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)

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

Study timelines

Date when funding contract was signed

Planned: 24/02/2015

Actual: 24/02/2015

Study start date

Planned: 15/12/2015

Actual: 09/12/2015

Date of interim report, if expected

Actual: 24/05/2019

Date of final study report

Planned: 15/12/2021

Actual: 10/12/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

RAM JVDD PASS (v2.0)

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)