Multi-maintenance Olaparib After Disease Recurrence in Participants With Platinum Sensitive BRCAm High Grade Serous Ovarian Cancer

Sponsor
The Christie NHS Foundation Trust
Study ID
NCT02855697
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    300 mg taken twice daily, equivalent to a total daily dose of 600 mg
  • Cediranib — DRUG
    20mg dose of cediranib was selected for this study
  • Platinum-based Chemotherapy — DRUG
    1 or 2 two courses of platinum-based chemotherapy administered depending on trial entry point.

Study Details

PARP inhibitors, such as olaparib, significantly improve progression free survival (PFS) in participants with recurrent, platinum-sensitive high-grade serous/endometrioid ovarian cancer (HGS/EOC), who harbour a germline mutation in BRCA 1 or 2 genes. Despite some of the most impressive hazard ratios seen in ovarian oncology, such improvements in PFS have not translated into improved overall survival (OS) advantage potentially because maintenance poly ADP ribose polymerase inhibitors (PARPi) are only being administered during a single remission. Here the investigators will test the feasibility of administering a second course of olaparib in participants who have recurrent platinum-sensitive HGS/EOC.

Key Dates

Start date
May 26, 2017
Status verified
Feb 2022
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

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

Arms

  • Experimental: Olaparib +/- cediranib
    Patients are administered two courses of maintenance olaparib following chemotherapy. It is possible for patients to take cediranib during the second course of olaparib if recommended as per the protocol.

Primary Outcome Measure

To determine the feasibility of administering a second course of maintenance olaparib for more than 6 months (26 weeks) to participants with recurrent platinum-sensitive HGS/EOC who have been previously treated with olaparib. [ Time Frame: 6 months after the last patient has started the second course of olaparib ]

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