RecruitingEndometrial Cancer
RESOLVE: Abemaciclib + Letrozole +/- Metformin or Gedatolisib in Endometrial Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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)
Sponsor: Dana-Farber Cancer Institute
You may qualify if…
- ✓ 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, 6 and 7, must have histologically confirmed either i) endometrioid endometrial cancer or ii) endometrial carcinosarcoma with endometrioid epithelial component
- ✓ Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If multiple analyses have been performed, judgment should be based on the most recent biopsy or pathology specimen analyzed in a CLIA-certified laboratory.
- ✓ Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam.
- ✓ Age ≥ 18 years
- ✓ ECOG performance status of 0 or 1
- ✓ Participants must have normal organ and bone marrow function as defined below:
- ✓ Absolute neutrophil count ≥ 1,500/mcL
- ✓ Platelets ≥ 100,000/mcL
You may not qualify if…
- ✕ Participants who have had chemotherapy, immune therapy, other investigational therapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of study medication. Previous hormonal therapy, including prior letrozole, is allowed and there is no required washout period for hormonal therapy.
- ✕ Participants who have had tyrosine kinase inhibitor (TKI) therapy within 5 half-lives of study entry.
- ✕ Participants who have had radiation therapy within 2 weeks of the first dose of study medication.
- ✕ Participants who have received previous treatment with CDK4/6 inhibitors, including but not limited to previous abemaciclib therapy. For Cohort 7, patients must have received prior treatment with CDK4/6 inhibitors.
- ✕ Participants who are currently receiving metformin therapy (if enrolling to Cohort 3).
- ✕ Participants who have impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs
- ✕ Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
- ✕ History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents that the participant will be administered.
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT03675893 · last updated 2026-06-22