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AzTrials

Hepatocellular CarcinomaPhase 3REACHNCT01140347

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

A Phase 3 study testing Ramucirumab DP (IMC-1121B) and BSC in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 146 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Ramucirumab DP (IMC-1121B) and BSC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
565 participants
Where
146 sitesin 27 countries
Study dates
Oct 2010to Mar 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

146 sites in 27 countries.

146 sites in 27 countries

United States18 sites

  • ImClone Investigational Site

    Ann Arbor, Michigan, 48109

  • ImClone Investigational Site

    Boston, Massachusetts, 02111

  • ImClone Investigational Site

    Charleston, South Carolina, 29414

  • ImClone Investigational Site

    Dayton, Ohio, 45420

  • ImClone Investigational Site

    Jacksonville, Florida, 32207

  • ImClone Investigational Site

    Lubbock, Texas, 79415

  • ImClone Investigational Site

    Milwaukee, Wisconsin, 53226

  • ImClone Investigational Site

    New Haven, Connecticut, 06520

  • ImClone Investigational Site

    New Orleans, Louisiana, 70112

  • ImClone Investigational Site

    New York, New York, 10029

  • ImClone Investigational Site

    Newark, New Jersey, 07103

  • ImClone Investigational Site

    Orange, California, 92868

  • ImClone Investigational Site

    Philadelphia, Pennsylvania, 19141

  • ImClone Investigational Site

    San Francisco, California, 94115

  • ImClone Investigational Site

    Seattle, Washington, 98109

  • ImClone Investigational Site

    St Louis, Missouri, 63110

  • ImClone Investigational Site

    Winston-Salem, North Carolina, 27157

  • ImClone Investigational Site

    Worcester, Massachusetts, 01655

Other trials in United States

Germany17 sites

  • ImClone Investigational Site

    Berlin, 12203

  • ImClone Investigational Site

    Bielefeld, 33611

  • ImClone Investigational Site

    Bonn, 53105

  • ImClone Investigational Site

    Düsseldorf, 40225

  • ImClone Investigational Site

    Essen, 45122

  • ImClone Investigational Site

    Frankfurt, 60596

  • ImClone Investigational Site

    Freiburg im Breisgau, 79106

  • ImClone Investigational Site

    Hamburg, 20246

  • ImClone Investigational Site

    Hanover, 30625

  • ImClone Investigational Site

    Homburg, 66421

  • ImClone Investigational Site

    Leipzig, 04103

  • ImClone Investigational Site

    Magdeburg, 39120

  • ImClone Investigational Site

    Munich, 81377

  • ImClone Investigational Site

    Münster, 48149

  • ImClone Investigational Site

    Tübingen, 72076

  • ImClone Investigational Site

    Ulm, 89081

  • ImClone Investigational Site

    Weiden, 92637

Other trials in Germany

France14 sites

  • ImClone Investigational Site

    Amiens, 80054

  • ImClone Investigational Site

    Angers, 49933

  • ImClone Investigational Site

    Avignon, 84000

  • ImClone Investigational Site

    Besançon, 25020

  • ImClone Investigational Site

    Bordeaux, 33000

  • ImClone Investigational Site

    Clermont-Ferrand, 63003

  • ImClone Investigational Site

    La Roche-sur-Yon, 85925

  • ImClone Investigational Site

    Limoges, 87042

  • ImClone Investigational Site

    Marseille, 13385

  • ImClone Investigational Site

    Nice, 06200

  • ImClone Investigational Site

    Paris, 75674

  • ImClone Investigational Site

    Poitiers, 86021

  • ImClone Investigational Site

    Reims, 51092

  • ImClone Investigational Site

    Saint-Etienne, 42055

Other trials in France

Japan14 sites

  • ImClone Investigational Site

    Chiba, 260-8677

  • ImClone Investigational Site

    Fukuoka, 810-8563

  • ImClone Investigational Site

    Hyōgo, 650-0046

  • ImClone Investigational Site

    Ishikawa, 920-8641

  • ImClone Investigational Site

    Kanagawa, 241-0815

  • ImClone Investigational Site

    Kochi, 781-8555

  • ImClone Investigational Site

    Kyoto, 606-8397

  • ImClone Investigational Site

    Miyagi, 983-8520

  • ImClone Investigational Site

    Osaka, 565-0871

  • ImClone Investigational Site

    Osaka-Pref, 589

  • ImClone Investigational Site

    Saga, 840

  • ImClone Investigational Site

    Tochigi, 329-0498

  • ImClone Investigational Site

    Tokushima, 770-8503

  • ImClone Investigational Site

    Tokyo, 181-8611

Other trials in Japan

Italy12 sites

  • ImClone Investigational Site

    Bari, 70124

  • ImClone Investigational Site

    Benevento, 82100

  • ImClone Investigational Site

    Bologna, 40100

  • ImClone Investigational Site

    Genova, 16132

  • ImClone Investigational Site

    Lecce, 73100

  • ImClone Investigational Site

    Milan, 20122

  • ImClone Investigational Site

    Modena, 41100

  • ImClone Investigational Site

    Padova, 35128

  • ImClone Investigational Site

    Palermo, 90127

  • ImClone Investigational Site

    Pavia, 27100

  • ImClone Investigational Site

    Rome, 00168

  • ImClone Investigational Site

    Udine, 33100

Other trials in Italy

Brazil10 sites

  • ImClone Investigational Site

    Belo Horizonte, 30110090

  • ImClone Investigational Site

    Botucatu, 18618-970

  • ImClone Investigational Site

    Brasília, 72115-700

  • ImClone Investigational Site

    Campinas, 13083-970

  • ImClone Investigational Site

    Ijuí, 98700 000

  • ImClone Investigational Site

    Ribeirão Preto, 14049-900

  • ImClone Investigational Site

    Rio de Janeiro, 21941-31

  • ImClone Investigational Site

    Salvador, 41825-010

  • ImClone Investigational Site

    Sao Jose Rio Preto, 15090-000

  • ImClone Investigational Site

    São Paulo, 04039-901

Other trials in Brazil

Belgium7 sites

  • ImClone Investigational Site

    Bonheiden, 2820

  • ImClone Investigational Site

    Brussels, 01200

  • ImClone Investigational Site

    Charleroi, 6000

  • ImClone Investigational Site

    Edegem, 2650

  • ImClone Investigational Site

    Leuven, 03000

  • ImClone Investigational Site

    Liège, 4000

  • ImClone Investigational Site

    Ottignies, 1340

Other trials in Belgium

Taiwan7 sites

  • ImClone Investigational Site

    Changhua, 500

  • ImClone Investigational Site

    Kuei Shan Hsiang, 33305

  • ImClone Investigational Site

    Liouying/Tainan, 736

  • ImClone Investigational Site

    Niaosung, 883

  • ImClone Investigational Site

    Taichung, 404

  • ImClone Investigational Site

    Tainan, 70403

  • ImClone Investigational Site

    Taipei, 112

Other trials in Taiwan

Australia5 sites

  • ImClone Investigational Site

    Bankstown, New South Wales, 2200

  • ImClone Investigational Site

    Kogarah, New South Wales, 2217

  • ImClone Investigational Site

    Kurralta Park, South Australia, 5037

  • ImClone Investigational Site

    Liverpool Bc, New South Wales, 1871

  • ImClone Investigational Site

    Prahran, Victoria, 3181

Other trials in Australia

Spain5 sites

  • ImClone Investigational Site

    Ávila, 05004

  • ImClone Investigational Site

    Girona, 17007

  • ImClone Investigational Site

    Madrid, 28041

  • ImClone Investigational Site

    Ourense, 320004

  • ImClone Investigational Site

    Valencia, 46014

Other trials in Spain

Austria4 sites

  • ImClone Investigational Site

    Linz, 4021

  • ImClone Investigational Site

    Salzburg, 5020

  • ImClone Investigational Site

    Steyr, 4400

  • ImClone Investigational Site

    Vienna, A1090

Other trials in Austria

Czechia4 sites

  • ImClone Investigational Site

    Brib, 656 53

  • ImClone Investigational Site

    Hradec Králové, 500 05

