Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

A Study of Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib (REACH)

This study has been completed.
Information provided by (Responsible Party):
Eli Lilly and Company Identifier:
First received: June 2, 2010
Last updated: November 24, 2015
Last verified: November 2015

This is a Phase 3 multicenter, randomized study evaluating the safety and efficacy of ramucirumab DP plus BSC as a double-blind, placebo-controlled (placebo plus BSC) comparison.

Approximately 544 participants, at least 18 years of age, with Child-Pugh score < 7 and diagnosed with hepatocellular carcinoma will be randomized. Participants must have received sorafenib as first-line systemic treatment for hepatocellular carcinoma (HCC), and must have discontinued sorafenib prior to entering the study.

Hypothesis: This sample size will allow differentiation of the expected increase in median overall survival (OS), from 8 months in the placebo arm to 10.67 months in the ramucirumab arm.

Upon registration and completion of screening procedures, eligible participants with HCC who have disease progression during or following first-line therapy with sorafenib, or were intolerant to this agent, will be randomized to receive either ramucirumab DP or placebo.

The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity, noncompliance or withdrawal of consent by the participant, or investigator decision.

Condition Intervention Phase
Hepatocellular Carcinoma
Biological: Placebo
Biological: Ramucirumab DP (IMC-1121B)
Other: BSC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib (REACH)

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Randomization to death from any cause (up to 37 months) ] [ Designated as safety issue: No ]
    OS was defined as the time from the date of randomization to the date of death from any cause. Participants who were alive at the end of the follow-up period or were lost to follow-up were censored on the last date the participant was known to be alive.

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: Randomization to PD (up to 36 months) ] [ Designated as safety issue: No ]
    PFS was defined as time from date of randomization until date of objectively determined progressive disease (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death from any cause. PD was defined as ≥20% increase in sum of diameters (SOD) of target lesions, taking as reference smallest sum on study (including baseline sum if it was smallest). Sum must show a ≥5 millimeter (mm) increase. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. In primary analysis, participants alive and without PD were censored at day of last adequate tumor assessment; progression or deaths without progression occurring immediately after ≥2 missed tumor assessments, were censored at day of the last adequate tumor assessment prior to missing assessments; participants who began new anticancer therapy were censored at day of the last adequate tumor assessment prior to start of new anticancer therapy.

  • Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] [ Time Frame: Baseline to the date of first evidence of confirmed CR or PR (up to 37 months) ] [ Designated as safety issue: No ]
    ORR was defined, using RECIST v1.1 criteria, as the percentage of participants who achieved a best overall response of CR or PR. CR was defined as the disappearance of all lesions and any intratumor arterial enhancement in target lesions, the normalization of the tumor marker level and all lymph nodes short axis reduced to <10 mm. PR was defined as ≥30% decrease in the SOD of target lesions, including the short axes of any target lymph nodes, taking as reference the baseline SOD of target lesions, no new lesions and stable nontarget lesions. Percentage of participants was calculated as: (number of participants with CR or PR / number of participants randomized) * 100.

  • Time to Radiographic Progression (TTP) [ Time Frame: Randomization to PD (up to 36 months) ] [ Designated as safety issue: No ]
    TTP was defined as the time from randomization to the first radiographically documented PD. PD was defined, using RECIST v1.1 criteria, as ≥20% increase in SOD of target lesions, taking as reference smallest sum on study (including baseline sum if it was the smallest). Sum must show an absolute increase of ≥5 mm. Appearance of ≥1 new lesions and unequivocal progression of existing non-target lesions were considered progression. Participants without PD were censored at the day of the last adequate tumor assessment. Progression occurred immediately after ≥2 missed tumor assessments and were censored at the day of the last adequate tumor assessment prior to the missing assessments. Participants who began new anticancer therapy were censored at the day of their last adequate tumor assessment prior to start of new anticancer therapy.

  • Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) [ Time Frame: Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), and end of treatment (up to 34 months) ] [ Designated as safety issue: No ]
    The FHSI-8 is a self-administered 8-item questionnaire that measures a participant's symptoms in the domains of jaundice, stomach pain/discomfort weight loss, and fatigue. Participants rated each item on a 5-point scale from 0 (not at all) to 4 (very much). Item scores were calculated as outlined in the FACIT manual. FHSI-8 total score was the sum of each item's score with a total score ranging from 0 (highly symptomatic) to 32 (asymptomatic).

  • Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score [ Time Frame: Baseline, Prior to infusion on Day 1 of Cycle 4, Cycle 10, and Cycle 16 (14-day cycles), end of treatment (up to 34 months) ] [ Designated as safety issue: No ]
    The EQ-5D is a self-reported, 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire related to the participant's current health state. Each question was scored using a 3 level scale (no problems, some problems, or extreme problems). EQ-5D health state was defined by combining responses from each of the 5 dimensions into a weighted health-state index score according to the United Kingdom (UK) population based algorithm where 0 = death and 1 = perfect health.

  • Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died [ Time Frame: Baseline to study completion (up to 37 months) ] [ Designated as safety issue: No ]
    The number of participants with serious AEs (SAEs), other non-serious AEs and participants who died. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

  • Maximum Concentration (Cmax) of Ramucirumab, Cycle 1 [ Time Frame: 1 hour following the completion of Cycle 1 (14-day cycle) infusion ] [ Designated as safety issue: No ]
  • Cmax of Ramucirumab, Cycle 4 [ Time Frame: 1 hour following completion of Cycle 4 (14-day cycles) infusion ] [ Designated as safety issue: No ]
  • Cmax of Ramucirumab, Cycle 7 [ Time Frame: 1 hour following completion of Cycle 7 (14-day cycles) infusion ] [ Designated as safety issue: No ]
  • Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)] [ Time Frame: Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles) ] [ Designated as safety issue: No ]
    Participants were considered positive for anti-ramucirumab antibodies [anti-drug antibodies (ADA)] if the post-treatment sample had an increase of at least 4-fold in titer from the pretreatment values. If the pretreatment value was not detected or was not present, a 1:20 post-treatment titer was required to indicate treatment emergence of ADA.

Enrollment: 565
Study Start Date: October 2010
Study Completion Date: March 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ramucirumab DP and BSC Biological: Ramucirumab DP (IMC-1121B)
8 milligrams/kilogram (mg/kg) intravenous (IV) every 2 weeks
Other Names:
  • IMC-1121B
  • LY3009806
Other: BSC
Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
Placebo Comparator: Placebo and BSC Biological: Placebo
8 mg/kg IV every 2 weeks
Other: BSC
Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  • Child-Pugh score of <7 (Child-Pugh Class A only)
  • Barcelona Clinic Liver Cancer (BCLC) Stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy
  • Diagnosis of HCC (excluding fibrolamellar carcinoma) in the absence of histologic or cytologic confirmation
  • There are either clinical, laboratory, or radiographic findings consistent with a diagnosis of liver cirrhosis
  • Has a liver mass measuring at least 2 centimeters (cm) with characteristic vascularization seen on either triphasic computed tomography (CT) scan or magnetic resonance imaging (MRI) with gadolinium
  • At least 1 measurable or evaluable lesion that is viable [that is (i.e.), is vascularized], and has not been previously treated with locoregional therapy. A lesion that has been previously treated will qualify as a measurable or evaluable lesion if there was demonstrable progression following locoregional therapy
  • Previously treated with sorafenib and has discontinued sorafenib treatment at least 14 days prior to randomization. Participants may have experienced:

    • Radiographically documented disease progression during sorafenib therapy or after discontinuation of sorafenib therapy, or
    • Discontinuation of sorafenib due to an adverse drug reaction, despite dose reduction by 1 level and BSC
  • The participant has received sorafenib as the only systemic therapeutic intervention. Any hepatic locoregional therapy that has been administered prior to sorafenib is allowed, but not following sorafenib. Radiation to metastatic sites [for example (e.g.), bone] following sorafenib therapy is permitted.
  • Resolution of clinically significant toxicity of any anti-cancer therapy to Grade ≤1 by the National Cancer Institute Common Terminology Criteria for Adverse Events volume 4.0 (NCI-CTCAE v. 4.0).

