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 type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RAMUCIRUMAB
• Medical condition to be studied:
  Gastric cancer stage IV

Population studied

• Short description of the study population:
  This study will include a cohort of approximately 600 adult patients from the EU and North America with advanced gastric cancer or GEJ adenocarcinoma whose disease has progressed after prior chemotherapy and who are treated with ramucirumab alone or in combination therapy as second-line therapy under real-world disease conditions. The decision to initiate use of ramucirumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.; ; Inclusion Criteria; [1] Adult patients (age ≥ 18 years at enrolment) with advanced gastric cancer or GEJ adenocarcinoma whose disease has progressed after prior chemotherapy.; [2] Patients who initiate ramucirumab treatment either as a single agent or in combination with chemotherapy.; [3] Patients who have been fully informed and have given written consent to the use of the needed information to be part of the observational study.; ; Exclusion Criteria; [4] Patients who have received more than 1 line of chemotherapy for advanced gastric cancer or GEJ adenocarcinoma.; [5] Patients concurrently participating in any study including administration of any investigational drug (including ramucirumab) or procedure (including; survival follow-up).
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Renal impaired

  Hepatic impaired
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  The overall study objective is to evaluate the safety and effectiveness of ramucirumab under real-world disease conditions in the Europe and North America
• Outcomes:
  To describe the safety 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 in the Europe and North America, To describe the safety profile in the following subgroups: Elderly patients, patients with cardiac comorbidities, hepatic impairment, and renal impairment. To describe the 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 in the Europe and North America
• Data analysis plan:
  This population includes all patients who have given informed consent and received at least 1 dose of ramucirumab alone or in combination therapy as second-line therapy. Adverse events will be collected, coded, and categorized using the Medical Dictionary for Regulatory Activities (MedDRA). For the primary objective (that is safety), a descriptive analysis will be conducted to evaluate the safety of ramucirumab. Categorical measures will be summarised as counts and percentages, while continuous measures will be summarised using mean, median, standard deviation, and range. For effectiveness outcomes, overall survival and progression-free survival, Kaplan-Meier estimates (including curves) will be generated. The median and survival rates at given time points (eg, 3, 6, 9, 12 months) will be computed together with their 95% CIs using the Kaplan-Meier method. Best tumour response, treatment patterns, healthcare resource utilisation, and supportive care will be summarised descriptively

Documents

Study results

I4T-MC-JVDD PASS Final Study Report_Redacted