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Carcinoma, HepatocellularPhase 1NCT02069041

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

A Phase 1 study testing Ramucirumab and FOLFOX4 in people with Carcinoma, Hepatocellular, run by Eli Lilly and Company at 3 sites in Taiwan.

Completed

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

Official record
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Trial summary

The main purpose of this study is to determine if the advised dose of ramucirumab is safe to be taken with chemotherapy treatment in participants with advanced liver tumors. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Ramucirumab and FOLFOX4
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesTaiwan
Study dates
Apr 2014to Sep 2016
Phase
Phase 1
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 20 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological or cytological diagnosis of hepatocellular carcinoma (HCC) or imaging findings consistent with HCC in a participant with liver cirrhosis and alpha-fetoprotein > 200 nanogram per milliliter
  • At least 1 measurable or non-measurable lesion
  • Child-Pugh A
  • Barcelona Clinic Liver Cancer (BCLC) stage C or BCLC stage B not amenable to locoregional therapy or refractory to locoregional therapy
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Have not received previous systemic therapy for advanced HCC
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  • Have resolution to Grade ≤1 of all clinically significant toxic effects of prior locoregional therapy
  • Adequate organ function including: Absolute neutrophil coun t≥1.5×109/liter (L), hemoglobin ≥9 gram/deciliter, and platelets ≥90×109/L; Total bilirubin level ≤1.5 the upper limit of the normal range (ULN), aspartate transaminase and alanine transaminase ≤5 ULN, albumin >28 gram/L; Serum creatinine level ≤1.5 ULN; or calculated serum creatinine clearance ≥50 milliliter/minute; International Normalized Ratio≤1.5 and partial thromboplastin time ≤5 seconds above ULN
  • The urinary protein is ≤ 1+. If ≥ 2+ proteinuria, the 24-hour urine protein is <1000 milligram
  • An estimated life expectancy of at least 12 weeks

Who cannot join

  • Received any investigational therapy or non-approved drug within 28 days prior to enrollment
  • Undergone major surgery within 28 days prior to enrollment, or undergone central venous access device placement within 7 days prior to enrollment
  • Undergone hepatic locoregional therapy within 28 days prior to enrollment
  • Undergone radiation to any nonhepatic site within 14 days prior to enrollment
  • Prior liver transplant
  • Fibrolamellar carcinoma or cholangiocellular carcinoma
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  • Received any transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte-colony stimulating factors within 14 days prior to enrollment
  • Receiving therapeutic anticoagulation with warfarin, low-molecular weight heparin, or similar agents
  • Receiving ongoing therapy with nonsteroidal anti-inflammatory agents or other antiplatelet agents.
  • Known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
  • Active or uncontrolled clinically serious infection
  • Uncontrolled thrombotic or hemorrhagic disorder
  • Serious or nonhealing wound, ulcer, or bone fracture within 28 days prior to enrollment
  • History of gastrointestinal perforation or obstruction
  • History of or current hepatic encephalopathy or current clinically meaningful ascites
  • Known allergy to monoclonal antibody, fluorouracil, oxaliplatin or their excipients
  • Interstitial pneumonia or interstitial fibrosis of the lung
  • Central nervous system metastases or carcinomatous meningitis
  • Known history of dihydropyrimidine dehydrogenase deficiency
  • Symptomatic congestive heart failure, unstable angina pectoris, or symptomatic or poorly controlled cardiac arrhythmia
  • Experienced any arterial thromboembolic event
  • Uncontrolled arterial hypertension
  • Grade 3-4 venous thromboembolic events occurring within 3 months prior to enrollment
  • Experienced any grade 3-4 gastrointestinal bleeding or any variceal bleeding episode in the 3 months prior to enrollment requiring transfusion, endoscopic or operative intervention
  • Esophageal or gastric varices that require immediate intervention or represent a high bleeding risk
  • Pre-existing grade ≥ 2 motor or sensory neuropathy

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Tainan, 70403

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Taipei, 10048

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

    Taoyuan City, 33305

Other trials in Taiwan

About this study

Official title: Phase 1b Study of 5-FU/FA and Oxaliplatin (FOLFOX4) Plus Ramucirumab (LY3009806) in Patients With Advanced Hepatocellular Carcinoma

The main purpose of this study is to determine if the advised dose of ramucirumab is safe to be taken with chemotherapy treatment in participants with advanced liver tumors.

