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Carcinoma, HepatocellularPhase 2NCT03433703

Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)

A Phase 2 study testing Lenvatinib in people with Carcinoma, Hepatocellular, run by Eisai Inc. at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to assess the safety and tolerability of subsequent systemic treatment of physician's choice (TPC) following the first-line lenvatinib treatment in unresectable hepatocellular carcinoma (uHCC) participants. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Hepatocellular
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
4 sitesUnited States
Study dates
26 Apr 2018to 7 Jan 2019
Phase
Phase 2
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

  • Participants must have confirmed diagnosis of unresectable Hepatocellular Carcinoma (uHCC) with any of the following criteria:
  • Histologically or cytologically confirmed diagnosis of uHCC
  • Clinically confirmed diagnosis of uHCC according to American Association for the Study of Liver Diseases criteria, including cirrhosis of any etiology or with chronic hepatitis B or C infection criteria
  • At least one measurable target lesion regardless if hepatic or non-hepatic according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) meeting the following criteria:
  • Hepatic lesion
  • The lesion can be accurately measured in at least one dimension as ≥1.0 centimeters (cm) (viable tumor for typical; and longest diameter for atypical), and
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  • The lesion is suitable for repeat measurement,
  • Nonhepatic lesion
  • Lymph node lesion that measures at least one dimension as ≥1.5 cm in the short axis
  • Non-nodal lesion that measures ≥1.0 cm in the longest diameter Lesions previously treated with radiotherapy or locoregional therapy must show radiographic evidence of disease progression to be deemed a target lesion.
  • Participants categorized on the Barcelona Clinic Liver Cancer staging system to Stage B (not applicable for transarterial chemoembolization) or Stage C
  • Adequate bone marrow function, liver function, blood coagulation function, renal function, and pancreatic function as assessed by laboratory tests.
  • Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as BP ≤150/90 millimeters of mercury (mmHg) at Screening and no change in antihypertensive therapy within 1 week prior to Cycle 1/Day 1
  • Child-Pugh A
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Survival expectation of 12 weeks or longer before starting study drug

Who cannot join

  • Imaging findings for HCC corresponding to any of the following:
  • HCC with ≥50% liver occupation
  • Clear invasion into the bile duct
  • Portal vein invasion at the main portal branch (Vp4)
  • Participants who have received any systemic chemotherapy, including sorafenib, regorafenib or other anti-vascular endothelial growth factor therapy, nivolumab, or any systemic investigational anticancer agents, including lenvatinib, for advanced/uHCC.
  • Participants who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, e.g., granulocyte colony-stimulating factor) within 28 days prior to the first dose of lenvatinib study treatment.
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  • Participants who have not recovered from toxicities as a result of prior anticancer therapy such as the local hepatic injection chemotherapy or any prior therapy for other cancer types.
  • Significant cardiovascular impairment within 6 months of the first dose of study drug
  • Prolongation of QT interval corrected for heart rate using Fridericia's correction (QTcF) to >480 milliseconds (ms)
  • Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib in the opinion of the investigator
  • Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio monitoring
  • Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least half teaspoon) within 28 days prior to the first dose of lenvatinib study treatment
  • Gastric or esophageal varices that require treatment
  • Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months
  • Any history of or current brain or subdural metastases
  • Participants having >1+ proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥1 grams/24 hour will be ineligible
  • Arterial-portal venous shunt or arterial-venous shunt preventing proper diagnosis of tumor
  • Any medical or other condition that in the opinion of the investigator would preclude the participant's participation in a clinical study
  • Known intolerance to lenvatinib or any of the excipients
  • Human immunodeficiency virus positive or active infection requiring treatment (except for hepatitis virus)
  • Any history of drug or alcohol dependency or abuse within the prior 2 years
  • Major surgery within 3 weeks prior to the first dose of lenvatinib study treatment or scheduled for surgery during the study
  • Participant has had a liver transplant
  • Females who are breastfeeding or pregnant at Screening or Baseline
  • Females of childbearing potential who within 28 days before study entry did not use a highly effective method of contraception or do not agree to use a highly effective method of contraception throughout the entire study period

