Actively Recruiting
RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer
Led by Dana-Farber Cancer Institute · Updated on 2025-06-15
180
Participants Needed
3
Research Sites
657 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying a combination of targeted therapies as a possible treatment for estrogen-receptor positive (ER+) endometrial cancer and low-grade serous ovarian cancer. The drugs involved in this study are: * Abemaciclib (also known as Verzenio™) * Letrozole (also known as Femara®) * Metformin (also known as Glucophage®) * Zotatifin (also known as eFT226) * Gedatolisib (also known as PF-05212384)
CONDITIONS
Official Title
RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have cytologically or histologically confirmed recurrent or metastatic endometrial cancer or low-grade serous carcinoma of ovary, fallopian tube, or peritoneum, with specific histologic subtypes required for certain cohorts
- Participants must have estrogen receptor (ER) positive disease, except for Cohort 5 where ER status does not apply
- Participants must have measurable disease with at least one lesion meeting size requirements
- Participants must be 18 years or older
- ECOG performance status of 0 or 1
- Normal organ and bone marrow function as defined by specific blood count and chemistry criteria
- For certain cohorts, participants must have no remaining ovarian function or be on hormonal suppression
- Women of childbearing potential must use approved contraceptive methods during treatment and for 3 months after
- Ability to understand and sign informed consent
- Ability to swallow and retain oral medication
- Participants may have received unlimited prior therapies
- Archival tissue available for analysis
- Specific metabolic and genetic criteria for certain cohorts including HbA1c and fasting glucose levels, TP53 status, and prior CDK4/6 inhibitor therapy for Cohort 7
You will not qualify if you...
- Receipt of chemotherapy, immune therapy, other investigational therapy, or major surgery within 4 weeks prior to study entry (6 weeks for certain drugs)
- Receipt of tyrosine kinase inhibitors within 5 half-lives prior to study entry
- Radiation therapy within 2 weeks prior to study entry
- Prior treatment with CDK4/6 inhibitors except allowed for some cohorts with limits
- Current metformin therapy if enrolling to Cohort 3
- Gastrointestinal conditions affecting drug absorption
- Known brain metastases
- Allergic reactions to similar compounds
- Need for medications that strongly interact with study drugs
- Uncontrolled illnesses including infections, heart conditions, psychiatric illness, or social issues limiting compliance
- Use of QT-prolonging drugs or cardiovascular risk factors including recent acute coronary syndromes
- Pregnancy or breastfeeding
- History of other malignancies unless disease-free for 5 years or low-risk exceptions
- Known HIV infection
- Uncontrolled hypertension
- For certain cohorts, inability to determine QT interval or abnormal QT interval on ECG
- For certain cohorts, type 1 diabetes or uncontrolled type 2 diabetes
- Prior treatment with PI3K pathway inhibitors except limited prior mTOR inhibitor use in some cohorts
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02214
Actively Recruiting
2
Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
P
Panagiotis Konstantinopoulos, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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