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

NCT02069041 | Completed Phase 1 Results

• 2 other identifiers: 15233I4T-CR-JVCQ
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Carcinoma, Hepatocellular

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline through study completion (Up To 8 Months)

Secondary Outcomes (4)

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

  Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hours

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

  Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hours

• Number of Participants With Anti-Ramucirumab Antibodies

  Baseline through 6.1 Months

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

  Response to Disease Progression or Death (Up To 7 Months)

Study Arms (1)

Ramucirumab + FOLFOX4

EXPERIMENTAL

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.

Biological: Ramucirumab; Drug: FOLFOX4

Interventions

Ramucirumab BIOLOGICAL

Administered IV.

Also known as: IMC-1121B, LY3009806

Ramucirumab + FOLFOX4

FOLFOX4 DRUG

Administered IV.

Also known as: FOLFOX4 (leucovorin + fluorouracil + oxaliplatin)

Ramucirumab + FOLFOX4

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tainan, 70403, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taipei, 10048, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taoyuan, 33305, Taiwan

Location

Related Publications (1)

• Lin CC, Yang TS, Yen CJ, Cheng R, Liu J, Hsu C. Safety and Preliminary Efficacy of Ramucirumab in Combination with FOLFOX4 in Patients with Advanced Hepatocellular Carcinoma: A Nonrandomized, Open-Label, Phase Ib Study. Oncologist. 2020 Dec;25(12):e1921-e1929. doi: 10.1002/onco.13550. Epub 2020 Oct 31.

  PMID: 33017497 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Ramucirumab; Folfox protocol; Leucovorin; Fluorouracil; Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2014
• First Posted: February 21, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 21, 2018
• Results First Posted: November 21, 2018

Record last verified: 2017-09

Locations

TW (3)