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

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastric Cancer

In brief

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.

Key facts

Study ID

NCT01170663

Run by

Eli Lilly and Company

People needed

665

Starts

2010-12-01

Expected to finish

2017-02-01

Last updated by the study team

2019-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• ImClone Investigational Site — Los Angeles, California, United States
• ImClone Investigational Site — San Francisco, California, United States
• ImClone Investigational Site — Jacksonville, Florida, United States
• ImClone Investigational Site — Miramar, Florida, United States
• ImClone Investigational Site — Atlanta, Georgia, United States
• ImClone Investigational Site — Honolulu, Hawaii, United States
• ImClone Investigational Site — East Orange, New Jersey, United States
• ImClone Investigational Site — Albuquerque, New Mexico, United States
• ImClone Investigational Site — New York, New York, United States
• ImClone Investigational Site — Chattanooga, Tennessee, United States
• ImClone Investigational Site — Houston, Texas, United States
• ImClone Investigational Site — Seattle, Washington, United States
• ImClone Investigational Site — Buenos Aires, Argentina
• ImClone Investigational Site — Caba, Argentina
• ImClone Investigational Site — Rosario, Argentina
• ImClone Investigational Site — Santa Fe, Argentina
• ImClone Investigational Site — Bankstown, New South Wales, Australia
• ImClone Investigational Site — Kogarah, New South Wales, Australia
• ImClone Investigational Site — Liverpool, New South Wales, Australia
• ImClone Investigational Site — Wollongong, New South Wales, Australia
• ImClone Investigational Site — Southport, Queensland, Australia
• ImClone Investigational Site — Kurralta Park, South Australia, Australia
• ImClone Investigational Site — Coburg, Victoria, Australia
• ImClone Investigational Site — Footscray, Victoria, Australia
• ImClone Investigational Site — Burbank, California, United States

Full record on ClinicalTrials.gov

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