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Trial record 2 of 6 for:    LY3009806 hepatocellular

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

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ClinicalTrials.gov Identifier: NCT02069041
Recruitment Status : Completed
First Posted : February 21, 2014
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Biological: Ramucirumab Drug: FOLFOX4 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1b Study of 5-FU/FA and Oxaliplatin (FOLFOX4) Plus Ramucirumab (LY3009806) in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : April 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ramucirumab + FOLFOX4
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. Participants may continue to receive treatment until discontinuation criteria are met.
Biological: Ramucirumab
Administered IV.
Other Names:
  • IMC-1121B
  • LY3009806

Drug: FOLFOX4
Administered IV.
Other Name: FOLFOX4 (leucovorin + fluorouracil + oxaliplatin)




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through study completion (estimated as 8 months) ]

Secondary Outcome Measures :
  1. Pharmacokinetics: Maximum Concentration (Cmax) of Ramucirumab [ Time Frame: Baseline through Cycle 9, Day 1 (Cycle = 2 weeks) ]
  2. Pharmacokinetics: Area Under the Concentration Curve (AUC) of Ramucirumab [ Time Frame: Baseline through Cycle 9, Day 1 (Cycle = 2 weeks) ]
  3. Number of Participants with Anti-Ramucirumab Antibodies [ Time Frame: Baseline through Cycle 9, Day 1 (Cycle = 2 weeks) ]
  4. Objective Responses Rate (ORR) [ Time Frame: Response to disease progression or death (estimated as 2 months) ]


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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02069041


Locations
Taiwan
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, Taiwan, 70403
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, Taiwan, 10048
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 City, Taiwan, 33305
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02069041     History of Changes
Other Study ID Numbers: 15233
I4T-CR-JVCQ ( Other Identifier: Eli Lilly and Company )
First Posted: February 21, 2014    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Oxaliplatin
Ramucirumab
Fluorouracil
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs