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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02435433




Registration number
NCT02435433
Ethics application status
Date submitted
1/05/2015
Date registered
6/05/2015
Date last updated
30/07/2021

Titles & IDs
Public title
A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein
Scientific title
Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Ramucirumab and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein (AFP) Following First-Line Therapy With Sorafenib
Secondary ID [1] 0 0
I4T-MC-JVDE
Secondary ID [2] 0 0
15755
Universal Trial Number (UTN)
Trial acronym
REACH-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ramucirumab
Treatment: Drugs - Placebo

Experimental: Ramucirumab - 8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

Placebo Comparator: Placebo - Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.

Experimental: Open Label Ramucirumab - 8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

Experimental: Ramucirumab ME2 Cohort - 8 mg/kg ramucirumab administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.

Placebo Comparator: Placebo ME2 Cohort - Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.


Treatment: Drugs: Ramucirumab
Administered IV

Treatment: Drugs: Placebo
Administered IV

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
Timepoint [1] 0 0
From Date of Randomization to Death from Any Cause (Up to 28 Months)
Secondary outcome [1] 0 0
Progression Free Survival (PFS) - Progression-free survival is defined as time from the date of randomization to the date of first observation of objective progression or death from any cause. Progressive disease (PD) is referenced as the smallest measurements recorded since the treatment started.
Timepoint [1] 0 0
From Randomization to Objective Progression or Death from Any Cause (Up to 28 Months)
Secondary outcome [2] 0 0
Time to Radiographic Progression - Time to radiographic progression is defined as the time from the date of randomization to the date of first observation of objective progression. Progressive disease (PD) is referenced as the smallest measurements recorded since the treatment started.
Timepoint [2] 0 0
From Randomization to Objective Progression (Up to 28 Months)
Secondary outcome [3] 0 0
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR) - Objective response rate is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is the disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
Timepoint [3] 0 0
From Randomization to Objective Progression (Up to 28 Months)
Secondary outcome [4] 0 0
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) Before 2nd, 4th, 7th, and 10th Infusion - PK Cmin of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.
Timepoint [4] 0 0
Predose, Weeks 2, 6, 12 and 18, Day 1; Up to 3 Days Before Infusion (14-Day Cycles)
Secondary outcome [5] 0 0
PK: Serum Concentration Maximum (Cmax) After 1st, 2nd, 4th, 7th and 10th Ram Infusion - PK Cmax of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.
Timepoint [5] 0 0
Weeks 0, 2, 6, 12 and 18, Day 1; 1 hour to 1.5 hours Post End of Infusion (14 day-Cycles)
Secondary outcome [6] 0 0
Percentage of Participants With Anti-Ramucirumab Antibodies - Percentage of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted).
Timepoint [6] 0 0
Predose Cycle 1: 7 Days prior to First Infusion, Cycle 4: 3 Days Prior to Infusion, Cycle 7 through Follow Up (Up to 28 Months)
Secondary outcome [7] 0 0
Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8) - The FACT Hepatobiliary Symptom Index (FHSI-8) is a instrument with specific focus regarding the most frequent and concerning symptoms experienced by participants with hepatobiliary malignancies, including lack of energy, nausea, pain, weight loss, pain in back, fatigue, jaundice, stomach pain or discomfort. The (FHSI-8) questionnaire was used to assess the time to deterioration of FSHI-8 total score issued from the date of randomization to the first date observing deterioration, with the deterioration threshold defined as a decrease = 3-points from baseline. In case of no deterioration, the participants were censored at the time of the last FSHI-8 item recording. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. Kaplan-Meier method Hazard ratio was used to estimate (Ramucirumab versus Placebo) and 95% Confidence Interval (CI) (Wald) were estimated from un-stratified/stratified Cox model.
Timepoint [7] 0 0
From Randomization to the First Date of Deterioration Observation (= 3-point decrease) (Up to 28 Months)
Secondary outcome [8] 0 0
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire - The EQ-5D-5L is a nonspecific and standardized instrument for use as a measure of self-reported health status (EuroQol Group 1990; Herdman et al. 2011). Participants completed the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D-5L health state scale ranges from 0 to 100 and is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
Timepoint [8] 0 0
From Randomization through End of Study (Up to 28 Months)
Secondary outcome [9] 0 0
Time to Deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) - Time to deterioration in ECOG PS is defined as the time from the date of randomization to the first date observing ECOG PS 2 (ie, deterioration from baseline status of 0 [fully active] or 1 [restricted in physically strenuous activity but ambulatory and able to carry out light work]). Participants without PS deterioration were censored at their last documented assessments of 0 or 1. Assessments included ECOG Performance Status (PS): 2- Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3 -Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4 -Completely disabled, cannot carry on any self-care. Totally confined to bed or chair, 5- Dead.
Timepoint [9] 0 0
From Randomization through First Date of Deterioration Observation (ECOG PS=2) (Up to 28 Months)

Eligibility
Key inclusion criteria
- A diagnosis of HCC based on histopathologic findings, or a diagnosis of cirrhosis and
a tumor with classical HCC imaging characteristics.

- Sorafenib was the only systemic therapy for HCC and was discontinued for disease
progression or intolerance (Main Global and ME2 Cohorts only).

- The participant received =2 prior systemic therapy regimen, excluding prior sorafenib
or chemotherapy, for the treatment of HCC (OLE Cohort only).

