Study identification

PURI

https://redirect.ema.europa.eu/resource/43762

EU PAS number

EUPAS41969

Study ID

43762

Official title and acronym

Observational study evaluating the long-term safety and efficacy of avapritinib in the first-line treatment of patients with platelet-derived growth factor receptor alpha (PDGFRA) D842V-mutated gastrointestinal stromal tumour (GIST)

DARWIN EU® study

No

Study countries

Italy
Netherlands
Spain
United States

Study description

This study protocol concerns a non-interventional observational study evaluating the long-term safety (primary objective) and efficacy (secondary objective) of avapritinib in the first-line treatment of patients with platelet-derived growth factor receptor alpha (PDGFRA) D842V mutated gastrointestinal stromal tumour (GIST), (or following ≤4 months of imatinib treatment). This study is an imposed PASS (category 2) as part of the CMA of avapritinib.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Gerard Hoehn

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Blueprint Medicines Netherlands B.V.
Study protocol
Initial protocol

blu-285-1406 pass protocol v2.0.pdf

English (1.4 MB - PDF)View document
Updated protocol

BLU-285-1406 PASS Protocol v5.0.pdf

English (1.14 MB - 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 2 (specific obligation of marketing authorisation)

Regulatory procedure number

EMEA/H/C/PSP/S/0092.1