Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Liver Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Micronutrients

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Vitamins

Leucovorin

Fluorouracil

Levoleucovorin

Oxaliplatin

Folic Acid

Liver Extracts

Ramucirumab

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Vitamin B Complex

Trace Elements

Angiogenesis Inhibitors

Growth Inhibitors

Folinic Acid

Folate

Vitamin B9

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.

FOLFOX4

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

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.

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

Phase 1b Study of 5-FU/FA and Oxaliplatin (FOLFOX4) Plus Ramucirumab (LY3009806) in Patients With Advanced Hepatocellular Carcinoma

A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version\[v\] 1.1) criteria.CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size \[\<10 millimeter (mm) short axis\]. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease(PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Percentage of participants with CR or PR= (number of participants whose best overall response was CR or PR)/(number of participants treated)\*100.

Eli Lilly and Company

All participants who received at least one dose of study drug.

Ramucirumab + FOLFOX4

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Taiwan

Region of Enrollment

Histopathological

Cytological

Biochemical Assay and Imaging

All participants who received at least one dose of study drug and had baseline initial pathological diagnosis data.

Basis of Initial Pathological Diagnosis

Stage I

Stage II

Stage III

Stage IV

Unknown

Stage means how big the tumor is and how far it has spread. Stages range from I (spread to nearby tissue) to IV (spread throughout the body).

All participants who received at least one dose of study drug and had baseline disease stage data.

Disease Stage

Duration of disease is time from date of histology/cytologic confirmation of advanced solid tumor to date of first dose.

All participants who received at least one dose of study drug and had baseline duration of disease data.

Duration of Disease (months)

Missing

Following are ECOG grades. 0: Fully active, perform all pre-disease activities without restriction. 1: Restricted in physically strenuous activity but ambulatory, carry out work of a light or sedentary nature. 2: Ambulatory, capable of selfcare, unable to carry out any work activities, up and about more than (\>) 50% of waking hours. 3: Capable of limited selfcare, confined to bed or chair \>50% of waking hours. 4: Completely disabled, not capable of any selfcare, totally confined to bed or chair. 5: Dead. Participants in "Not reported" category were on study, had no data for this time point.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Stage A

Stage B

Stage C

Stage D

The following is BCLC classification:

Stage A: Early hepatocellular carcinoma. Stage B: Intermediate hepatocellular carcinoma. Stage C: Advanced hepatocellular carcinoma. Stage D: End stage hepatocellular carcinoma.

Barcelona Clinic Liver Cancer (BCLC) Classification

Test Positive

Test Negative

Viral hepatitis B

Chief Medical Officer

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Cycle 1

Cycle 3

All participants who received at least one dose of study drug and had evaluable PK data.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab

PK:Area Under the Concentration-Time Curve (AUC[0-∞]) of Ramucirumab

Number of Participants With Anti-Ramucirumab Antibodies

Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

Overall Study

Spots Global Cancer Trial Database for A Study of Ramucirumab (LY3009806) in Participants With Advanced Liver Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial