Post-Marketing Observational Prospective Study to Assess Real World Outcomes and the Risk of Myelodysplastic syndromes (MDS)/acute myeloid leukaemia (AML) in Platinum Sensitive Relapsed breast cancer susceptibility gene (BRCA) Mutated Ovarian Cancer Patients Treated with Lynparza (olaparib); the LOCALISE Study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/18336
• EU PAS number:
  EUPAS13757
• Study ID:
  18336
• Official title and acronym:
  Post-Marketing Observational Prospective Study to Assess Real World Outcomes and the Risk of Myelodysplastic syndromes (MDS)/acute myeloid leukaemia (AML) in Platinum Sensitive Relapsed breast cancer susceptibility gene (BRCA) Mutated Ovarian Cancer Patients Treated with Lynparza (olaparib); the LOCALISE Study
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  Denmark

  Germany

  Italy

  Korea, Republic of

  Netherlands

  Poland

  Spain

  Sweden
• Study description:
  This study is designed to collect real world outcomes in patients treated with Lynparza, will be conducted to comply with Post Authorisation Measures (PAM) in the EU and is part of additional Pharmacovigilance activities in the RMP. This non- interventional, prospective post-marketing study of Lynparza will be conducted among patients aged 18 and older with germline and/or somatic breast cancer susceptibility gene (BRCA) mutated (BRCAm) platinum sensitive relapsed high grade serous epithelial ovarian cancer, who are in response to the most recent platinum-based chemotherapy and who are on or initiating Lynparza maintenance treatment. The study will follow a group of individuals who have ovarian cancer and who share important disease factors, to collect information on outcomes and the risk of developing MDS/AML in real world, routine clinical practice. The medicines administered to the patients over the course of the study will be selected by the patients’ own physician in agreement with the patients and will be in line with the physician’s standard practice, these treatments will include Lynparza. The prescription of Lynparza will be clearly separated from the decision to include the patient in the study and this decision has to be taken prior to informed consent form (ICF) signing. Following receipt of the final outcome of the PRACs assessment of the LOCALISE protocol on 01/12/16, the PRAC concluded that this PASS study was not feasible. The commitment related to MDS/AML remains in the EU, but instead of a PASS this will now be dealt with by providing them with a summary of data emerging from our ongoing clinical trial program. As a consequence, the LOCALISE PASS will no longer be conducted. Data Collection never started, but as for trial report, date of study closure has been used for actual milestone. There will be no study report.
• Study status:
  Finalised

Research institutions and networks

Institutions

AstraZeneca

Multiple centres: 78 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned: 18/09/2016

Actual: 18/09/2015

Study start date

Planned: 17/03/2017

Actual: 01/12/2016

Data analysis start date

Planned: 06/02/2023

Date of final study report

Planned: 23/04/2023

Actual: 01/12/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

D0816R00008