A Randomized, Multicenter, Double-Bind, 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 - RAINBOW

Phase 1

• Conditions: Metastatic gastric or gastroesophageal adenocarcinoma; MedDRA version: 9.1Level: LLTClassification code 10053548

• Registration Number: EUCTR2010-020426-18-IT
• Lead Sponsor: IMCLONE LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-02
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 663

Inclusion Criteria

The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing. 2. The patient is at least 18 years of age. 3. The patient has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 at study entry. 4. The patient has a histopathologically or cytologically confirmed diagnosis of gastric or gastroesophageal adenocarcinoma. 5. The patient has metastatic disease or locally advanced, unresectable disease. 6. The patient has experienced documented objective radiographic, clinical, or pathologic (ie, by histology and/or cytology) disease progression during first-line therapy, or within 4 months after the last dose of first-line therapy with any platinum/fluoropyrimidine doublet with or without anthracycline (epirubicin or doxorubicin) for unresectable or metastatic disease.Per l`elenco completo dei criteri di inclusione si prega di fare riferimento al Protocollo versione 1.1 del 08 Luglio 2010.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The patient has squamous cell or undifferentiated gastric cancer. 2. The patient has undergone major surgery within 28 days prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization. 3. The patient has received any chemotherapy other than platinum and fluoropyrimidine with or without anthracycline for gastric adenocarcinoma. 4. The patient has received previous systemic chemotherapy with a cumulative dose of > 900 mg/m2 of epirubicin or > 400 mg/m2 of doxorubicin. 5. The patient has received any previous systemic therapy (including investigational agents) targeting VEGF or the VEGFR signaling pathways. Other previous targeted therapies are permitted, if stopped at least 28 days prior to randomization. Per l`elenco completo dei criteri di esclusione si prega di fare riferimento al Protocollo versione 1.1 del 08 Luglio 2010.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified