Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Sarah E Taylor
Study ID
NCT04377087
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Olaparib is a potent oral poly (ADP-ribose) polymerase (PARP) inhibitor that induces synthetic lethality in BRCA1/2 deficient tumor cells through the formation of double-stranded DNA breaks which cannot be accurately repaired, which leads to disruption of cellular homeostasis and cell death.

Study Details

The purpose of this study is to test if delaying the start of the olaparib until there is a rise in a tumor marker called CA-125 will result in a longer time until the next or different treatment for the patient's cancer. The study will also evaluate how delaying the start of maintenance therapy will affect symptoms; physical functioning; quality of life; and impact on finances.

Key Dates

Start date
Jun 29, 2020
Status verified
Jul 2024
Primary completion
May 31, 2023
Completion
May 31, 2023

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib
    Olaparib dosed at 300mg orally twice daily, started when CA125 rises by two-fold of nadir value.

Primary Outcome Measure

Time to Next Therapy [ Time Frame: Up to 35 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Magee Women's Hospital of UPMCPittsburghPennsylvania15213-

Find similar trials in Pittsburgh, PA

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Magee Women's Hospital of UPMC· Pittsburgh, PA

Related Studies