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Florida

    Gainesville, Florida, 32611

  • University of Louisville

    Louisville, Kentucky, 40202

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • California Liver Research Institute

    Pasadena, California, 91105

Other trials in United States

About this study

Official title: A Single-Arm, Multicenter, Phase 2 Trial to Evaluate Safety and Efficacy of Treatment of Physician Choice (TPC) Following First-Line Treatment of Lenvatinib in Subjects With Unresectable Hepatocellular Carcinoma (uHCC)

The primary objective of this study is to assess the safety and tolerability of subsequent systemic treatment of physician's choice (TPC) following the first-line lenvatinib treatment in unresectable hepatocellular carcinoma (uHCC) participants.

Being tested
Lenvatinib
Keywords
Unresectable hepatocellular carcinoma, Lenvatinib, E7080
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • LenvatinibDrug

    Also called LENVIMA®, E7080

    Lenvatinib capsules will be administered orally, once daily in continuous 28-day cycles.

    Body weight (BW) ≥60 kilograms (kg) - Lenvatinib 12 mg (taken as three 4-mg capsules); BW <60 kg - Lenvatinib 8 mg (taken as two 4-mg capsules)

Study groups in NCT03433703
Study groupRoleWhat they receive
LenvatinibExperimentalParticipants will receive lenvatinib 12 or 8 milligrams (mg) once daily in continuous 28-day cycles until disease progression, development of unacceptable toxicity, participant request, withdrawal of consent, or study termination by the sponsor. Upon completion of lenvatinib treatment, eligible participants will receive commercially available systemic TPC for hepatocellular carcinoma in the subsequent treatment period.
Receives: Drug: Lenvatinib

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 months)

Secondary outcomes (3)

  1. Overall Survival (OS)

    OS is defined as the time from the date of first dose of study treatment to the date of death from any cause. Participants who are lost to follow-up are censored at the last date the participant was known to be alive, and participants who remain alive are censored at the time of data cutoff. OS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.

    Measured: From first dose date until date of death from any cause (approximately 3 months)

  2. Progression-free Survival (PFS)

    PFS based on modified Response Evaluation Criteria in Solid Tumors (mRECIST) (and including the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of PD, or the date of death during the subsequent systemic TPC, whichever occurs first. PD is defined at least 20% increase (including an absolute increase of at least 5 millimeter [mm]) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. PFS was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.

    Measured: From first dose date until PD or date of death from any cause (approximately 3 months)

  3. Time to Progression (TTP)

    TTP based on mRECIST (and including the RECIST 1.1 conventions for non-hepatic lesions) is defined as the time from the date of the first dose of first-line lenvatinib treatment to the date of the first documentation of disease progression during subsequent systemic TPC. PD is defined at least 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. TTP was to be calculated using Kaplan-Meier estimate and presented with 2-sided 95% confidence interval.

    Measured: From first dose date until PD (approximately 3 months)

Timeline

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

  1. First posted14 Feb 2018
  2. Study start26 Apr 2018
  3. Primary completion7 Jan 2019
  4. Study completion7 Jan 2019

Why it stopped: Study recruitment was stopped due to difficulty in enrolling the targeted number of participants.

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 2
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
NCT03433703
Sponsor's protocol ID
E7080-M001-222
Status last verified
Jun 2018
First submitted
9 Feb 2018
Last updated
6 Dec 2019
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Carcinoma, Hepatocellular, run by Eisai Inc. at 4 sites in United States.

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 16 inclusion and 25 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: stopped early, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 6 Dec 2019). 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 Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From the first dose of study drug up to 28 days after the last dose of study drug (approximately 3 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 NCT03433703.

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 6 Dec 2019.

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