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

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

July 26, 2017

Primary Completion Date

April 21, 2021

Study Completion Date

May 1, 2023

Conditions
Breast CancerOvarian Cancer
Interventions
DRUG

niraparib

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.

DRUG

everolimus

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.

Trial Locations (1)

57105

Avera Cancer Institute, Sioux Falls

All Listed Sponsors
lead

Avera McKennan Hospital & University Health Center

OTHER

NCT03154281 - Evaluation of the Safety and Tolerability of Niraparib With Everolimus in Advanced Gynecologic Malignancies and Breast | Biotech Hunter | Biotech Hunter