Adequate Organ Function defined as:

  • Total bilirubin <3.0 milligrams/deciliter (mg/dL) [51.3 micromole/liter (µmol/L)], aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × upper limit of normal (ULN)
  • Serum creatinine ≤1.2 × ULN or calculated creatinine clearance >50 milliliters/minute (mL/min)
  • Absolute neutrophil count (ANC) ≥1.0 × 10^3/microliter (μL) (1.0 × 10^9/liter (L)]), hemoglobin ≥9 grams/deciliter (g/dL) [5.58 millimoles/liter (mmol/L)], and platelets ≥75 × 10^3/µL (75 × 10^9/L)
  • International Normalized Ratio (INR) ≤1.5 and partial thromboplastin time (PTT) ≤5 seconds above ULN. Participants receiving prophylactic low-dose anticoagulant therapy are eligible provided that INR ≤1.5 and PTT ≤5 seconds above the ULN
  • The participant's urinary protein is ≤1+ on dipstick or routine urinalysis. If urine dipstick or routine analysis indicates ≥2+ proteinuria, then a 24-hour urine must be collected and must demonstrate <1000 milligrams (mg) of protein in 24 hours to allow participation in the study

Exclusion criteria:

  • Major surgery within 28 days prior to randomization, or central venous access device placement within 7 days prior to randomization
  • Hepatic locoregional therapy within 28 days prior to randomization
  • Radiation to any nonhepatic (e.g., bone) site within 14 days prior to randomization
  • Sorafenib within 14 days prior to randomization
  • Received any investigational therapy or non-approved drug within 28 days prior to randomization
  • Received any previous systemic therapy with vascular endothelial growth factor (VEGF) inhibitors or vascular endothelial growth factor receptor (VEGFR) inhibitors (including investigational agents) other than sorafenib for treatment of HCC
  • Fibrolamellar carcinoma
  • Received any transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony-stimulating factors (G-CSF) within 14 days prior to randomization
  • Therapeutic anticoagulation with warfarin, low-molecular-weight heparin, or similar agents. Participants receiving prophylactic, low-dose anticoagulation therapy are eligible provided that the coagulation parameters defined in the inclusion criteria (INR ≤1.5 and PTT ≤5 seconds above the ULN) are met
  • Receiving ongoing therapy with nonsteroidal anti-inflammatory agents (NSAIDs, e.g., indomethacin, ibuprofen, naproxen, nimesulide, celecoxib, etoricoxib, or similar agents) or other antiplatelet agents (e.g., clopidogrel, ticlopidine, prasugrel, dipyridamole, picotamide, indobufen, anagrelide, triflusal). Aspirin (ASA) at doses up to 100 milligrams/day (mg/day) is permitted
  • Symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
  • Any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to randomization
  • Uncontrolled arterial hypertension systolic ≥150 / diastolic ≥90 millimeters of mercury (mm Hg) despite standard medical management
  • Grade 3-4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to randomization requiring transfusion, endoscopic or operative intervention (participants with any bleeding episode considered life-threatening during the 3 months prior to randomization are excluded, regardless of transfusion or intervention status)
  • Esophageal or gastric varices that require immediate intervention (e.g., banding, sclerotherapy) or represent a high bleeding risk. Participants with evidence of portal hypertension (including splenomegaly) or any prior history of variceal bleeding must have had endoscopic evaluation within the 3 months immediately prior to randomization. Participants with evidence of portal hypertension are eligible for study participation if endoscopic evaluation does not indicate esophageal or gastric varices that require immediate intervention or represent a high bleeding risk; however, these eligible participants must receive supportive therapy (e.g., beta blocker therapy) according to institutional standards and clinical guidelines during study participation
  • Central nervous system (CNS) metastases or carcinomatous meningitis
  • History of or current hepatic encephalopathy or current clinically meaningful ascites
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01140347

  Hide Study Locations
United States, California
ImClone Investigational Site
Orange, California, United States, 92868
ImClone Investigational Site
San Francisco, California, United States, 94115
United States, Connecticut
ImClone Investigational Site
New Haven, Connecticut, United States, 06520
United States, Florida
ImClone Investigational Site
Jacksonville, Florida, United States, 32207
United States, Louisiana
ImClone Investigational Site
New Orleans, Louisiana, United States, 70112
United States, Massachusetts
ImClone Investigational Site
Boston, Massachusetts, United States, 02111
ImClone Investigational Site
Worcester, Massachusetts, United States, 01655
United States, Michigan
ImClone Investigational Site
Ann Arbor, Michigan, United States, 48109
United States, Missouri
ImClone Investigational Site
St Louis, Missouri, United States, 63110
United States, New Jersey
ImClone Investigational Site
Newark, New Jersey, United States, 07103
United States, New York
ImClone Investigational Site
New York, New York, United States, 10029
United States, North Carolina
ImClone Investigational Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
ImClone Investigational Site
Dayton, Ohio, United States, 45420
United States, Pennsylvania
ImClone Investigational Site
Philadelphia, Pennsylvania, United States, 19141
United States, South Carolina
ImClone Investigational Site
Charleston, South Carolina, United States, 29414
United States, Texas
ImClone Investigational Site
Lubbock, Texas, United States, 79415
United States, Washington
ImClone Investigational Site
Seattle, Washington, United States, 98109
United States, Wisconsin
ImClone Investigational Site
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
ImClone Investigational Site
Bankstown, New South Wales, Australia, 2200
ImClone Investigational Site
Kogarah, New South Wales, Australia, 2217
ImClone Investigational Site
Liverpool Bc, New South Wales, Australia, 1871
Australia, South Australia
ImClone Investigational Site
Kurralta Park, South Australia, Australia, 5037
Australia, Victoria
ImClone Investigational Site
Prahran, Victoria, Australia, 3181
ImClone Investigational Site
Linz, Austria, 4021
ImClone Investigational Site
Salzburg, Austria, 5020
ImClone Investigational Site
Steyr, Austria, 4400
ImClone Investigational Site
Vienna, Austria, A1090
ImClone Investigational Site
Bonheiden, Belgium, 2820
ImClone Investigational Site
Brussels, Belgium, 01200
ImClone Investigational Site
Charleroi, Belgium, 6000
ImClone Investigational Site
Edegem, Belgium, 2650
ImClone Investigational Site
Leuven, Belgium, 03000
ImClone Investigational Site
Liège, Belgium, 4000
ImClone Investigational Site
Ottignies, Belgium, 1340
ImClone Investigational Site
Belo Horizonte, Brazil, 30110090
ImClone Investigational Site
Botucatu, Brazil, 18618-970
ImClone Investigational Site
Brasilia, Brazil, 72115-700
ImClone Investigational Site
Campinas, Brazil, 13083-970
ImClone Investigational Site
Ijui, Brazil, 98700 000
ImClone Investigational Site
Ribeirao Preto, Brazil, 14049-900
ImClone Investigational Site
Rio De Janeiro, Brazil, 21941-31
ImClone Investigational Site
Salvador, Brazil, 41825-010
ImClone Investigational Site
Sao Jose Rio Preto, Brazil, 15090-000
ImClone Investigational Site
São Paulo, Brazil, 04039-901
ImClone Investigational Site
Plovdiv, Bulgaria, 4004
ImClone Investigational Site
Sofia, Bulgaria, 1527
ImClone Investigational Site
