Actively Recruiting
Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)
Led by University of Oklahoma · Updated on 2026-02-23
37
Participants Needed
1
Research Sites
244 weeks
Total Duration
On this page
Sponsors
U
University of Oklahoma
Lead Sponsor
A
Aadi Bioscience, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This single arm phase II study proposes to evaluate the efficacy and safety of nab-sirolimus + endocrine therapy (Fulvestrant) in patients with recurrent low grade serous ovarian cancer (LGSOC).
CONDITIONS
Official Title
Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic confirmed low-grade serous ovarian cancer with clinical evidence of recurrence
- Measurable disease as defined by RECIST version 1.1
- ECOG Performance status of 0-1
- Adequate bone marrow, liver, and kidney function
- At least 4 weeks since any major surgery
- At least 2 weeks since any radiation therapy
- Signed informed consent and permission to release personal health information
- At least 18 years old
- Prior or concurrent malignancy allowed if it won't interfere with safety or treatment assessment
- Negative pregnancy test for those of childbearing potential and use of highly effective contraception during and after treatment
You will not qualify if you...
- Previous treatment with nab-sirolimus, other mTOR inhibitors, or agents targeting the PI3K/AKT/mTOR pathway
- Known allergy to nab-sirolimus or rapamycin analogs
- Chronic treatment with systemic steroids over 10 mg prednisone equivalent per day
- Active or uncontrolled systemic infection requiring IV antibiotics
- Severely impaired lung function with significant hypoxia
- History or symptoms of cardiac disease with a risk assessment worse than NYHA class 2B
- Stroke or transient ischemic attack within 6 months before starting study therapy
- Allergy to albumin
- Pregnant or breastfeeding
- Brain metastases unless off steroids or radiation therapy for at least 2 weeks
- HIV infection requiring certain antiretroviral drugs
- Active bleeding disorders or high risk for bleeding
- Participation in another investigational drug study within 28 days or 5 half-lives
- Active hepatitis B or C infection with detectable viral load
- Uncontrolled high blood pressure
- Unable to stop medications that strongly affect CYP3A4 enzyme before starting nab-sirolimus without medical approval
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73117
Actively Recruiting
Research Team
L
Lead Nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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