- =1 measurable lesion per Response Evaluation Criteria In Solid Tumors (RECIST) Version
1.1 that has not been previously treated with locoregional therapy. A participant with
a lesion(s) that has previously been treated with locoregional therapy is also
eligible, if the lesion has documented progression after locoregional treatment and is
measureable.

- Child-Pugh score <7 (Child-Pugh Class A).

- Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not
amenable to locoregional therapy or refractory to locoregional therapy.

- Baseline AFP =400 nanograms/milliliter.

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

- Resolution of all clinically significant toxic effects of prior therapy.

- Total bilirubin =1.5 times upper limit of normal value (ULN), aspartate transaminase
(AST) and alanine transaminase (ALT) =5 × ULN.

- Creatinine clearance =60 milliliters/minute.

- Urinary protein is =1+ on dipstick or routine urinalysis or 24-hour urine
demonstrating <1 gram of protein.

- Absolute neutrophil count =1.0 × 10^9/Liter, hemoglobin =9 grams/deciliter, and
platelets =75 × 10^9/Liter.

- International Normalized Ratio (INR) =1.5 and a partial thromboplastin time (PTT) =5
seconds above the ULN.

- Surgically sterile, postmenopausal, or compliant with a highly effective contraceptive
method.

- If a woman of childbearing potential, a negative serum pregnancy test prior to
randomization.

- Willing to provide blood for research. The participant has provided signed informed
consent prior to any study specific procedures and is amenable to compliance with
protocol schedules and testing.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.

- Concurrent malignancy. Participants with carcinoma in situ of any origin and
participants with prior malignancies in remission may be eligible with sponsor
approval.

- Previous brain metastases, leptomeningeal disease, or uncontrolled spinal cord
compression.

- History of or current hepatic encephalopathy or clinically meaningful ascites.

- Ongoing or recent hepatorenal syndrome.

- Liver transplant (Main Global and ME2 cohorts only; Participants with prior liver
transplant may be eligible for OLE cohort).

- Hepatic locoregional therapy following prior systemic therapy or within 28 days prior
to randomization.

- Major surgical procedure, traumatic injury, non-healing wound, or peptic ulcer =28
days prior to randomization.

- Received radiation to any nonhepatic (for example, bone) site within 14 days prior to
randomization.

- Placement of a subcutaneous venous access device within 7 days prior to the first dose
of study treatment unless the procedure is judged of low risk of bleeding.

- Enrolled in a clinical trial involving an investigational product or unapproved use of
a drug or in medical research judged not to be scientifically or medically compatible
with this study.

- Discontinued from study treatment from another clinical trial within 28 days prior to
randomization.

- Known allergy to any of the treatment components.

- Uncontrolled hypertension.

- Any arterial thrombotic event, including myocardial infarction, unstable angina,
cerebrovascular accident, or transient ischemic attack, <6 months prior to
randomization.

- Any bleeding episode considered life-threatening, or any Grade 3 or 4 gastrointestinal
bleeding episode in the 3 months prior to randomization requiring intervention.

- Esophageal or gastric varices that require intervention or represent high bleeding
risk. Participants with evidence of portal hypertension or prior bleeding must have
had endoscopic evaluation within 3 months prior to randomization.

- Gastrointestinal perforation or fistulae within 6 months prior to randomization.

- Symptomatic congestive heart failure (New York Heart Association II-IV), unstable
angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia.

- Pregnant or breast-feeding.

- Any medical or psychiatric condition that may increase the risk associated with study
participation or may interfere with the interpretation of study results. Conditions
include but are not limited to:

- Human immunodeficiency virus infection or acquired immunodeficiency
syndrome-related illness.

- Active or uncontrolled clinically serious infection. (Participants with chronic
viral hepatitis are eligible.)

- Ongoing or recent history of drug abuse.

- Uncontrolled hereditary or acquired thrombotic or bleeding disorder.

- Bowel obstruction, history or presence of inflammatory enteropathy or extensive
intestinal resection.

- Therapeutic dose anticoagulation with warfarin, low molecular-weight heparin, or
similar agents.

- Chronic therapy with nonsteroidal anti-inflammatory agents or other anti-platelet
agents. Aspirin at doses up to 100 milligrams/day is permitted.

- The participant received prior immunotherapy and is experiencing or has experienced
any of the following (OLE cohort only):

- Any clinically significant Grade =3 immune-related adverse event (irAE)

- Any grade neurologic or ocular irAE

- Any grade immune-related pneumonitis, cardiomyopathy, or hepatitis

- The participant received prior immunotherapy and at the time of study enrollment,
requires steroids or other immunosuppressive agents (OLE cohort only).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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. - Kurralta Park
Recruitment hospital [2] 0 0
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. - Woodville
Recruitment postcode(s) [1] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [2] 0 0
5011 - Woodville
Recruitment outside Australia
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United States of America
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Massachusetts
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Oklahoma
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Oregon
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Kowloon
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ShaTin
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Tuen Mun
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Israel
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Tel Aviv
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Taiwan
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Taipei city
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Taiwan
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Taoyuan City
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United Kingdom
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Acton
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Bebington
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate the safety and efficacy of ramucirumab in
participants with hepatocellular carcinoma (HCC) and elevated baseline alpha-fetoprotein.
Participants will be randomized to ramucirumab or placebo in a 2:1 ratio (Main Global Cohort
and China Maximized Extended Enrollment [ME2] Cohort). Participants may also receive
ramucirumab if eligible to be enrolled in Open-Label Expansion (OLE) Cohort.
Trial website
https://clinicaltrials.gov/show/NCT02435433
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications