Study identification

PURI

https://redirect.ema.europa.eu/resource/44185

EU PAS number

EUPAS29407

Study ID

44185

Official title and acronym

Post-authorization safety study to evaluate the risks of myelodysplastic syndrome/acute myeloid leukemia and second primary malignancies in adult patients with platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer receiving maintenance treatment with ZEJULA® (niraparib) (213705 - Zejula PASS 3000-04-001)

DARWIN EU® study

No

Study countries

Germany
Italy
Netherlands
Spain

Study description

The post-authorization safety study is intended to determine the risk to develop myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) and secondary primary malignancy (SPM) in patients administered niraparib in the routine clinical setting to treat patients suffering from ovarian cancer.

Study status

Ongoing
Research institutions and networks

Institutions

Department für Frauengesundheit

Contact details

GSK Clinical Disclosure Advisor

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

GSK
Study protocol
Initial protocol

Zejula PASS 3000-04-001 Protocol Version 5 Clean_02May19 Signed (005)_AMV

English (848.12 KB - PDF)View document
Updated protocol

Protocol_Amendment_Anonymized

English (569.13 KB - PDF)View document
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)