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New treatment option for Endometrial Cancer
Official title RESOLVE: Abemaciclib + Letrozole +/- Metformin or Gedatolisib in Endometrial Cancer
ClinicalTrials.gov ID: NCT03675893
What this study is testing
What is Letrozole?
Letrozole is an investigational medicine, being studied as a potential treatment for endometrial cancer.
Also referred to as Femara.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Participants must have cytologically or histologically confirmed endometrial cancer that is recurrent or metastatic and/or resistant to standard...
- Participants must have ER-positive disease, defined as ≥ 1 percent of tumor cell nuclei being immunoreactive by immunohistochemistry (IHC). If...
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter...
- Age ≥ 18 years
- ECOG performance status of 0 or 1
You likely can't join if
- Participants who have had chemotherapy, immune therapy, other investigational therapy, or major surgery within 4 weeks (6 weeks for nitrosoureas or...
- 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...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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
- Total 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) ≤ 3× institutional ULN
- Creatinine ≤ 1.5 × institutional ULN, OR
- Creatinine clearance ≥ 60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.
- For cohorts 6 and 7, patients must not have remaining ovarian function to be included. Women who have ovarian function are eligible but must be placed on hormonal suppression.
- The effects of the study agents on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use a medically approved contraceptive method during the treatment period and...
- Ability to understand and the willingness to sign a written informed consent 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 analysis in the form of a formalin-fixed paraffin embedded (FFPE) block or unstained slides. Note: confirmation of availability of archival tissue is the only...
- For Cohorts 6 and 7, participants must have HbA1c ≤6.4% and fasting plasma glucose (FPG) ≤140 mg/dL.
- For Cohort 6 and 7, patients must have wildtype TP53 as assessed either by immunohistochemistry or any CLIA-certified next-generation sequencing assay.
- For Cohort 7, patients must have received prior CDK4/6 inhibitor therapy and developed disease progression as deemed by the investigator. Patients who have stopped CDK4/6 inhibitor therapy because of intolerance are...
What rules you out
- 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...
- 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...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents that the participant will be administered.
- Participants who at the time of study enrollment are known to require concomitant therapy with moderate or strong CYP3A4 inducers, or strong inhibitors of CYP3A4. Due to potential drug interactions, concomitant use of...
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations...
- Use of known QT-prolonging drugs during screening or expected requirement for use during study therapy.
- Participants with histories or evidence of cardiovascular risk including any of the following: acute coronary syndromes (i.e. myocardial infarction or angina), coronary angioplasty, or stenting within 6 months prior to...
- Pregnant women are excluded from this study because the study agents are anti-cancer agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events...
- Individuals with a history of a different malignancy are ineligible with the following exceptions: individuals who have been treated and are disease-free for a minimum of 5 years prior to study enrollment, or...
- Known HIV-positive participants are ineligible because of the increased risk of lethal infections when treated with marrow-suppressive therapy.
- Participants with a history of uncontrolled hypertension despite optimal medical management, defined as systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg.
- For Cohorts 6 and 7: Inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF\>480 msec (determined by mean of triplicate ECGs at...
- For Cohorts 6 and 7, participants with type 1 diabetes or uncontrolled type 2 diabetes.
- For Cohorts 6 and 7, participants who have previously received any PI3K pathway inhibitors are ineligible. Up to 10 patients in Cohort 6 and up to 10 patients in Cohort 7 may have received prior mTOR inhibitor therapy...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.