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Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06494150•University of Oklahoma

View on ClinicalTrials.gov

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).

Detailed Description

Patients with histologic confirmed Low Grade Serous Ovarian Cancer with measurable disease should have a pre-dose tumor biopsy. Patients will receive proposed treatment regimen of nab-sirolimus on days 1 and 8 and fulvestrant on days 1 and 15 of cycle 1 and then every 21-day cycle as long as there is evidence that tumor is not growing or spreading and they are not having any unacceptable, bad side effects. Patients will be monitored during treatment with tests and exams and after treatment completion for up to 2 years.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Patients must have a histologic confirmed low-grade serous ovarian cancer with clinical evidence of reoccurrence.
•2. All patients must have measurable disease as defined by RECIST version 1.1.
•3. ECOG Performance status must be 0-1.
•4. Adequate bone marrow, hepatic and renal function as defined by the protocol.
•5. At least 4 weeks must have elapsed since the patient underwent any major surgery.
•6. At least 2 weeks must have elapsed since the patient received any radiation therapy.
•7. Patients must have signed an IRN approved informed consent and authorization permitting release of personal health information.
•8. All patients must be at least 18 years of age.
•9. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
•10. Patients of childbearing potential must have a negative serum pregnancy test prior to the study entry and be practicing a highly effective form of contraception. During the study treatment and for 12 weeks after stopping nab-sirolimus and 12 months after stopping Fulvestrant. Highly effective contraceptive methods include combination of any two of the following as defined in the protocol.
+2 more criteria

Exclusion Criteria

•1. 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.)
•2. Known intolerance or hypersensitivity to nab-sirolimus or other rapamycin analogs (e.g. sirolimus, temsirolimus).
•3. Patients receiving chronic treatment with systemic steroids or another immunosuppressive agent if \>10 mg prednisone equivalent per day
•4. Patients with active or uncontrolled systemic infection requiring IV antibiotics, either ongoing or completed ≤7 days prior to enrollment.
•5. Known severely impaired lung function, including:
•* CTCAE grade 2 (or greater) hypoxia (decreased oxygen saturation with exercise \[e.g., pulse oximeter \<88%\]; intermittent supplemental oxygen)
•6. 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.
•7. Cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months prior to the first date of study therapy.
•8. Patients who are hypersensitive to albumin.
•9. Patients who are pregnant or breast-feeding.
+5 more criteria

Locations (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Key Dates

Start Date

December 26, 2024

Primary Completion Date

August 1, 2027

Completion Date

September 1, 2029

Last Updated

February 23, 2026

Enrollment

ESTIMATED participants

Conditions

Low Grade Ovarian Serous Adenocarcinoma

Interventions

nab-Sirolimus

DRUG

Fulvestrant

DRUG

Contacts

Lead Nurse

CONTACT

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