Study identification

PURI

https://redirect.ema.europa.eu/resource/46805

EU PAS number

EUPAS9400

Study ID

46805

Official title and acronym

Safety and Effectiveness of Ramucirumab in Patients with Advanced Gastric Cancer in the European Union and North America: A Prospective Observational Registry (I4T-MC-JVDD)

DARWIN EU® study

No

Study countries

Austria
Belgium
France
Germany
Italy
Spain
Switzerland
United States

Study description

This is a prospective, non-interventional, non-comparative, observational cohort study / registry in the EU and North America. The overall study objective is to evaluate the safety and effectiveness of ramucirumab administered as monotherapy or in combination therapy for second-line treatment of adult patients with advanced gastric cancer under real-world disease conditions.

Study status

Finalised
Research institutions and networks

Institutions

Quintiles
First published:
01/02/2024
Institution

Contact details

Yu-Jing Huang

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of interim report, if expected

Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company
Study protocol
Initial protocol
English (537.58 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)