Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03675893 | RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer | PHASE2 | RECRUITING | 180 | — | — | Dec 24, 2018 | Aug 1, 2031 | Jun 15, 2025 | 3 | United States |
Number of patients alive and disease progression-free per RECIST 1.1 criteria.
Number of patients who experience objective tumor responses per RECIST 1.1 criteria.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily * Letrozole is administered by mouth once daily |
| Cohort 2 | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily |
| Cohort 1A | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily |
| Cohort 3 | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Metformin is administered by mouth once daily |
| Cohort 4 | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Zotatifin is administered intravenously on days 1 and 8 of a 21-day cycle |
| Cohort 5 | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Zotatifin is administered intravenously on days 1 and 8 of a 21-day cycle |
| Cohort 6 | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Gedatolisib is administered intravenously on days 1, 8 and 15 of a 28-day cycle |
| Cohort 7 | EXPERIMENTAL | * Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Gedatolisib is administered intravenously on days 1, 8 and 15 of a 28-day cycle |
| Name | Type | Description |
|---|---|---|
| Letrozole | DRUG | Letrozole is a hormonal therapy that works by lowering the production of estrogen in the body. |
| Abemaciclib | DRUG | Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. |
| LY3023414 | DRUG | LY3023414 is a potent selective inhibitor of the class I PI3K isoforms, mTOR, and DNA-PK. |
| Metformin | DRUG | Metformin inhibits mitochondrial adenosine-5'-triphosphate (ATP) synthesis, resulting in activation of the AMPK (5' AMP-activated protein kinase) pathway through LKB1, eventually causing inhibition of the mTOR pathway and subsequent reduction in protein synthesis and cellular proliferation. |
| Zotatifin | DRUG | Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor. |
| Gedatolisib | DRUG | Gedatolisib is a PI3K/AKT/mTOR (PAM) pathway inhibitor. |
Inclusion Criteria: * Participants must have cytologically or histologically confirmed endometrial cancer that is recurrent or metastatic and/or resistant to standard therapies, or for which no standard therapy is available.Participants enrolled in the second stage of Cohort 1A, or into Cohort 3, 4...