A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment.

Part of paid clinical trials in Anchorage, Alaska.

Sponsor
AstraZeneca
Study ID
NCT04239014
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    Olaparib 300 mg BD (2 × 150 mg tablets) continually in the olaparib monotherapy and ceralasertib+olaparib treatment arms.
  • Ceralasertib — DRUG
    Ceralasertib 160 mg QD (2 × 80 mg tablets) from Days 1 to 7 (inclusive) of every 28-day cycle.
  • Placebo to match olaparib — DRUG
    Per olaparib

Study Details

To investigate the effectiveness and tolerability of a second maintenance treatment in participants with platinum-sensitivity relapsed (PSR) epithelial ovarian cancer, who have previously received PARPi maintenance treatment and who have benefit (complete response \[CR\] or partial response \[PR\]) or stable disease (SD) from further platinum based chemotherapy.

Key Dates

Start date
Aug 7, 2020
Status verified
Mar 2021
Primary completion
Jan 25, 2021
Completion
Jan 25, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1 (ceralasertib+olaparib)
    Participants received ceralasertib 160 mg QD PO on Days 1 to 7 plus olaparib 300 mg BD PO continuous (28 day cycle).
  • Experimental: Arm 2 (olaparib monotherapy)
    Olaparib 300 mg BD PO daily continuous.
  • Experimental: Arm 3 (placebo)
    Placebo to match olaparib BD PO daily continuous.

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: To assess from the time of randomization until the date of objective disease progression or death (by any cause in the absence of progression) or approximately up to 2.5 years. ]

Locations (22)

FacilityCityStateZIPSite coordinators
Research SiteAnchorageAlaska99508-
Research SiteLa JollaCalifornia92093-0021-
Research SiteLong BeachCalifornia90806-
Research SiteLos AngelesCalifornia90048-
Research SiteWest HollywoodCalifornia97210-
Research SiteHartfordConnecticut06106-
Research SiteTampaFlorida33612-
Research SiteAtlantaGeorgia30342-
Research SiteLouisvilleKentucky40202-
Research SiteCovingtonLouisiana70433-
Research SiteFlorham ParkNew Jersey07932-
Research SiteTeaneckNew Jersey07666-
Research SiteClevelandOhio44106-
Research SiteOklahoma CityOklahoma73104-
Research SiteTulsaOklahoma74146-
Research SitePortlandOregon97210-
Research SiteAbingtonPennsylvania19001-
Research SitePhiladelphiaPennsylvania19104-
Research SiteSioux FallsSouth Dakota57105-1599-
Research SiteSioux FallsSouth Dakota57105-
Research SiteHoustonTexas77030-
Research SiteSeattleWashington98104-

Find similar trials in Anchorage, AK

By condition
Ovarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Research Site· Anchorage, AKResearch Site· La Jolla, CAResearch Site· Long Beach, CAResearch Site· Los Angeles, CAResearch Site· West Hollywood, CAResearch Site· Hartford, CT

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