Overview

This trial is active, not recruiting.

Condition gastric cancer
Treatment ramucirumab
Phase phase 2
Target VEGF
Sponsor Eli Lilly and Company
Start date December 2013
End date January 2015
Trial size 33 participants
Trial identifier NCT01983878, 15045, I4T-JE-JVCL

Summary

The purpose of this study is to evaluate progression-free survival in participants with gastric or gastroesophageal junction cancer who have had disease progression following first-line therapy who undergo treatment with ramucirumab.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment will continue until there is evidence of PD, the development of unacceptable toxicity, protocol non compliance or withdrawal of consent.
ramucirumab LY3009806
Administered IV

Primary Outcomes

Measure
Progression Free Survival (PFS) Rate at 12 Weeks
time frame: 12 Weeks

Secondary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Baseline to Measured Progressive Disease (PD) or Death from Any Cause (Estimated up to 12 Months)
Proportion of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
time frame: Baseline to Measured PD or Death from Any Cause (Estimated up to 12 Months)
Percentage of Participants Achieving Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate [DCR])
time frame: Baseline to Measured PD or Death from Any Cause (Estimated up to 12 Months)
Overall Survival (OS)
time frame: Baseline to Death from Any Cause (Estimated up to 12 Months)
Number of Participants with Anti-Ramucirumab Antibodies
time frame: Baseline to 30 day Follow Up (Estimated up to 12 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab
time frame: Cycle 1 Predose up to Cycle 2 Predose
PK: Area Under the Curve (AUC) of Ramucirumab
time frame: Cycle 1 Predose up to Cycle 2 Predose

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Histologically or cytologically confirmed gastric carcinoma, including gastric adenocarcinoma or Gastroesophageal Junction (GEJ) adenocarcinoma - Metastatic disease or locally recurrent, unresectable disease - Measurable disease and/or evaluable disease - Experienced disease progression during or within 4 months after the last dose of first-line therapy for metastatic disease, or during or within 6 months after the last dose of adjuvant therapy - Life expectancy of at least 3 months - Resolution to Grade less than or equal to 1 by the National Cancer Institute Common Terminology Criteria for Adverse , Version 4.03, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy - Eastern Cooperative Oncology Group performance status score of 0-1 - Has adequate organ function - Must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods), if sexually active - Female participants of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment Exclusion Criteria: - Documented and/or symptomatic brain or leptomeningeal metastases - Bone metastases - Experienced Grade 3/4 gastrointestinal (GI) bleeding within 3 months prior to enrollment - Experienced any arterial thromboembolic event within 6 months prior to enrollment - Ongoing or active significant infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, uncontrolled thromboembolic or hemorrhagic disorder, or any other serious uncontrolled medical disorders in the opinion of the investigator - Ongoing or active psychiatric illness or social situation that would limit compliance with study requirements - Blood pressure in abnormal range despite standard medical management - Has a serious or nonhealing wound, ulcer, or bone fracture - Received chemotherapy, radiotherapy, immunotherapy, or targeted therapy for gastric cancer - Received any investigational therapy within 30 days prior to enrollment - Undergone major surgery within 28 days prior to enrollment, or subcutaneous venous access device placement within 7 days prior to enrollment - Received prior therapy with an agent that directly inhibits vascular endothelial growth factor (VEGF) or vascular endothelial growth factor receptor 2 (VEGFR-2) activity (including bevacizumab), or any anti-angiogenic agent - Receiving chronic therapy with nonsteroidal anti-inflammatory drugs or receiving other antiplatelet agents. Aspirin use at doses up to 325 milligrams per day is permitted - Has elective or planned major surgery to be performed during the course of the clinical study - Has a known allergy to any of the treatment components - Pregnant or breastfeeding - Have positive test results for human immunodeficiency virus, hepatitis B, or hepatitis C antibodies - Known alcohol or drug dependency - Previous or concurrent malignancy except for basal or squamous cell skin cancer (nonmelanoma) and/or pre-invasive carcinoma of the cervix, mucosal gastrointestinal or uterine carcinoma, or other solid tumors treated curatively and without evidence of recurrence for at least 3 years prior to enrollment - Currently enrolled in a clinical trial involving an investigational product or non-approved use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study

Additional Information

Official title A Phase 2 Study of Ramucirumab in the Treatment of Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Following Disease Progression on First Line Platinum- or Fluoropyrimidine-Containing Combination Therapy in Japanese Patients
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.