RecruitingPhase 2NCT06494150

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

Phase II Study of Nab-sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer


Sponsor

University of Oklahoma

Enrollment

37 participants

Start Date

Dec 26, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether combining nab-sirolimus (a targeted mTOR inhibitor) with hormone therapy can help control low-grade serous ovarian cancer that has come back after prior treatment. **You may be eligible if...** - You have been diagnosed with low-grade serous ovarian cancer that has come back - Your cancer is measurable on imaging - You are in good physical condition (ECOG 0–1) - At least 4 weeks have passed since your last major surgery and at least 2 weeks since any radiation - Your blood counts and organ function meet minimum requirements **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have severe liver, kidney, or bone marrow problems - You are pregnant or breastfeeding - You have significant uncontrolled infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGnab-Sirolimus

nab-Sirolimus will be administered by intravenous infusion at 100mg/m2 on days 1 and 8 of each 21-day cycle

DRUGFulvestrant

Fulvestrant will be administered by intramuscular injection at 500mg on days 1 and 15 of cycle 1 and then every 21 days


Locations(1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

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NCT06494150


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