A Study of Niraparib in Combination With Brivanib in Recurrent Ovarian Cancer

Sponsor
Hunan Cancer Hospital
Study ID
NCT03895788
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • niraparib — DRUG
    Niraparib will be administered as a flat-fixed dose (100mg or 200 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.
  • Brivanib — DRUG
    Brivanib will be administered as a flat-fixed dose (200mg, 400 mg, or 600 mg daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area.

Study Details

Open-label, cohort study to determine the safety and tolerability of the combination of daily niraparib and daily brivanib for one 28-day cycle in patients with advanced ovarian cancer.

Key Dates

Start date
Jan 14, 2019
Status verified
Mar 2019
Primary completion
Dec 31, 2019
Completion
Mar 31, 2020

Study Design

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

Arms

  • Experimental: niraparib and brivanib
    Subjects will be assigned into niraparib 100mg+brivanib 200mg, niraparib 200mg+brivanib 200mg, niraparib 200mg+brivanib 400mg, niraparib 200mg+brivanib 600mg dose group at the first day of the first cycle.

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: 1 year ]

Central Contacts

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