A Prospective Post-Marketing Observational Safety Study of Cyramza® (Ramucirumab) in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma in China (I4T-MC-B012)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47677
• EU PAS number:
  EUPAS47676
• Study ID:
  47677
• Official title and acronym:
  A Prospective Post-Marketing Observational Safety Study of Cyramza® (Ramucirumab) in Patients with Gastric or Gastroesophageal Junction Adenocarcinoma in China (I4T-MC-B012)
• DARWIN EU® study:
  No
• Study countries:
  China
• Study status:
  Planned

Research institutions and networks

Institutions

Harbin Medical University Cancer Hospital

Study timelines

Date when funding contract was signed

Planned: 30/06/2022

Study start date

Planned: 31/12/2022

Date of final study report

Planned: 31/03/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only