Study identification

EU PAS number

EUPAS1000000323

Study ID

1000000323

Official title and acronym

A Post-Authorization Safety Study (PASS) to characterize the risk of secondary primary malignancy including MDS/AML among metastatic prostate cancer patients exposed to AKEEGA (niraparib/abiraterone acetate fixed-dose combination tablet) plus Prednisone/Prednisolone

DARWIN EU® study

No

Study countries

Sweden

Study description

The primary objective is to estimate the incidence of myelodysplastic syndrome / acute myeloid leukemia and other second primary malignancies among patients exposed to AKEEGA and other BRCA1/2 mutated patients exposed to AAP or other neoadjuvant hormonal therapies (NHTs) indicated for metastatic castrate resistant prostate cancer (mCRPC).

Study status

Planned
Research institutions and networks

Institutions

Contact details

Dina Gifkins

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Johnson and Johnson
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)