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Adult Hepatocellular CarcinomaPhase 1NCT01008566

Cixutumumab and Sorafenib Tosylate in Treating Patients With Advanced Liver Cancer

A Phase 1 study testing Cixutumumab, Laboratory Biomarker Analysis and Sorafenib Tosylate in people with Adult Hepatocellular Carcinoma and Advanced Adult Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 6 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 trial is studying the side effects and best dose of cixutumumab when given together with sorafenib tosylate in treating patients with advanced liver cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Cixutumumab, Laboratory Biomarker Analysis and Sorafenib Tosylate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
6 sitesUnited States
Study dates
Aug 2009to May 2016
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 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Unresectable or metastatic HCC for which standard curative measures do not exist; the diagnosis of hepatocellular carcinoma should be based on at least one of the following:
  • The presence of one or more liver lesions, measuring ≥ 2 cm, with characteristic arterial enhancement and venous washout in the setting of liver cirrhosis and/or hepatitis B or C infection
  • The presence of liver lesion(s) with AFP >= 400
  • Tissue confirmation in the absence of a and/or b
  • Tissue availability is desired and will be sought, but tissue availability is not mandated for accrual to the study
  • No prior systemic therapy for HCC; patients may have had prior embolization, chemoembolization, intra-arterial chemotherapy infusion, ethanol injection, radiofrequency ablation or cryosurgery
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  • ECOG 0 or 1
  • Life expectancy of greater than 3 months
  • Absolute neutrophil count > 1,000/mm^3
  • Platelets > 65,000/mm^3
  • Total bilirubin =< 2 x the institutional upper normal limit
  • AST and ALT =< 5 x the institutional upper normal limit
  • Renal function =< 1.5 mg/dl or calculated creatinine clearance > 50 mL/min (Cockcroft-Gault formula)
  • PT < 4 seconds of prolongation above the upper normal limit
  • No evidence of encephalopathy in the last 6 months
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and willing to sign a written informed consent document

Who cannot join

  • Local therapy for HCC within 4 weeks prior to treatment on this study or those who have not recovered from adverse events related to therapy administered more than 4 weeks earlier
  • Receiving other investigational agents
  • Brain metastases, because of their poor prognosis, proclivity for progressive neurologic dysfunction that would confound the evaluation of neurologic adverse events, and the potential for increased risk for CNS adverse events
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated on this clinical trial
  • HIV-positive patients are ineligible
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  • Fasting blood glucose > 160 mg/dL
  • Esophageal or gastric variceal bleeding within the last 6
  • Clinically evident ascites (minimal, medically controlled ascites detectable on imaging studies only is allowed)
  • Child-Pugh C cirrhosis or Child-Pugh B cirrhosis with more than 7 points
  • Patients unable to swallow the sorafenib tablets whole are ineligible; (the tablets cannot be crushed or broken)
  • Cardiac: symptomatic congestive heart failure, unstable angina, clinically significant and uncontrolled cardiac dysrhythmia, uncontrolled hypertension (systolic BP > 150 or diastolic BP > 100 on two occasions within two weeks of beginning therapy on this protocol, myocardial infarction within 6 months, NYHA class > II, LVEF < normal as assessed on MUGA
  • Fibrolamellar carcinoma or any mixed variants of HCC with fibrolamellar histology
  • Hypersensitivity to human IgG unless the patient has subsequently tolerated IgG agents
  • Patients with active hepatitis B infection should be on adequate antiviral therapy

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Penn State Hershey Cancer Institute-Clinical Trials Office

    Hershey, Pennsylvania, 17033-0850

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Pittsburgh Cancer Institute (UPCI)

    Pittsburgh, Pennsylvania, 15232

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: A Phase I Trial of Escalating Doses of the Anti-IGF-1R Monoclonal Antibody IMC-A12 and Standard Dose Sorafenib for Treatment of Advanced Hepatocellular Carcinoma

This phase I trial is studying the side effects and best dose of cixutumumab when given together with sorafenib tosylate in treating patients with advanced liver cancer. Monoclonal antibodies, such as cixutumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cixutumumab together with sorafenib tosylate may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish the maximum tolerated dose (MTD) of IMC-A12 given in conjunction with standard doses of sorafenib to patients with advanced hepatocellular carcinoma (HCC).

II. To describe the toxicity and tolerance of IMC-A12 at each dose studied in combination with standard-dose sorafenib in patients with advanced HCC.

III. To evaluate the impact of IMC-A12 on biomarkers related to the IGF-1R/IGF pathway which is thought relevant to HCC progression and drug resistance.

IV. To obtain preliminary assessments of efficacy through description of progression-free survival (PFS) and objective response rate (RR).

OUTLINE: This is a multicenter, dose-escalation study of cixutumumab followed by an extended accrual phase in which patients are treated at the maximum-tolerated dose.

Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22 and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up periodically.

Being tested
Cixutumumab, Laboratory Biomarker Analysis, Sorafenib Tosylate
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • CixutumumabBiological

    Also called Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12, IMC-A12

    Given IV

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Sorafenib TosylateDrug

    Also called BAY 43-9006 Tosylate, BAY 54-9085, Nexavar, sorafenib

    Given orally

Study groups in NCT01008566
Study groupRoleWhat they receive
Treatment (cixutumumab, sorafenib tosylate)ExperimentalPatients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22 and oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Biological: Cixutumumab; Other: Laboratory Biomarker Analysis; Drug: Sorafenib Tosylate

What is being measured

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

  1. MTD defined as the highest IMC-A12 dose tested in which none or only one patient had a dose-limiting toxicity (DLT) attributed to IMC-A12 as assessed by NCI CTCAE version 4.0

    The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTCAE and nadir or maximum values for the laboratory measures), time of onset (i.e. course number), duration, and reversibility or outcome. Tables will be created to summarize these toxicities and side effects by dose and by course.

    Measured: First 1 month of therapy

  2. Toxicities and tolerability of this regimen as assessed by NCI CTCAE version 4.0

    Measured: 30 days

Secondary outcomes (3)

  1. Impact of cixutumumab on biomarkers related to the IGF-1R/IGF pathway

    Measured: From baseline to up to 5 years

  2. Objective response rate according to RECIST

    Measured: Up to 5 years

  3. Progression-free rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)

    Measured: Up to 5 years

Timeline

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

  1. First posted6 Nov 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01008566
Sponsor's protocol ID
NCI-2012-03186
Other IDs
NCI-2012-03186, PHI-64, CCC-PHI-64, 8155, PHI-64, 8155, N01CM00038, N01CM00071
Status last verified
May 2016
First submitted
5 Nov 2009
Last updated
12 May 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cixutumumab, Laboratory Biomarker Analysis and Sorafenib Tosylate in people with Adult Hepatocellular Carcinoma and Advanced Adult Hepatocellular Carcinoma, run by National Cancer Institute (NCI) at 6 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 17 inclusion and 15 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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?

MTD defined as the highest IMC-A12 dose tested in which none or only one patient had a dose-limiting toxicity (DLT) attributed to IMC-A12 as assessed by NCI CTCAE version 4.0 (time frame: First 1 month of therapy). The study lists 2 primary outcomes in all. 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 NCT01008566.

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 12 May 2016; AzTrials last refreshed its copy on 8 Nov 2026.

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