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New treatment option for Endometrial Cancer
Official title Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer
ClinicalTrials.gov ID: NCT05997017
What this study is testing
What is nab-sirolimus?
nab-sirolimus is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as ABI-009.
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
- A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
- 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
You may be able to join if
- Patients must have clinically confirmed advanced or recurrent endometrioid endometrial carcinoma. Histologic documentation of the recurrence is...
- All patients must have 1 or more measurable target lesion at baseline by computed tomography (CT; or magnetic resonance imaging [MRI] if CT scans are...
- Patients must have EEC that is metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity.
- Prior treatment history:
- Adjuvant setting - treatment with chemotherapy, hormonal therapy,checkpoint inhibitors, and/or other therapy is permitted as long as theadjuvant...
You likely can't join if
- Prior treatment with an mTOR inhibitor, including nab-sirolimus.
- Patients with known inactivating TSC1 or TSC2 alterations (based on tissue or liquid next generation sequencing [NGS]) unless the PRECISION 1 study...
- Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment.
- Patients with primary refractory disease (ie, those who have never achieved a complete or partial response to prior therapy) are not permitted on...
- Patients with the following are excluded:
- Known or suspected brain metastases.
See the full eligibility criteria
Who can join
- Patients must have clinically confirmed advanced or recurrent endometrioid endometrial carcinoma. Histologic documentation of the recurrence is suggested but not required.
- All patients must have 1 or more measurable target lesion at baseline by computed tomography (CT; or magnetic resonance imaging [MRI] if CT scans are contraindicated) as defined by RECIST version 1.1.
- Patients must have EEC that is metastatic or locally advanced where surgical resection is not an option or likely to result in severe morbidity.
- Prior treatment history:
- Adjuvant setting - treatment with chemotherapy, hormonal therapy,checkpoint inhibitors, and/or other therapy is permitted as long as theadjuvant therapy ended ≥6 months from enrollment.
- Recurrent/advanced/metastatic setting - treatment with 0-1 prior chemotherapy regimens is permitted (patients may be naïve to chemotherapy); chemotherapy must have been completed ≥3 months prior to enrollment. Patients...
- Non-chemotherapy-based treatment (eg, checkpoint inhibitors, hormonal therapy, and/or small molecule agents) is permitted at any point as long as therapy ended ≥4 weeks prior to enrollment.
- Patients who have received prior therapy in the recurrent/advanced/metastatic setting must have achieved a complete or partial response(investigator-assessed) to at least 1 therapy.
- Age: 18 years or older.
- Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate liver function:
- Total bilirubin ≤1.5 × upper limit of normal (ULN) (unless due to Gilbert's syndrome, then ≤3 × ULN)
- Aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if attributable to liver metastases)
- Adequate renal function: creatinine clearance (CrCL) ≥30 mL/min based on Cockcroft-Gault
- Adequate hematologic parameters:
- Absolute neutrophil count (ANC) ≥1.0 × 109/L (growth factor support allowed)
- Platelet count ≥100,000/mm3 (100 × 109/L) (transfusion and/or growth factor support allowed)
- Hemoglobin ≥8.0 g/dL (transfusion and/or growth factor support allowed)
- Fasting serum triglyceride must be ≤300 mg/dL; fasting serum cholesterol must be less than or equal to 350 mg/dL.
- Minimum of 4 weeks since any major surgery, completion of radiation, or completion of prior systemic anticancer therapy, or at least 5 half-lives if the prior therapy is a single agent small-molecule therapeutic, and...
- Non-pregnant and non-breastfeeding female:
- Females of childbearing potential must agree to use effective contraception or abstinence without interruption from 28 days prior to starting nab-Sirolimus through 3 months after the last dose of nab-Sirolimus and have...
- Sexual abstinence is considered a highly effective contraceptive method only if defined as refraining from heterosexual intercourse from 28 days prior to starting study medication throughout 3 months after last dose of...
- The patient understands and signs the informed consent.
- Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.
- Patients with a known history of human immunodeficiency virus (HIV)infection are eligible if:
- There has been no acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection in 12 months prior to enrollment.
- The patient has been receiving an antiretroviral therapy regimen for≥4 weeks and the HIV viral load is \<400 copies/mL prior to enrollment.
- Antiretroviral therapy regimen does not include strong cytochrome(CYP)3A4 inhibitors or inducers
What rules you out
- Prior treatment with an mTOR inhibitor, including nab-sirolimus.
- Patients with known inactivating TSC1 or TSC2 alterations (based on tissue or liquid next generation sequencing [NGS]) unless the PRECISION 1 study (NCT05103358) has been closed to enrollment.
- Severe (Grade ≥3) ongoing infection requiring parenteral or oral anti-infective treatment, either ongoing or completed ≤7 days prior to enrollment.
- Patients with primary refractory disease (ie, those who have never achieved a complete or partial response to prior therapy) are not permitted on study.
- Patients with the following are excluded:
- Known or suspected brain metastases.
- Severe heart disease defined as unstable angina pectoris, New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction ≤6 months prior to first study treatment, serious uncontrolled...
- Severe lung disease defined as a diffusing capacity for carbon monoxide (DLCO) that is ≤50% of normal predicted value and/or an O2 saturation ≤88% at rest on room air (Note: spirometry and pulmonary function tests...
- Nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy.
- A history of malignancies other than the one under treatment unless the patient is disease-free for more than 5 years from completion of therapy administered with curative intent. Controlled non-melanoma skin cancers...
- Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg
- Patients with history of interstitial lung disease and/or pneumonitis, or pulmonary hypertension.
- Active hepatitis B and/or hepatitis C infection and detectable viral load despite antiviral therapy
- Required use of concomitant medications with strong CYP3A4 interactions (induction or inhibition) should be discontinued (strong inhibitors include ketoconazole, itraconazole, voriconazole, erythromycin, clarithromycin...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Miami Beach, Florida, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Providence, Rhode Island, United States
- Tyler, Texas, United States
- Seattle, Washington, 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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Miami Beach, Florida, United States; Las Vegas, Nevada, United States; New York, New York, United States; Charlotte, North Carolina, United States; Oklahoma City, Oklahoma, United States and 3 more location(s). 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.