2026-06-18
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v13
Enrollment target180→110
Study arms8→6
InterventionsAbemaciclib (Drug), Gedatolisib (Drug), LY3023414 (Drug), Letrozole (Drug), Metformin (Drug), Zotatifin (Drug)→Abemaciclib (Drug), Gedatolisib (Drug), LY3023414 (Drug), Letrozole (Drug), Metformin (Drug)
Eligibility criteria-750 characters
[...] enrolled in the second stage of Cohort 1A, or into Cohort 3, 4, 6 and 7, must have histologically confirmed either i) endo [...] trial carcinosarcoma with endometrioid epithelial component
For Cohort 5: Participants must have histologically confirmed diagnosis of low-grade serous carcinoma of ovary, fallopian tube or peritoneum; original diagnosis of de novo low-grade serous carcinoma or original diagnosis of serous borderline tumor with subsequent diagnosis of low-grade serous carcin [...] Participants must have ER-positive disease, defined as ≥ 1 p [...] pathology specimen analyzed in a CLIA-certified laborator [...]
Study description-263 characters
[...] es but is considered investigational for its use in cancer.
The FDA has not approved zotatifin as a treatment for any disease.
The FDA has not approved gedatolisib as a treatment for any [...] s to stop cancer cell growth and promote cancer cell death.
Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor.
Selective eIF4A inhibition works by stopping cancer cell growth and enhancing CDK inhibition.
Gedatolisib is a PI3K/AKT/mTOR (PAM) pathway inhibitor.
PAM [...] ations of abemaciclib and letrozole alone, or with metformin, zotatifin or gedatolisib are effective at slowing or stopping [...] [...]
Study sitescontacts updated at 1 of 3 sites
Collaborators3 to 2 entries
Effector Therapeutics
Study title-40 characters
RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer
2025-06-12
notable
Active, Not Recruiting→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v12
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2027-08-01→2028-08-01
Completion date2030-08-01→2031-08-01
Enrollment target130→180
Study arms6→8
InterventionsAbemaciclib (Drug), LY3023414 (Drug), Letrozole (Drug), Metformin (Drug), Zotatifin (Drug)→Abemaciclib (Drug), Gedatolisib (Drug), LY3023414 (Drug), Letrozole (Drug), Metformin (Drug), Zotatifin (Drug)
Eligibility criteria+1,453 characters
[...] nrolled in the second stage of Cohort 1A, or into Cohort 3, 4, 6 and 7, must have histologically confirmed either i) endometrioid en [...] creatinine levels above institutional normal.
For cohorts 4, 5, 6 and 57, patients must not have remaining ovarian function to be in [...] nt document.
Ability to swallow and retain oral medication.
Participants can have received an unlimited number of prior therapies.
Participants must have archival tissue available for analysi [...] t need to be received by the study team prior to enrollment
For Cohorts 6 and 7, participants must have HbA1c ≤6.4% and fasting plasma glucose ( [...] [...]
Study description+295 characters
[...] has not approved zotatifin as a treatment for any disease.
The FDA has not approved gedatolisib as a treatment for any disease.
Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.
CD [...] y stopping cancer cell growth and enhancing CDK inhibition.
Gedatolisib is a PI3K/AKT/mTOR (PAM) pathway inhibitor.
PAM inhibitors work to stop cancer cell growth.
PAM inhibition has been shown to enhance CDK inhibitors and hormonal therapy, like abemaciclib and letrozole.
In this research study, we are hoping to learn whether the combinationcombinations of abemaciclib and letrozole alone, or with metformin, [...] [...]
Study sitesdetails revised at 3 of 3 sites
Collaborators2 to 3 entries
Celcuity Inc
Study title+14 characters
RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or ZotatifinGedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer
2024-11-05
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Oversight, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-08-01→2027-08-01
Completion date2029-08-01→2030-08-01
Study sitesdetails revised at 3 of 3 sites
2024-06-10
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility v10
Primary completion date2024-05-01→2026-08-01
Completion date2026-05-01→2029-08-01
Enrollment target60→130
Study arms4→6
InterventionsAbemaciclib (Drug), LY3023414 (Drug), Letrozole (Drug), Metformin (Drug)→Abemaciclib (Drug), LY3023414 (Drug), Letrozole (Drug), Metformin (Drug), Zotatifin (Drug)
Eligibility criteria+918 characters
[...] trial carcinosarcoma with endometrioid epithelial component
For Cohort 5: Participants must have histologically confirmed diagnosis of low-grade serous carcinoma of ovary, fallopian tube or peritoneum; original diagnosis of de novo low-grade serous carcinoma or original diagnosis of serous borderline tumor with subsequent diagnosis of low-grade serous carcin [...] Participants must have ER-positive disease, defined as ≥ 1 p [...] pathology specimen analyzed in a CLIA-certified laboratory.
