/QOL based on EORTC QLQ-C30 scales, To evaluate health status in the study population to inform decision modeling for health economic evaluation using the EQ-5D 5L index score, Exploratory endpoints: investigate potential biomarkers related to cyclin pathway and/or the pathogenesis of low-grade serous/endometrioid ovarian cancer and granulosa cell tumors.

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Countries

Belgium, France, Netherlands

Outcome results

None listed