At a glance
ClinicalIndex Comparison Record- ✓Recurrent or metastatic endometrial cancer resistant to standard therapies or no standard therapy available
- ✓Endometrioid endometrial cancer or endometrial carcinosarcoma with endometrioid epithelial component (Cohorts 1A stage 2, 3, 4, 6, 7)
- ✓Low-grade serous carcinoma of ovary, fallopian tube or peritoneum (Cohort 5)
- ✓ER-positive disease (≥1% tumor cell nuclei immunoreactive by IHC), except Cohort 5
- ✕Chemotherapy, immune therapy, investigational therapy, or major surgery within 4 weeks (6 weeks for nitrosoureas/mitomycin C)
- ✕Tyrosine kinase inhibitor therapy within 5 half-lives
- ✕Radiation therapy within 2 weeks
- ✕Previous CDK4/6 inhibitor treatment (except Cohorts 4, 5 up to 50%, Cohort 7 required)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
RESOLVE: A Multi-Cohort Phase 2 Study of Letrozole/Abemaciclib Alone and in Combination With Metformin and Gedatolisib
In Brief
A Phase 2 clinical trial evaluating Letrozole, Abemaciclib, and 3 other interventions for Endometrial Cancer. Currently recruiting, targeting 110 participants across 3 sites.
Detailed Summary
This research study is studying a combination of targeted therapies as a possible treatment for estrogen-receptor positive (ER+) endometrial cancer. The drugs involved in this study are: * Abemaciclib (also known as Verzenio™) * Letrozole (also known as Femara®) * Metformin (also known as Glucophage®) * Gedatolisib (also known as PF-05212384)
Study Details
Timeline
Arms & Interventions
* Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily * Letrozole is administered by mouth once daily
* Abemaciclib is administered by mouth twice daily * LY3023414 is administered by mouth twice daily
* Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily
* Abemaciclib is administered by mouth twice daily * Letrozole is administered by mouth once daily * Metformin is administered by mouth once daily
* 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
* 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
Interventions
Letrozole is a hormonal therapy that works by lowering the production of estrogen in the body.
Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.
LY3023414 is a potent selective inhibitor of the class I PI3K isoforms, mTOR, and DNA-PK.
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 is a PI3K/AKT/mTOR (PAM) pathway inhibitor.