A Study of Ramucirumab (LY3009806) in Participants With Advanced Liver Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-09-30

Brief Summary

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The main purpose of this study is to determine if the advised dose of ramucirumab is safe to be taken with chemotherapy treatment in participants with advanced liver tumors.

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ramucirumab + FOLFOX4

8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles:

FOLFOX4 every 2 weeks:

85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2

Participants may continue to receive treatment until discontinuation criteria are met.

Group Type EXPERIMENTAL

Ramucirumab

Intervention Type BIOLOGICAL

Administered IV.

FOLFOX4

Intervention Type DRUG

Administered IV.

Interventions

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Ramucirumab

Administered IV.

Intervention Type BIOLOGICAL

FOLFOX4

Administered IV.

Intervention Type DRUG

Other Intervention Names

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IMC-1121B LY3009806 FOLFOX4 (leucovorin + fluorouracil + oxaliplatin)

Eligibility Criteria

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Inclusion Criteria

* Histological or cytological diagnosis of hepatocellular carcinoma (HCC) or imaging findings consistent with HCC in a participant with liver cirrhosis and alpha-fetoprotein \> 200 nanogram per milliliter
* At least 1 measurable or non-measurable lesion
* Child-Pugh A
* Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy
* Eastern Cooperative Oncology Group Performance Status of 0 or 1
* Have not received previous systemic therapy for advanced HCC
* Have resolution to Grade ≤1 of all clinically significant toxic effects of prior locoregional therapy
* Adequate organ function including: Absolute neutrophil coun t≥1.5×109/liter (L), hemoglobin ≥9 gram/deciliter, and platelets ≥90×109/L; Total bilirubin level ≤1.5 the upper limit of the normal range (ULN), aspartate transaminase and alanine transaminase ≤5 ULN, albumin \>28 gram/L; Serum creatinine level ≤1.5 ULN; or calculated serum creatinine clearance ≥50 milliliter/minute; International Normalized Ratio≤1.5 and partial thromboplastin time ≤5 seconds above ULN
* The urinary protein is ≤ 1+. If ≥ 2+ proteinuria, the 24-hour urine protein is \<1000 milligram
* An estimated life expectancy of at least 12 weeks

Exclusion Criteria

* Received any investigational therapy or non-approved drug within 28 days prior to enrollment
* Undergone major surgery within 28 days prior to enrollment, or undergone central venous access device placement within 7 days prior to enrollment
* Undergone hepatic locoregional therapy within 28 days prior to enrollment
* Undergone radiation to any nonhepatic site within 14 days prior to enrollment
* Prior liver transplant
* Fibrolamellar carcinoma or cholangiocellular carcinoma
* Received any transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte-colony stimulating factors within 14 days prior to enrollment
* Receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents
* Receiving ongoing therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents.
* Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
* Active or uncontrolled clinically serious infection
* Uncontrolled thrombotic or hemorrhagic disorder
* Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
* History of gastrointestinal perforation or obstruction
* History of or current hepatic encephalopathy or current clinically meaningful ascites
* Known allergy to monoclonal antibody, fluorouracil, oxaliplatin or their excipients
* Interstitial pneumonia or interstitial fibrosis of the lung
* Central nervous system metastases or carcinomatous meningitis
* Known history of dihydropyrimidine dehydrogenase deficiency
* Symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
* Experienced any arterial thromboembolic event
* Uncontrolled arterial hypertension
* Grade 3-4 venous thromboembolic events occurring within 3 months prior to enrollment
* Experienced any grade 3-4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion, endoscopic or operative intervention
* Esophageal or gastric varices that require immediate intervention or represent a high bleeding risk
* Pre-existing grade ≥ 2 motor or sensory neuropathy

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No