Gastrointestinal Cancer
Paclitaxel w/wo Ramucirumab in Metastatic Gastric Cancer (UW10036)
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
| Status | Conditions | Phase | Study ID |
| Closed | Gastric Cancer | Phase III |
UW10036 NCT01170663 |
Summary
This is a phase III randomized multicenter double-blind, placebo controlled trial evaluating the safety and efficacy of paclitaxel plus ramucirumab drug product (DP) compared to paclitaxel plus placebo.
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Eligibility Criteria (must meet the following to participate in this study)
- 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 (ECOG 0 to 1)
Exclusions (conditions that would prevent participation in this study)
- 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 CNS metastasis at baseline
Last Updated
October 26, 2012See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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