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

NCT01140347 | Completed Phase 3 Results DMC

• 4 other identifiers: 13895CP12-0919I4T-IE-JVBF2010-019318-26
• Study Type: interventional
• Target: 565
• Locations: 26 countries
• Sites: 142

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma (HCC); recombinant human immunoglobulin G; subclass 1 (IgG1) monoclonal antibody (MAb); Hepatocellular Carcinoma (HCC) following First-Line Therapy With Sorafenib

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  Randomization to death from any cause (up to 37 months)

Secondary Outcomes (10)

• Progression-Free Survival (PFS)

  Randomization to PD (up to 36 months)

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

  Baseline to the date of first evidence of confirmed CR or PR (up to 37 months)

• Time to Radiographic Progression (TTP)

  Randomization to PD (up to 36 months)

• Change From Baseline in the Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)

  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)

• Change From Baseline in European Quality of Life Questionnaire-5 Dimensions (EQ-5D) Health State Score

  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)

Study Arms (2)

Ramucirumab DP and BSC

EXPERIMENTAL

Biological: Ramucirumab DP (IMC-1121B); Other: BSC

Placebo and BSC

PLACEBO COMPARATOR

Biological: Placebo; Other: BSC

Interventions

Placebo BIOLOGICAL

8 mg/kg IV every 2 weeks

Placebo and BSC

Ramucirumab DP (IMC-1121B) BIOLOGICAL

8 milligrams/kilogram (mg/kg) intravenous (IV) every 2 weeks

Also known as: IMC-1121B, LY3009806

Ramucirumab DP and BSC

BSC OTHER

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 and BSC; Ramucirumab DP and BSC

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (146)

ImClone Investigational Site

Orange, California, 92868, United States

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San Francisco, California, 94115, United States

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New Haven, Connecticut, 06520, United States

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Jacksonville, Florida, 32207, United States

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New Orleans, Louisiana, 70112, United States

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Boston, Massachusetts, 02111, United States

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Worcester, Massachusetts, 01655, United States

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Ann Arbor, Michigan, 48109, United States

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St Louis, Missouri, 63110, United States

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Newark, New Jersey, 07103, United States

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New York, New York, 10029, United States

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Winston-Salem, North Carolina, 27157, United States

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Dayton, Ohio, 45420, United States

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Philadelphia, Pennsylvania, 19141, United States

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Charleston, South Carolina, 29414, United States

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Lubbock, Texas, 79415, United States

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Seattle, Washington, 98109, United States

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Milwaukee, Wisconsin, 53226, United States

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Bankstown, New South Wales, 2200, Australia

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Kogarah, New South Wales, 2217, Australia

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Liverpool Bc, New South Wales, 1871, Australia

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Kurralta Park, South Australia, 5037, Australia

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Prahran, Victoria, 3181, Australia

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Linz, 4021, Austria

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Salzburg, 5020, Austria

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Steyr, 4400, Austria

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Vienna, A1090, Austria

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Bonheiden, 2820, Belgium

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Brussels, 01200, Belgium

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Charleroi, 6000, Belgium

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Edegem, 2650, Belgium

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Leuven, 03000, Belgium

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Liège, 4000, Belgium

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Ottignies, 1340, Belgium

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Belo Horizonte, 30110090, Brazil

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Botucatu, 18618-970, Brazil

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Brasília, 72115-700, Brazil

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Campinas, 13083-970, Brazil

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Ijuí, 98700 000, Brazil

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Ribeirão Preto, 14049-900, Brazil

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Rio de Janeiro, 21941-31, Brazil

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Salvador, 41825-010, Brazil

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Sao Jose Rio Preto, 15090-000, Brazil

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São Paulo, 04039-901, Brazil

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Plovdiv, 4004, Bulgaria

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Sofia, 1527, Bulgaria

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Varna, 9010, Bulgaria

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Ottawa, Ontario, K1H 8L6, Canada

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Brib, 656 53, Czechia

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Hradec Králové, 500 05, Czechia

