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Hepatocellular CancerPhase 1NCT00997022

Trial of Sorafenib in Hepatocellular Cancer (HCC) Transplant Patients

A Phase 1 study testing Sorafenib in people with Hepatocellular Cancer, run by Columbia University at 3 sites in United States.

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

This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib for 6 months. Safety and effectiveness on the post transplant, high risk HCC patients will be studied. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Cancer
What is being tested?
Sorafenib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
3 sitesUnited States
Study dates
May 2009to May 2015
Phase
Phase 1
Are there results?
None posted in the registry

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

  • Age ≥18 years old
  • ECOG Performance Status 0-2
  • Post liver transplant and have explants with histologically confirmed hepatocellular carcinoma.
  • No evidence of HCC disease at study entry by imaging
  • Eligible to start 4 weeks post transplant (29 days post transplant) as long as they are on stable doses of immunosuppressants.
  • "High risk" for recurrence after transplantation
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  • Received prior surgical resection, chemoembolization or other local therapy prior to transplant.
  • Have Child-Pugh Class A or compensated Child-Pugh Class B liver dysfunction at the start of therapy
  • Have adequate bone marrow, liver and renal function as assessed by the following:
  • Hemoglobin ≥ 8.0 g/dl
  • Absolute neutrophil count (ANC) ≥ 1,500/mm3
  • Platelet count ≥ 75,000/mm3
  • Total bilirubin ≤ 1.5 times ULN
  • ALT and AST ≤ 5 x ULN
  • Creatinine ≤ 1.5 times ULN
  • Albumin ≥ 2.5 mg/dl
  • Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
  • Exhibit the ability to understand and willingness to sign a written informed consent regarding the study and alternative treatments.
  • INR < 1.5 or a PT/PTT within normal limits.

Who cannot join

  • Cardiac disease: Congestive heart failure > class II NYHA.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension, defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
  • Active clinically serious infection > CTCAE Grade 2.
  • Thromboembolic events such as a cerebrovascular accident (including transient ischemic attacks) within the past 6 months.
  • Any hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.
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  • Serious non-healing wound, ulcer, or bone fracture within 4 weeks of first dose of study drug.
  • Evidence or history of bleeding diathesis or coagulopathy within 4 weeks of first dose of study drug.
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Use of St. John's Wort or rifampin within 4 weeks of first dose of study drug.
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • Any condition that impairs patient's ability to swallow whole pills.
  • Patients who are pregnant or breastfeeding. Breastfeeding should be discontinued if the patient is to be treated.
  • Prior malignancy treated during the prior 5-years (other than localized non-melanoma carcinoma of the skin).
  • Any condition or social situation that may limit patient's compliance with the study regimen
  • Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis prior to enrollment.
  • Known human immunodeficiency virus (HIV) infection (hepatitis B and hepatitis C infection will not be exclusion criteria.
  • Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Any malabsorption problem which in the investigator's opinion would prevent adequate absorption of the sorafenib.
  • On M-Tor inhibitors

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Southern California

    Los Angeles, California, 90089

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Columbia University Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: Phase I Open-Label, Dose-Finding Study of BAY 43-9006 (Sorafenib) in High-risk Hepatocellular Cancer Patients After Liver Transplantation

This Phase I study of sorafenib in high risk hepatocellular cancer patients after liver transplantation will study 24 subjects for about 5 years. Each subject will receive sorafenib for 6 months. Safety and effectiveness on the post transplant, high risk HCC patients will be studied.

Read the detailed description

Sorafenib (BAY 43-9006) is an oral multi-kinase inhibitor with effects on tumor proliferation and angiogenesis. Sorafenib is approved for the treatment of patients with advanced renal cancer and unresectable hepatocellular carcinoma (HCC). The recommended daily dose of Sorafenib is 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal). Studies of single-agent sorafenib showed treatment was well-tolerated with manageable side effects. The results seen with sorafenib in the Phase III (SHARP) trial suggest that VEGF and RAF kinase inhibition prolong survival in patients with advanced HCC. It is not known whether a drug which is considered primarily cytostatic will be effective in preventing cancer recurrences in the setting of minimal residual disease.

This is a phase I, single center, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) and overall safety profile of daily sorafenib as therapy to prevent HCC recurrence in liver transplant subjects with high-risk HCC. For each subject, the study will consist of two phases: a treatment phase and an extension phase.

Being tested
Sorafenib
Keywords
HCC, High-risk Hepatocellular Cancer
Medical subject headings
Liver Neoplasms

What participants receive

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

  • SorafenibDrug

    Also called Nexavar

    Dose escalation:

    Dose level 1: 200mg of sorafenib daily

    Dose level 2: 200mg of sorafenib BID (twice daily)

    Dose level 3: 200mg QAM (taken every morning) and 400mg QPM (taken every evening)

    Dose level 4: 400mg BID (twice daily)

Study groups in NCT00997022
Study groupRoleWhat they receive
SorafenibExperimentalDaily sorafenib taken orally
Receives: Drug: Sorafenib

What is being measured

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

  1. Maximum tolerated dose of daily sorafenib

    Measured: Every two weeks throughout six cycles

Secondary outcomes (2)

  1. Duration of disease free survival

    Measured: Every three months for 2 years

  2. Duration of progression free survival

    Measured: Every three months for 2 years

Timeline

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

  1. First posted16 Oct 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMay 2015
  4. Study completionMay 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00997022
Sponsor's protocol ID
AAAD3519
Status last verified
Aug 2015
First submitted
14 Oct 2009
Last updated
10 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sorafenib in people with Hepatocellular Cancer, run by Columbia University at 3 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 20 inclusion and 20 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 10 Aug 2015. 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 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum tolerated dose of daily sorafenib (time frame: Every two weeks throughout six cycles). 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 NCT00997022.

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 10 Aug 2015.

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