A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | December 2010 |
| End Date: | February 2017 |
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase 3 Study of Weekly Paclitaxel With or Without Ramucirumab (IMC-1121B) Drug Product in Patients With Metastatic Gastric Adenocarcinoma, Refractory to or Progressive After First-Line Therapy With Platinum and Fluoropyrimidine
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.
the safety and efficacy of paclitaxel plus ramucirumab (IMC-1211B) drug product (DP) compared
to paclitaxel plus placebo.
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.
(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.
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
We found this trial at
14
sites
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