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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT06494150
Phase
PHASE2
Status
Recruiting
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Conditions

  • Low Grade Ovarian Serous Adenocarcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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).

Key Dates

Start date
Dec 26, 2024
Status verified
Feb 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: nab-sirolimus + Fulvestrant
    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).

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73117
Christina Washington, MD
[email protected]
405-271-8777
Christina Washington, MD (PRINCIPAL_INVESTIGATOR)

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By research site
OU Health Stephenson Cancer Center· Oklahoma City, OK

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