  • ImClone Investigational Site

    Olomouc, 775 20

  • ImClone Investigational Site

    Prague, 150 06

Other trials in Czechia

South Korea4 sites

  • ImClone Investigational Site

    Anyang, 431-070

  • ImClone Investigational Site

    Incheon, 405-760

  • ImClone Investigational Site

    Seodaemun-Gu, 120-752

  • ImClone Investigational Site

    Seoul, 135-710

Other trials in South Korea

Bulgaria3 sites

  • ImClone Investigational Site

    Plovdiv, 4004

  • ImClone Investigational Site

    Sofia, 1527

  • ImClone Investigational Site

    Varna, 9010

Other trials in Bulgaria

Hong Kong3 sites

  • ImClone Investigational Site

    Kowloon

  • ImClone Investigational Site

    Pokfulam

  • ImClone Investigational Site

    Shatin

Other trials in Hong Kong

Israel3 sites

  • ImClone Investigational Site

    Beersheba, 84101

  • ImClone Investigational Site

    Petah Tikva, 49100

  • ImClone Investigational Site

    Tel Aviv, 64239

Other trials in Israel

Romania3 sites

  • ImClone Investigational Site

    Bucharest, 022328

  • ImClone Investigational Site

    Cluj-Napoca, 3400

  • ImClone Investigational Site

    Craiova, 200535

Other trials in Romania

Netherlands2 sites

  • ImClone Investigational Site

    Amsterdam, 1105 AZ

  • ImClone Investigational Site

    Rotterdam, 3000 CA

Other trials in Netherlands

Portugal2 sites

  • ImClone Investigational Site

    Lisbon, 1649-035

  • ImClone Investigational Site

    Santa Maria da Feira, 4520-211

Other trials in Portugal

Thailand2 sites

  • ImClone Investigational Site

    Bangkok, 10700

  • ImClone Investigational Site

    Hat Yai, 90110

Other trials in Thailand

Canada1 site

  • ImClone Investigational Site

    Ottawa, Ontario, K1H 8L6

Other trials in Canada

Finland1 site

  • ImClone Investigational Site

    Helsinki, 180

Other trials in Finland

Hungary1 site

  • ImClone Investigational Site

    Budapest, 1122

Other trials in Hungary

Norway1 site

  • ImClone Investigational Site

    Oslo, 0407

Other trials in Norway

Philippines1 site

  • ImClone Investigational Site

    Quezon City, 1102

Other trials in Philippines

Sweden1 site

  • ImClone Investigational Site

    Stockholm, 14186

Other trials in Sweden

Switzerland1 site

  • ImClone Investigational Site

    Bern, CH-3010

Other trials in Switzerland

About this study

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)

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.

Read more

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.

Being tested
Placebo, Ramucirumab DP (IMC-1121B), BSC
Keywords
Hepatocellular carcinoma (HCC), recombinant human immunoglobulin G, subclass 1 (IgG1) monoclonal antibody (MAb), Hepatocellular Carcinoma (HCC) following First-Line Therapy With Sorafenib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    8 mg/kg IV every 2 weeks

  • Ramucirumab DP (IMC-1121B)Biological

    Also called IMC-1121B, LY3009806

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

  • BSCOther

    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.

Study groups in NCT01140347
Study groupRoleWhat they receive
Ramucirumab DP and BSCExperimentalNot described
Receives: Biological: Ramucirumab DP (IMC-1121B); Other: BSC
Placebo and BSCPlacebo comparatorNot described
Receives: Biological: Placebo; Other: BSC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)

  1. Progression-Free Survival (PFS)

    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.

    Measured: Randomization to PD (up to 36 months)

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

    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.

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

  3. Time to Radiographic Progression (TTP)

    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.

