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

NCT06494150 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: OU-SCC-NARETO
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Low Grade Ovarian Serous Adenocarcinoma

Keywords

Ovarian Cancer; Endocrine Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  The primary analysis is preplanned to occur when the last patient enrolled has been treated for 6 months.

  3 years

• Incidence of patients with ≥ grade 3 adverse events.

  Review of adverse events that have occurred to determine the toxicity for the proposed treatment regimen.

  3 years

Secondary Outcomes (2)

• Proportion of patients who have remained progression-free for 6-months.

  3 years

• Duration of response from a subjects first scan to disease progression or death.

  Up to 3 years

Study Arms (1)

nab-sirolimus + Fulvestrant

EXPERIMENTAL

Patients will be treated with the combination nab-sirolimus (100 mg/m2 intravenous injection on day 1 and 8 of each 21-day cycle) and fulvestrant (500mg intramuscular injection on days 1 and 15 of cycle 1 and then every 21 days).

Drug: nab-Sirolimus; Drug: Fulvestrant

Interventions

nab-Sirolimus DRUG

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

Also known as: Fyarro

nab-sirolimus + Fulvestrant

Fulvestrant DRUG

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

Also known as: Faslodex

nab-sirolimus + Fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• 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:
• CTCAE grade 2 (or greater) hypoxia (decreased oxygen saturation with exercise \[e.g., pulse oximeter \<88%\]; intermittent supplemental oxygen)
• 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.
• Patients who are pregnant or breast-feeding.
• Patients with brain metastases. Patients recently treated for brain metastases are eligible as long as they have been off steroids or RT for at least 2 weeks.
• Known HIV-infected patients requiring anti-retroviral therapy that are strong CYP3A4 inhibitors or inducers.
• Patients with active bleeding or pathologic conditions that carry high risk of bleeding, such as known bleeding disorder or coagulopathy.
• Patients who are currently part of or have participated in any clinical investigation with an investigational drug within 28 days prior to dosing or 5 half-lives whichever is shorter.
• Active Hepatitis B or Hepatitis C, with detectable viral load.
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Sponsors & Collaborators

• University of Oklahoma: lead
• Aadi Bioscience, Inc.: collaborator

Study Sites (1)

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73117, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Christina Washington, MD

  OU Health Stephenson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Nurse

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single arm phase II study proposes to evaluate the efficacy and safety of nab-sirolimus + endocrine therapy in patients with recurrent LGSOC.

Study Record Dates

• First Submitted: July 2, 2024
• First Posted: July 10, 2024
• Study Start: December 26, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)