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Olomouc, 775 20, Czechia

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Prague, 150 06, Czechia

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Helsinki, 180, Finland

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Amiens, 80054, France

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Angers, 49933, France

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Avignon, 84000, France

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Besançon, 25020, France

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Bordeaux, 33000, France

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Clermont-Ferrand, 63003, France

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La Roche-sur-Yon, 85925, France

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Limoges, 87042, France

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Marseille, 13385, France

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Nice, 06200, France

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Paris, 75674, France

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Poitiers, 86021, France

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Reims, 51092, France

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Saint-Etienne, 42055, France

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Berlin, 12203, Germany

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Bielefeld, 33611, Germany

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Bonn, 53105, Germany

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Düsseldorf, 40225, Germany

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Essen, 45122, Germany

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Frankfurt, 60596, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 20246, Germany

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Hanover, 30625, Germany

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Homburg, 66421, Germany

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Leipzig, 04103, Germany

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Magdeburg, 39120, Germany

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Munich, 81377, Germany

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Münster, 48149, Germany

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Tübingen, 72076, Germany

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Ulm, 89081, Germany

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Weiden, 92637, Germany

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Kowloon, Hong Kong

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Pokfulam, Hong Kong

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Shatin, Hong Kong

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Budapest, 1122, Hungary

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Beersheba, 84101, Israel

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Petah Tikva, 49100, Israel

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Tel Aviv, 64239, Israel

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Bari, 70124, Italy

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Benevento, 82100, Italy

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Bologna, 40100, Italy

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Genova, 16132, Italy

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Lecce, 73100, Italy

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Milan, 20122, Italy

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Modena, 41100, Italy

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Padua, 35128, Italy

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Palermo, 90127, Italy

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Pavia, 27100, Italy

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Rome, 00168, Italy

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Udine, 33100, Italy

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Chiba, 260-8677, Japan

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Fukuoka, 810-8563, Japan

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Hyōgo, 650-0046, Japan

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Ishikawa, 920-8641, Japan

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Kanagawa, 241-0815, Japan

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Kochi, 781-8555, Japan

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Kyoto, 606-8397, Japan

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Miyagi, 983-8520, Japan

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Osaka, 565-0871, Japan

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Osaka-Pref, 589, Japan

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Saga, 840, Japan

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Tochigi, 329-0498, Japan

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Tokushima, 770-8503, Japan

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Tokyo, 181-8611, Japan

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Amsterdam, 1105 AZ, Netherlands

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Rotterdam, 3000 CA, Netherlands

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Oslo, 0407, Norway

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Quezon City, 1102, Philippines

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Lisbon, 1649-035, Portugal

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Santa Maria da Feira, 4520-211, Portugal

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Bucharest, 022328, Romania

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Cluj-Napoca, 3400, Romania

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Craiova, 200535, Romania

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Anyang, 431-070, South Korea

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Incheon, 405-760, South Korea

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Seodaemun-Gu, 120-752, South Korea

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Seoul, 135-710, South Korea

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Ávila, 05004, Spain

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Girona, 17007, Spain

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Madrid, 28041, Spain

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Ourense, 320004, Spain

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Valencia, 46014, Spain

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Stockholm, 14186, Sweden

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Bern, CH-3010, Switzerland

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Changhua, 500, Taiwan

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Kuei Shan Hsiang, 33305, Taiwan

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Liouying/Tainan, 736, Taiwan

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Niaosung, 883, Taiwan

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Taichung, 404, Taiwan

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Tainan, 70403, Taiwan

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Taipei, 112, Taiwan

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Bangkok, 10700, Thailand

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Hat Yai, 90110, Thailand

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MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Ramucirumab

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

Results Point of Contact

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

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: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 9, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2015
• Last Updated: December 28, 2015
• Results First Posted: March 26, 2015

Record last verified: 2015-11

Locations

PT (2); TH (2); JP (14); FI (1); IL (3); AU (5); BR (10); US (18); HU (1); DE (17); IT (12); NL (2); FR (14); PH (1); RO (3); BE (7); BU (3); NO (1); CA (1); KR (4); ES (5); CZ (4); SE (1); CH (1); TW (7); HK (3)