Low Grade Ovarian Serous AdenocarcinomaPhase 2NCT06494150
Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)
A Phase 2 study testing nab-Sirolimus and Fulvestrant in people with Low Grade Ovarian Serous Adenocarcinoma, run by University of Oklahoma at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low Grade Ovarian Serous Adenocarcinoma
- What is being tested?
- nab-Sirolimus and Fulvestrant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Dec 2024to Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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:
- CTCAE grade 2 (or greater) hypoxia (decreased oxygen saturation with exercise [e.g., pulse oximeter <88%]; intermittent supplemental oxygen)
Show all 18Show fewer
- 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.
- Uncontrolled hypertension (systolic blood pressure ≥160 mm-Hg and/or diastolic blood pressure ≥100 mm Hg).
- Patients who are unable to discontinue concomitant medication with CYP3A4 strong inducers (eg, rifampin, rifabutin), and known CYP3A4 substrates with a narrow therapeutic window (eg, fentanyl, alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, or terfenadine) at least 5 half-lives prior to receiving the first dose of nab-sirolimus. Medical Monitor approval required if patient is taking any of the medications listed above.
Trial locations and contacts
1 site in 1 country.
United States1 site
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Phase II Study of Nab-sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer
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).
Read the 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.
- Conditions
- Low Grade Ovarian Serous Adenocarcinoma
- Being tested
- nab-Sirolimus, Fulvestrant
- Keywords
- Ovarian Cancer, Endocrine Therapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nab-SirolimusDrug
Also called Fyarro
nab-Sirolimus will be administered by intravenous infusion at 100mg/m2 on days 1 and 8 of each 21-day cycle
FulvestrantDrug
Also called Faslodex
Fulvestrant will be administered by intramuscular injection at 500mg on days 1 and 15 of cycle 1 and then every 21 days
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: nab-Sirolimus; Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 years
Secondary outcomes (2)
Proportion of patients who have remained progression-free for 6-months.
Proportion of patients on the proposed treatment combination who have not had any disease progression for at least 6 months.
Measured: 3 years
Duration of response from a subjects first scan to disease progression or death.
Determine the length of time from the date subjects have partial or complete response to treatment until the date the subjects have disease progression.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start26 Dec 2024
- Primary completionAug 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Grade Ovarian Serous AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm phase II study proposes to evaluate the efficacy and safety of nab-sirolimus + endocrine therapy in patients with recurrent LGSOC.
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Aadi Bioscience, Inc.
- Responsible party
- Sponsor
- Investigators
- Christina Washington, MD, Principal investigator, OU Health Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494150
- Sponsor's protocol ID
- OU-SCC-NARETO
- Status last verified
- Jun 2026
- First submitted
- 2 Jul 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Nab-sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06494150
- Acronym / sponsor ID
- OU-SCC-NARETO
- Conditions
- Low Grade Ovarian Serous Adenocarcinoma
- Keywords
- Ovarian Cancer, Endocrine Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Aadi Bioscience, Inc.
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm phase II study proposes to evaluate the efficacy and safety of nab-sirolimus + endocrine therapy in patients with recurrent LGSOC.
| Arm | Type | Receives |
|---|---|---|
| nab-sirolimus + Fulvestrant | Experimental | Drug: nab-Sirolimus, Drug: FulvestrantPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nab-SirolimusAlso: Fyarronab-Sirolimus will be administered by intravenous infusion at 100mg/m2 on days 1 and 8 of each 21-day cycle | Drug | nab-sirolimus + Fulvestrant |
| FulvestrantAlso: FaslodexFulvestrant will be administered by intramuscular injection at 500mg on days 1 and 15 of cycle 1 and then every 21 days | Drug | nab-sirolimus + Fulvestrant |
Primary outcome
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.
Time frame: 3 years
The primary analysis is preplanned to occur when the last patient enrolled has been treated for 6 months.
Incidence of patients with ≥ grade 3 adverse events.
Time frame: 3 years
Review of adverse events that have occurred to determine the toxicity for the proposed treatment regimen.
2 secondary outcomes
Proportion of patients who have remained progression-free for 6-months.
Time frame: 3 years
Duration of response from a subjects first scan to disease progression or death.
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Low Grade Ovarian Serous Adenocarcinoma
RecruitingPhase 1
Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma
Active, not recruitingPhase 2
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
Fallopian Tube Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma
Active, not recruitingPhase 2
Study of Pembrolizumab Combination With Chemotherapy in Platinum-sensitive Recurrent Low-grade Serous Ovarian Cancer
Ovarian Cancer, Low Grade Serous Carcinoma
Not yet recruitingPhase 2
Imlunestrant/Abemaciclib/Selinexor in Ovarian and Endometrial
Low Grade Ovarian Serous Adenocarcinoma, Endometrial Cancer
Active, not recruitingPhase 2
Fulvestrant Plus Abemaciclib in Women With Advanced Low Grade Serous Carcinoma
Malignant Neoplasms of Female Genital Organs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Washington, MD principal investigator
OU Health Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nab-Sirolimus and Fulvestrant in people with Low Grade Ovarian Serous Adenocarcinoma, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.