A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared to paclitaxel plus placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel; Ramucirumab

Criteria

Inclusion Criteria:

• Signed informed consent

• histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma

• Metastatic disease or locally advanced, unresectable disease

• Disease progression during or within 4 months after the last dose of the first-line therapy (platinum/fluoropyrimidine doublet with or without anthracycline)

• Organs are functioning well (liver, kidney, blood)

• Good performance status Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 to 1

Exclusion Criteria:

• First line chemotherapy for metastatic gastric cancer other than platinum/fluoropyrimidine doublet with or without anthracycline

• Previous systemic therapy with other anti-angiogenic drugs

• Uncontrolled high blood pressure

• Symptomatic or poorly controlled heart disease or had a heart attack or stroke within the last 6 month

• Evidence of central nervous system (CNS) metastasis at baseline