For Cohort 5, participants are eligible regardless of ER positive or negative status.
Participants must have measurable [...] [...]
Study description+281 characters
[...] es but is considered investigational for its use in cancer.
The FDA has not approved zotatifin as a treatment for any disease.
Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.
CD [...] s to stop cancer cell growth and promote cancer cell death.
Zotatifin is a selective eukaryotic initiation factor 4A (eIF4A) inhibitor.
Selective eIF4A inhibition works by stopping cancer cell growth and enhancing CDK inhibition.
In this research study, we are hoping to learn whether the combination of abemaciclib, letrozole, and letrozole alone, with metformin, or with zotatifin is effective at slowing or sto [...] [...]
Collaborators1 to 2 entries
Effector Therapeutics
Study title+26 characters
RESOLVE: Abemaciclib + Letrozole +/- Metformin or Zotatifin in RecurrentEndometrial or PersistentLow-Grade EndometrialSerous Ovarian Cancer
Show 8 earlier versions
2023-03-21
minor
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility v8
Primary completion date2023-05-01→2024-05-01
Completion date2025-05-01→2026-05-01
Enrollment target40→60
Study arms1→4
InterventionsAbemaciclib (Drug), Letrozole (Drug)→Abemaciclib (Drug), LY3023414 (Drug), Letrozole (Drug), Metformin (Drug)
Eligibility criteria+311 characters
[...] rd therapies, or for which no standard therapy is available.Participants enrolled in the second stage of Cohort 1A, or into Cohort 3, 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 [...] bilirubin ≤ 1.5 × institutional upper limit of normal (ULN).
Patients with Gilbert's syndrome with a total bilirubin </= 2.0 times ULN and direct bilirubin within normal limits are permitted.
AST(SGOT)/ALT(SGPT) ≤ 2.5 3× institutional ULN, OR
5 × instituti [...] [...]
Study description+374 characters
[...] nvestigational" means that the drugs are being studied.
The U.S. Food and Drug Administration (FDA) has not approved abemaciclib or letrozole for ER+your endometrialspecific cancer,disease but bothit drugs havehas been approved for other uses.
The FDA has approved metformin for diabetes but is considered investigational for its use in cancer.
Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.
CD [...] herapy that works by lowering the production of estrogen in theyour body.
Estrogen may help to stimulate cancer cells to grow, so lowering the levels of estrogen in theyour body may work to slow [...] [...]
Study title+11 characters
Abemaciclib With+ Letrozole +/- Metformin in Recurrent or Persistent Endometrial Cancer
2022-05-23
minor
Study Status v7
Primary completion date2022-05-01→2023-05-01
Completion date2024-05-01→2025-05-01
2021-06-23
minor
Study Status v6
Primary completion date2021-05-01→2022-05-01
2021-02-22
minor
Study Status v5
Re-verified, no change to tracked fields
2020-01-30
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 1 of 3 sites
2019-08-02
minor
Study Identification, Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v3
Primary completion date2020-06-01→2021-05-01
Completion date2020-12-01→2024-05-01
Enrollment target62→40
Study arms2→1
InterventionsAbemaciclib (Drug), LY3023414 (Drug), Letrozole (Drug)→Abemaciclib (Drug), Letrozole (Drug)
Eligibility criteria-1,290 characters
[...] d therapies, or for which no standard therapy is available.
For enrollment to Cohort 1: Participants must have ER-positive disease, defined as ≥ 1 p [...] pathology specimen analyzed in a CLIA-certified laboratory.
For enrollment to Cohort 2: Participants must have ER-negative disease, defined as < 1 percent of tumor cell nuclei being immunoreactive by 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 lea [...] mm with spiral CT scan, MRI, or [...]
Study description-282 characters
This is a Phase II clinical trial.
Phase withII aclinical safetytrials lead-in.Theevaluate safety lead-in will test the safety of a combination ofwhether investigational drugs andare alsoeffective tryagainst toa definespecific the appropriate dose of the combination to use for further studiesdisease.
"Investigational" means that the drugs are being studied.
The FDA (the U.S. Food and Drug Administration) has not approved LY3023414 as a treatment for any disease.
The FDA has not approved abemaciclib or letrozole for thisER+ specificendometrial diseasecancer, but both drugs have been approved fo [...] [...]
Study sitescontacts updated at 1 of 3 sites
Study title-20 characters
A Phase 2 Study of LY3023414 and Abemaciclib With or Without Letrozole in Recurrent or Persistent Endometrial Cancer
2019-02-06
minor
Study Status, Contacts/Locations v2
Study sitesdetails revised at 1 of 3 sites
2019-01-02
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-10-31→confirmed 2018-12-24
Study sites2→3