Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Abemaciclib · 1 trial · 1 indication
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 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. |
| 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, ...
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Abemaciclib is an investigational small molecule being studied for the treatment of endometrial cancer. It is currently in Phase 2 clinical development. The drug is being evaluated in combination with letrozole, with or without metformin or gedatolisib, in patients with endometrial cancer.
Abemaciclib targets cyclin-dependent kinases (CDKs), as indicated by its '-ciclib' drug class. By inhibiting CDKs, it interferes with cell cycle progression, which is a key mechanism in cancer cell proliferation. This targeting is being explored in the context of endometrial cancer treatment.
Abemaciclib is being developed by Celcuity Inc., a biopharmaceutical company. The company's stock ticker is CELC. Celcuity is conducting clinical trials to evaluate the drug's safety and efficacy in endometrial cancer.
Abemaciclib is in Phase 2 clinical development for endometrial cancer. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to further assess its potential as a treatment.
Abemaciclib is being studied in the RESOLVE trial (NCT03675893), a Phase 2 study in endometrial cancer. This trial is recruiting 110 female patients aged 18 years and older in the United States. It evaluates abemaciclib plus letrozole, with or without metformin or gedatolisib.
Abemaciclib belongs to the '-ciclib' class of CDK inhibitors, which includes other drugs targeting cyclin-dependent kinases. However, it is a distinct compound with its own chemical structure and development program. It is being studied specifically for endometrial cancer in combination with other agents.