Being tested
Ramucirumab, FOLFOX4
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • RamucirumabBiological

    Also called IMC-1121B, LY3009806

    Administered IV.

  • FOLFOX4Drug

    Also called FOLFOX4 (leucovorin + fluorouracil + oxaliplatin)

    Administered IV.

Study groups in NCT02069041
Study groupRoleWhat they receive
Ramucirumab + FOLFOX4Experimental8 milligram/kilogram (mg/kg) ramucirumab given intravenously (IV) on Day 1 followed by FOLFOX4 (folinic acid + fluorouracil + oxaliplatin chemotherapy regimen) given IV on Day 1 of 2 week cycles: FOLFOX4 every 2 weeks: 85 milligram per square meter (mg/m²) oxaliplatin IV on Day 1 200 mg/m² folinic acid(FA) IV on days 1 and 2 400 mg/m² 5-FU bolus on days 1 and 2 600 mg/m2 5-FU 22-h continuous infusion on Days 1 and 2 Participants may continue to receive treatment until discontinuation criteria are met.
Receives: Biological: Ramucirumab; Drug: FOLFOX4

What is being measured

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

  1. Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.

    Measured: Baseline through study completion (Up To 8 Months)

Secondary outcomes (4)

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of Ramucirumab

    Maximum Concentration (Cmax)

    Measured: Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hours

  2. PK:Area Under the Concentration-Time Curve (AUC[0-∞]) of Ramucirumab

    Area under the concentration-time curve.

    Measured: Cycle 1 and Cycle 3: 0,1.0,1.5,2.0,3.0,5.0,24.0,48.0,168.0,336.0 hours

  3. Number of Participants With Anti-Ramucirumab Antibodies

    Measured: Baseline through 6.1 Months

  4. Percentage of Participants With Best Response of Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])

    Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version[v] 1.1) criteria.CR was defined as the disappearance of all target and non-target lesions and all target and non-target lymph nodes were non-pathological or normal in size [<10 millimeter (mm) short axis]. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters. Progressive Disease(PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (including the baseline sum if that is the smallest).In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

    Percentage of participants with CR or PR= (number of participants whose best overall response was CR or PR)/(number of participants treated)*100.

    Measured: Response to Disease Progression or Death (Up To 7 Months)

Timeline

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

  1. First posted21 Feb 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionSep 2016
  4. Study completionSep 2016

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02069041
Sponsor's protocol ID
15233
Other IDs
I4T-CR-JVCQ
Status last verified
Sep 2017
First submitted
20 Feb 2014
Last updated
21 Nov 2018
Data monitoring committee
No

Publications

  • Lin CC, Yang TS, Yen CJ, Cheng R, Liu J, Hsu C. Safety and Preliminary Efficacy of Ramucirumab in Combination with FOLFOX4 in Patients with Advanced Hepatocellular Carcinoma: A Nonrandomized, Open-Label, Phase Ib Study. Oncologist. 2020 Dec;25(12):e1921-e1929. doi: 10.1002/onco.13550. Epub 2020 Oct 31.

    PubMed 33017497

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ramucirumab and FOLFOX4 in people with Carcinoma, Hepatocellular, run by Eli Lilly and Company at 3 sites in Taiwan.

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 10 inclusion and 26 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 21 Nov 2018). 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?

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through study completion (Up To 8 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 NCT02069041, which also lists 1 linked publication.

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 21 Nov 2018.

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