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

NCT02855697 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-02-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Olaparib

300 mg taken twice daily, equivalent to a total daily dose of 600 mg

DRUG

Cediranib

20mg dose of cediranib was selected for this study

DRUG

Platinum-based Chemotherapy

1 or 2 two courses of platinum-based chemotherapy administered depending on trial entry point.

Sponsors & Collaborators

  • Clinical Trials Unit, Manchester

    collaborator OTHER

  • The Christie NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Gordon Jayson, MD, Prof. · The Christie National Health Service (NHS) Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-26
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02855697 on ClinicalTrials.gov