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Hormone Therapy

Nab-Sirolimus + Endocrine Therapy for Ovarian Cancer

Phase 2

Waitlist Available

Led By Christina Washington, MD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have a histologic confirmed low-grade serous ovarian cancer with clinical evidence of reoccurrence.

ECOG Performance status must be 0-1.

Must not have

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test the effectiveness and safety of a combination of nab-sirolimus and endocrine therapy in patients with recurrent low grade serous ovarian cancer.

Who is the study for?

This trial is for adults with recurrent low-grade serous ovarian cancer. Participants must be in good physical condition (ECOG 0-1), have measurable disease, and adequate organ function. They should not have had major surgery or radiation within the last 4 weeks and 2 weeks respectively, and must agree to effective contraception if of childbearing potential.

What is being tested?

The study is testing the combination of nab-Sirolimus, a targeted therapy drug, with Fulvestrant, an endocrine therapy. It aims to assess how safe and effective this combo is for patients who've seen their ovarian cancer return after previous treatments.

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression due to nab-Sirolimus (like increased risk of infections) and hormonal changes from Fulvestrant. Specific side effects are not listed but could align with those typical of mTOR inhibitors and hormone therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ovarian cancer is low-grade and has come back.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken drugs targeting the mTOR pathway, except possibly one chemotherapy or a MEK inhibitor.

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I am allergic to certain cancer medications like sirolimus.

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I have severe lung issues and need oxygen sometimes.

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I have not had a stroke or mini-stroke in the last 6 months.

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I am HIV-positive and on medication that strongly affects drug metabolism.

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I do not have any conditions that increase my risk of bleeding.

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I am on a daily dose of more than 10 mg of prednisone or similar medication.

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I have active Hepatitis B or C with a detectable viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of patients with ≥ grade 3 adverse events.

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.

Secondary study objectives

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

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: nab-sirolimus + FulvestrantExperimental Treatment2 Interventions

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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~4030

nab-Sirolimus

2015

Completed Phase 2

~40