Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatments ramucirumab dp, placebo, paclitaxel
Phase phase 3
Sponsor Eli Lilly and Company
Start date December 2010
End date July 2013
Trial size 665 participants
Trial identifier NCT01170663, 13894, 2010-020426-18, CP12-0922, I4T-IE-JVBE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Ramucirumab DP and Paclitaxel
ramucirumab dp LY3009806
8 mg/kg I.V. infusion on Days 1 and 15 of every 4-week cycle
paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
(Placebo Comparator)
Placebo and Paclitaxel
placebo
Ramucirumab placebo I.V. infusion on Days 1 and 15 of every 4-week cycle
paclitaxel
Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle

Primary Outcomes

Measure
Overall survival time (OS)
time frame: Approximately 32 months

Secondary Outcomes

Measure
Progression-free survival (PFS)
time frame: Approximately 32 months
Time to progressive disease (TTP)
time frame: Approximately 32 months
Best overall response (BOR)
time frame: Approximately 32 months
Objective response (ORR)
time frame: Approximately 32 months
Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)
time frame: 32 months
Maximum concentration (Cmax) after first ramucirumab infusion
time frame: Day 1
Maximum concentration (Cmax) after 4th ramucirumab infusion
time frame: Approximately week 6 (Cycle 2, Day 15)
Maximum concentration (Cmax) after 7th ramucirumab infusion
time frame: Approximately week 12 (Cycle 4, Day 1)
Minimum concentration (Cmin) prior to first ramucirumab infusion
time frame: within the pretreatment period until Day 1
Minimum concentration (Cmin) prior to 4th ramucirumab infusion
time frame: Approximately week 6 (Cycle 2, Day 15)
Minimum concentration (Cmin) prior to 7th ramucirumab infusion
time frame: Approximately week 12 (Cycle 4, Day 1)
Change in European Organisation for Research and Treatment of Cancer [EORTC] QLQ-C30
time frame: 32 months
Change in EuroQol EQ-5D
time frame: 32 months

Eligibility Criteria

Male or female participants at least 18 years old.

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 (ECOG 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 CNS metastasis at baseline

Additional Information

Official title 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
Description The aim of this study is to determine if paclitaxel given together with ramucirumab as second line therapy will prolong overall survival compared to paclitaxel alone. Approximately 663 patients (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. Patients 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 patients will be randomized to receive either paclitaxel plus ramucirumab or paclitaxel plus placebo. Ramucirumab DP/placebo will be administered i.v. on days 1 and 15 , paclitaxel will be administered i.v. on days 1, 8 and 15 of a 4 weekly cycle. Patients will be continuously treated and monitored until radiographic or symptomatic progression of disease, toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.