Varna, Bulgaria, 9010
Canada, Ontario
ImClone Investigational Site
Ottawa, Ontario, Canada, K1H 8L6
Czech Republic
ImClone Investigational Site
Brib, Czech Republic, 656 53
ImClone Investigational Site
Hradec Kralove, Czech Republic, 500 05
ImClone Investigational Site
Olomouc, Czech Republic, 775 20
ImClone Investigational Site
Prague, Czech Republic, 150 06
ImClone Investigational Site
Helsinki, Finland, 180
ImClone Investigational Site
Amiens, France, 80054
ImClone Investigational Site
Angers, France, 49933
ImClone Investigational Site
Avignon, France, 84000
ImClone Investigational Site
Besancon, France, 25020
ImClone Investigational Site
Bordeaux, France, 33000
ImClone Investigational Site
Clermont-Ferrand, France, 63003
ImClone Investigational Site
La Roche Sur Yon, France, 85925
ImClone Investigational Site
Limoges, France, 87042
ImClone Investigational Site
Marseille, France, 13385
ImClone Investigational Site
Nice, France, 06200
ImClone Investigational Site
Paris, France, 75674
ImClone Investigational Site
Poitiers, France, 86021
ImClone Investigational Site
Reims, France, 51092
ImClone Investigational Site
Saint-Etienne, France, 42055
ImClone Investigational Site
Berlin, Germany, 12203
ImClone Investigational Site
Bielefeld, Germany, 33611
ImClone Investigational Site
Bonn, Germany, 53105
ImClone Investigational Site
Düsseldorf, Germany, 40225
ImClone Investigational Site
Essen, Germany, 45122
ImClone Investigational Site
Frankfurt, Germany, 60596
ImClone Investigational Site
Freiburg, Germany, 79106
ImClone Investigational Site
Hamburg, Germany, 20246
ImClone Investigational Site
Hannover, Germany, 30625
ImClone Investigational Site
Homburg, Germany, 66421
ImClone Investigational Site
Leipzig, Germany, 04103
ImClone Investigational Site
Magdeburg, Germany, 39120
ImClone Investigational Site
Munich, Germany, 81377
ImClone Investigational Site
Münster, Germany, 48149
ImClone Investigational Site
Tübingen, Germany, 72076
ImClone Investigational Site
Ulm, Germany, 89081
ImClone Investigational Site
Weiden, Germany, 92637
Hong Kong
ImClone Investigational Site
Kowloon, Hong Kong
ImClone Investigational Site
Pokfulam, Hong Kong
ImClone Investigational Site
Shatin, Hong Kong
ImClone Investigational Site
Budapest, Hungary, 1122
ImClone Investigational Site
Beer Sheva, Israel, 84101
ImClone Investigational Site
Petah Tiqva, Israel, 49100
ImClone Investigational Site
Tel Aviv, Israel, 64239
ImClone Investigational Site
Bari, Italy, 70124
ImClone Investigational Site
Benevento, Italy, 82100
ImClone Investigational Site
Bologna, Italy, 40100
ImClone Investigational Site
Genova, Italy, 16132
ImClone Investigational Site
Lecce, Italy, 73100
ImClone Investigational Site
Milano, Italy, 20122
ImClone Investigational Site
Modena, Italy, 41100
ImClone Investigational Site
Padova, Italy, 35128
ImClone Investigational Site
Palermo, Italy, 90127
ImClone Investigational Site
Pavia, Italy, 27100
ImClone Investigational Site
Rome, Italy, 00168
ImClone Investigational Site
Udine, Italy, 33100
ImClone Investigational Site
Chiba, Japan, 260-8677
ImClone Investigational Site
Fukuoka, Japan, 810-8563
ImClone Investigational Site
Hyogo, Japan, 650-0046
ImClone Investigational Site
Ishikawa, Japan, 920-8641
ImClone Investigational Site
Kanagawa, Japan, 241-0815
ImClone Investigational Site
Kochi, Japan, 781-8555
ImClone Investigational Site
Kyoto, Japan, 606-8397
ImClone Investigational Site
Miyagi, Japan, 983-8520