    Measured: Randomization to PD (up to 36 months)

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

    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).

    Measured: 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)

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

    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.

    Measured: 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)

  6. Number of Participants With Adverse Events (AEs) and the Number of Participants Who Died

    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.

    Measured: Baseline to study completion (up to 37 months)

  7. Maximum Concentration (Cmax) of Ramucirumab, Cycle 1

    Measured: 1 hour following the completion of Cycle 1 (14-day cycle) infusion

  8. Cmax of Ramucirumab, Cycle 4

    Measured: 1 hour following completion of Cycle 4 (14-day cycles) infusion

  9. Cmax of Ramucirumab, Cycle 7

    Measured: 1 hour following completion of Cycle 7 (14-day cycles) infusion

  10. Number of Participants With Treatment Emergent Positive Anti-Ramucirumab Response [Serum Anti-Ramucirumab Antibody Assessment (Immunogenicity)]

    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.

    Measured: Prior to treatment and 1 hour post end of infusion for Cycles 1, 4 and 7 (14-day cycles)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionMar 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01140347
Sponsor's protocol ID
13895
Other IDs
CP12-0919, I4T-IE-JVBF, 2010-019318-26
Acronym
REACH
Status last verified
Nov 2015
First submitted
2 Jun 2010
Last updated
28 Dec 2015
Data monitoring committee
Yes

Publications

  • Llovet JM, Singal AG, Villanueva A, Finn RS, Kudo M, Galle PR, Ikeda M, Callies S, McGrath LM, Wang C, Abada P, Widau RC, Gonzalez-Gugel E, Zhu AX. Prognostic and Predictive Factors in Patients with Advanced HCC and Elevated Alpha-Fetoprotein Treated with Ramucirumab in Two Randomized Phase III Trials. Clin Cancer Res. 2022 Jun 1;28(11):2297-2305. doi: 10.1158/1078-0432.CCR-21-4000.

    PubMed 35247922

  • Mitani S, Chen Y, Inoue K, Mori J, Gao L, Long A, Wakabayashi S. Clinical Impact of a Shortened Infusion Duration of Ramucirumab in Japanese Patients -A Model-Based Approach. Gan To Kagaku Ryoho. 2021 Nov;48(11):1381-1387.

    PubMed 34795131

  • Zhu AX, Finn RS, Kang YK, Yen CJ, Galle PR, Llovet JM, Assenat E, Brandi G, Motomura K, Ohno I, Daniele B, Vogel A, Yamashita T, Hsu CH, Gerken G, Bilbruck J, Hsu Y, Liang K, Widau RC, Wang C, Abada P, Kudo M. Serum alpha-fetoprotein and clinical outcomes in patients with advanced hepatocellular carcinoma treated with ramucirumab. Br J Cancer. 2021 Apr;124(8):1388-1397. doi: 10.1038/s41416-021-01260-w. Epub 2021 Feb 3.

    PubMed 33531690

  • Reig M, Galle PR, Kudo M, Finn R, Llovet JM, Metti AL, Schelman WR, Liang K, Wang C, Widau RC, Abada P, Zhu AX. Pattern of progression in advanced hepatocellular carcinoma treated with ramucirumab. Liver Int. 2021 Mar;41(3):598-607. doi: 10.1111/liv.14731. Epub 2020 Dec 5.

    PubMed 33188713

  • Zhu AX, Nipp RD, Finn RS, Galle PR, Llovet JM, Blanc JF, Okusaka T, Chau I, Cella D, Girvan A, Gable J, Bowman L, Wang C, Hsu Y, Abada PB, Kudo M. Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials. ESMO Open. 2020 Aug;5(4):e000797. doi: 10.1136/esmoopen-2020-000797.

    PubMed 32817068

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ramucirumab DP (IMC-1121B) and BSC in people with Hepatocellular Carcinoma, run by Eli Lilly and Company at 146 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Germany, France, Japan, Italy and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (OS) (time frame: Randomization to death from any cause (up to 37 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01140347, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.

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