Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast

Part of paid clinical trials in Sioux Falls, South Dakota.

Sponsor
Avera McKennan Hospital & University Health Center
Study ID
NCT03154281
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • niraparib — DRUG
    Niraparib 100 mg will be administered orally once daily continuously. Niraparib will be administered as a flat-fixed dose (100mg, 200 mg, or 300 mg daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. Each dose should be swallowed whole without chewing. The consumption of water is permissible. Patients should take doses at approximately the same times each day, and record this information in the patient diary. Patients will be provided with a diary in which to record their intake of study drug. However, the actual number of doses taken by the patient must be calculated from the number of tablets dispensed and returned.
  • everolimus — DRUG
    Everolimus 5 mg tablets will be used. Everolimus will be self-administered orally on a daily basis and doses will either be 5 mg (1 tablet) thrice weekly or 5 mg daily depending on the cohort the patient is enrolled to. Each cycle will be 28 days; everolimus will be taken continuously with no rest between cycles.

Study Details

Open-label, cohort study to determine the feasibility and tolerability of the combination of daily niraparib and daily or thrice weekly everolimus for one 28-day cycle in patients with advanced ovarian and breast cancer.

Key Dates

Start date
Jul 26, 2017
Status verified
Jul 2024
Primary completion
Apr 21, 2021
Completion
May 1, 2023

Study Design

Enrollment
14 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    (each cycle is 28 days long) Everolimus 5mg daily on Mondays, Wednesdays, and Fridays Niraparib 100mg daily
  • Experimental: Cohort 2
    (each cycle is 28 days long) Everolimus 5 mg daily on Mondays, Wednesdays, and Fridays Niraparib 200 mg daily
  • Experimental: Cohort 3
    (each cycle is 28 days long) Everolimus 5 mg daily Niraparib 200 mg daily
  • Experimental: Cohort 4
    (each cycle is 28 days long) Everolimus 5 mg daily Niraparib 300 mg daily

Primary Outcome Measure

Number of Patients Who Developed Does-limiting Toxicity (DLT) [ Time Frame: From the start of treatment to 30 days after the first dose of study drug ]

Locations (1)

FacilityCityStateZIPSite coordinators
Avera Cancer InstituteSioux FallsSouth Dakota57105-

Find similar trials in Sioux Falls, SD

By condition
Breast cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
Avera Cancer Institute· Sioux Falls, SD

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