- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05997017
Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer
April 23, 2024 updated by: Aadi Bioscience, Inc.
A Phase 2 Multi-center Open-label Trial of Nab-Sirolimus in Combination With Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
A Phase 2 Multi-center Open-label Trial of nab-Sirolimus in Combination with Letrozole in Advanced or Recurrent Endometrioid Endometrial Cancer
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a prospective phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients with advanced or recurrent endometrioid endometrial carcinoma who have received 0-1 prior lines of chemotherapy in the recurrent/metastatic setting.
Patients will be treated with nab-sirolimus (given IV on Days 1 and 8 in a 21-day cycle, combined with letrozole (orally, daily) until unacceptable toxicity or disease progression, or until in the opinion of the Investigator the patient is no longer benefiting from therapy, or at patient discretion.
Study Type
Interventional
Enrollment (Estimated)
29
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aadi Bioscience Medical Information
- Phone Number: 1-888-246-2234
- Email: MedInfo@aadibio.com
Study Locations
-
-
Florida
-
Miami Beach, Florida, United States, 33140
- Recruiting
- Mount Sinai Comprehensive Cancer Center
-
Principal Investigator:
- Brian Slomovitz, MD
-
Contact:
- Michelle McClosky
- Phone Number: 305-674-2625
- Email: Michelle.Mcclosky@msmc.com
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- Recruiting
- Women's Cancer Center of Nevada
-
Contact:
- Jacky Amador
- Phone Number: 702-693-6870
- Email: jamador@wccenter.com
-
Contact:
- Thania Escamilla
- Phone Number: 702-693-6870
- Email: tescamilla@wccenter.com
-
Principal Investigator:
- Nicola M Spirtos, MD
-
-
New York
-
New York, New York, United States, 10065
- Recruiting
- Memorial Sloan Kettering Cancer Center
-
Contact:
- Angela Green, MD
- Phone Number: 646-888-4224
- Email: greena@mskcc.org
-
Principal Investigator:
- Angela Green, MD
-
-
North Carolina
-
Charlotte, North Carolina, United States, 28204
- Recruiting
- Levine Cancer Institute
-
Contact:
- Leah J Wilson, BS, RN, OCN
- Phone Number: 980-442-2333
- Email: leah.j.wilson@atriumhealth.org
-
Principal Investigator:
- Allison M Puechi, MD
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- Oklahoma University Stephenson Cancer Center
-
Principal Investigator:
- Lauren Dockery, MD
-
Contact:
- Christine Pappaterra
- Phone Number: 405-271-8777
- Email: Christine-pappaterra@ouhsc.edu
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02905
- Recruiting
- Women & Infants Hospital
-
Principal Investigator:
- Cara Mathews, MD
-
Contact:
- Pamela Smith
- Phone Number: 48181 401-274-1122
- Email: oncologyresearch@wihri.org
-
-
Texas
-
Tyler, Texas, United States, 75702
- Recruiting
- Texas Oncology - Tyler
-
Principal Investigator:
- Anna Priebe, MD
-
Contact:
- Shelly Maxfield, CCRP
- Phone Number: 903-579-9840
- Email: shelly.maxfield@usoncology.com
-
-
Washington
-
Seattle, Washington, United States, 98104
- Recruiting
- Swedish Cancer Institute
-
Principal Investigator:
- Fernanda Musa, MD
-
Contact:
- Anh Lam
- Phone Number: 206-386-2227
- Email: Anh.lam@swedish.org
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 are permitted to have received adjuvant chemotherapy and no more than 1 line of chemotherapy in the recurrent/advanced/metastatic setting.
- 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 adequately recovered from the acute toxicities of any prior therapy, including neuropathy, to Grade ≤1.
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 a negative serum pregnancy test (beta human chorionic gonadotropin [β-hCG]) result at screening and agree to ongoing pregnancy testing during the course of the study, and after the end of study treatment. A second form of birth control is required even if she has had a tubal ligation.
- 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 study medication. The reliability of sexual abstinence should be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the patient.
- 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
Exclusion Criteria:
- 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 cardiac arrhythmia or any other clinically significant cardiac disease.
- 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 [PFTs] are not required to be performed unless clinically indicated).
- 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, carcinoma in situ of the cervix, resected incidental prostate cancer, certain low grade hematologic malignancies (eg, chronic lymphocytic leukemia [CLL], follicular lymphoma, etc), or other adequately treated carcinoma in situ may be eligible, after discussion with the Medical Monitor.
- 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, telithromycin; strong inducers include rifampin and rifabutin). These agents must be discontinued prior to first dose of nab-sirolimus.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endometrioid Endometrial Cancer
Patients with advanced or recurrent endometrioid endometrial carcinoma
|
Prospective Phase 2, open-label, multi-institutional study to evaluate the efficacy and safety of nab-sirolimus + letrozole in patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate (ORR)
Time Frame: 12 Months
|
ORR, defined as the proportion of patients with best overall response (BOR) of confirmed partial response (PR) or complete response (CR) from the time of study treatment initiation until progression of disease (PD) as determined by the Investigator using RECIST v1.1.
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of response (DOR)
Time Frame: 12 Months
|
Determined for patients with BOR of confirmed CR or PR
|
12 Months
|
Disease Control Rate (DCR): CR or PR
Time Frame: 12 Months
|
BOR of confirmed CR or PR (either of any duration) or stable disease (SD) following study treatment initiation (by IRR)
|
12 Months
|
Time to response (TTR)
Time Frame: 12 Months
|
Time from study treatment initiation to initial measurement of CR or PR, where CR or PR is subsequently confirmed
|
12 Months
|
Progression-free survival (PFS)
Time Frame: 12 Months
|
Number of months from study treatment initiation to the date of disease progression 3 or death due to any cause
|
12 Months
|
Overall survival (OS)
Time Frame: 24 Months
|
Number of months from study treatment initiation to the date of death due to any cause or last follow up date if alive
|
24 Months
|
Incidence and severity
Time Frame: 12 Months
|
Of treatment-emergent and treatment-related adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
|
12 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Willis Navarro, MD, Aadi Bioscience
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 28, 2023
Primary Completion (Estimated)
March 1, 2025
Study Completion (Estimated)
October 1, 2026
Study Registration Dates
First Submitted
August 10, 2023
First Submitted That Met QC Criteria
August 10, 2023
First Posted (Actual)
August 18, 2023
Study Record Updates
Last Update Posted (Actual)
April 24, 2024
Last Update Submitted That Met QC Criteria
April 23, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Disease Attributes
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Carcinoma
- Recurrence
- Endometrial Neoplasms
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Sirolimus
Other Study ID Numbers
- EEC-201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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