RecruitingPhase 2

Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)

United States37 participantsStarted 2024-12-26

Plain-language summary

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).

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. Patients must have a histologic confirmed low-grade serous ovarian cancer with clinical evidence of reoccurrence.
✓. All patients must have measurable disease as defined by RECIST version 1.1.
✓. ECOG Performance status must be 0-1.
✓. Adequate bone marrow, hepatic and renal function as defined by the protocol.
✓. At least 4 weeks must have elapsed since the patient underwent any major surgery.
✓. At least 2 weeks must have elapsed since the patient received any radiation therapy.
✓. Patients must have signed an IRN approved informed consent and authorization permitting release of personal health information.
✓. All patients must be at least 18 years of age.

Exclusion criteria

✕. Patients who have previously received nab-sirolimus, any other mTOR inhibitor or any agent targeting the PI3K/AKT/mTOR pathway. (Prior MEKi is not exclusionary; up to one prior cytotoxic therapy is permissible.)
✕. Known intolerance or hypersensitivity to nab-sirolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus).
✕. Patients receiving chronic treatment with systemic steroids or another immunosuppressive agent if \>10 mg prednisone equivalent per day
✕. Patients with active or uncontrolled systemic infection requiring IV antibiotics, either ongoing or completed ≤7 days prior to enrollment.
✕. Known severely impaired lung function, including:
✕. Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification 1. To be eligible for this trial, patients should be class 2B or better.
✕. Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months prior to the first date of study therapy.
✕. Patients who are hypersensitive to albumin.

What they're measuring

The percentage of people in a treatment group who have a partial or complete response to the treatment within a certain period of time as measured by RECIST version 1.1.

Timeframe: 3 years

Incidence of patients with ≥ grade 3 adverse events.

Timeframe: 3 years

Trial details

NCT IDNCT06494150

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08

Contact for this trial

Lead Nurse

405-271-8777 SCC-IIT-Office@ouhsc.edu

View on ClinicalTrials.gov More Low Grade Ovarian Serous Adenocarcinoma trials