ImClone Investigational Site
Osaka-Pref, Japan, 589
ImClone Investigational Site
Osaka, Japan, 565-0871
ImClone Investigational Site
Saga, Japan, 840
ImClone Investigational Site
Tochigi, Japan, 329-0498
ImClone Investigational Site
Tokushima, Japan, 770-8503
ImClone Investigational Site
Tokyo, Japan, 181-8611
Korea, Republic of
ImClone Investigational Site
Anyang, Korea, Republic of, 431-070
ImClone Investigational Site
Incheon, Korea, Republic of, 405-760
ImClone Investigational Site
Seodaemun-Gu, Korea, Republic of, 120-752
ImClone Investigational Site
Seoul, Korea, Republic of, 135-710
ImClone Investigational Site
Amsterdam, Netherlands, 1105 AZ
ImClone Investigational Site
Rotterdam, Netherlands, 3000 CA
ImClone Investigational Site
Oslo, Norway, 0407
ImClone Investigational Site
Quezon City, Philippines, 1102
ImClone Investigational Site
Lisbon, Portugal, 1649-035
ImClone Investigational Site
Santa Maria Da Feira, Portugal, 4520-211
ImClone Investigational Site
Bucharest, Romania, 022328
ImClone Investigational Site
Cluj-Napoca, Romania, 3400
ImClone Investigational Site
Craiova, Romania, 200535
ImClone Investigational Site
Avila, Spain, 05004
ImClone Investigational Site
Girona, Spain, 17007
ImClone Investigational Site
Madrid, Spain, 28041
ImClone Investigational Site
Ourense, Spain, 320004
ImClone Investigational Site
Valencia, Spain, 46014
ImClone Investigational Site
Stockholm, Sweden, 14186
ImClone Investigational Site
Bern, Switzerland, CH-3010
ImClone Investigational Site
Changhua, Taiwan, 500
ImClone Investigational Site
Kuei Shan Hsiang, Taiwan, 33305
ImClone Investigational Site
Liouying/Tainan, Taiwan, 736
ImClone Investigational Site
Niaosung, Taiwan, 883
ImClone Investigational Site
Taichung, Taiwan, 404
ImClone Investigational Site
Tainan, Taiwan, 70403
ImClone Investigational Site
Taipei, Taiwan, 112
ImClone Investigational Site
Bangkok, Thailand, 10700
ImClone Investigational Site
Hat Yai, Thailand, 90110
Sponsors and Collaborators
Eli Lilly and Company
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
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eli Lilly and Company Identifier: NCT01140347     History of Changes
Other Study ID Numbers: 13895  CP12-0919  I4T-IE-JVBF  2010-019318-26 
Study First Received: June 2, 2010
Results First Received: March 13, 2015
Last Updated: November 24, 2015
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Finland: Finnish Medicines Agency
Germany: Paul-Ehrlich-Institut
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
Indonesia: National Agency of Drug and Food Control
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Japan: Pharmaceuticals and Medical Devices Agency
Malaysia: Ministry of Health
Netherlands: Ministry of Health, Welfare and Sport
New Zealand: Medsafe
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Portugal: National Pharmacy and Medicines Institute
Romania: National Medicines Agency
Singapore: Ministry of Health
Spain: Agencia Española de Medicamentos y Productos Sanitarios
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Switzerland: Swissmedic
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Eli Lilly and Company:
Hepatocellular carcinoma (HCC)
recombinant human immunoglobulin G
subclass 1 (IgG1) monoclonal antibody (MAb)
Hepatocellular Carcinoma (HCC) following First-Line Therapy With Sorafenib

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on December 05, 2016