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

Lilly

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Biological: Ramucirumab (IMC-1211B) DP; Drug: Paclitaxel; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01170663

CP12-0922 (Other Identifier)

2010-020426-18 (EudraCT Number)

I4T-IE-JVBE (Other Identifier)

13894

Details and patient eligibility

About

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.

Full description

The aim of this study is to determine if paclitaxel given together with ramucirumab (IMC-1211B) as second line therapy will prolong overall survival (OS) compared to paclitaxel alone.

Approximately 663 participants (at least 18 years) in approximately 200 study centers and in approximately 30 countries will be randomized with histologically or cytologically confirmed metastatic gastric or gastroesophageal junction adenocarcinoma. Participants must have received at least one cycle of first line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) and must have discontinued this therapy prior to study entry due to disease progression.

Upon registration and completion of screening procedure and reviewing the Inclusion and Exclusion Criteria eligible participants will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo.

Ramucirumab (IMC-1211B) DP/placebo will be administered IV on Days 1 and 15, paclitaxel will be administered IV on Days 1, 8 and 15 of a 4 weekly cycle.

Participants will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.

Enrollment: 665 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

665 participants in 2 patient groups, including a placebo group

Ramucirumab (IMC-1211B) Drug Product (DP) and Paclitaxel

Experimental group

Description:

Ramucirumab (IMC-1211B) DP and Paclitaxel

Treatment:

Drug: Paclitaxel

Biological: Ramucirumab (IMC-1211B) DP

Placebo and Paclitaxel

Placebo Comparator group

Description:

Placebo and Paclitaxel

Treatment:

Drug: Placebo

Drug: Paclitaxel