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A Phase II Trial of Dasatinib (BMS-354825) in Advanced Hepatocellular Carcinoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Adult Primary Hepatocellular Carcinoma, Advanced Adult Primary Liver Cancer, Recurrent Adult Primary Liver Cancer

Thank you

Trial Information

A Phase II Trial of Dasatinib (BMS-354825) in Advanced Hepatocellular Carcinoma


PRIMARY OBJECTIVES:

I. Determine the progression-free survival (PFS) rate and response rate (complete and
partial response) at 4 months in patients with unresectable advanced hepatocellular
carcinoma treated with dasatinib.

SECONDARY OBJECTIVES:

I. Determine the median PFS and overall survival of patients treated with this drug.

II. Assess the toxicity and tolerability of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at 4 weeks and then every 3-6
months thereafter.

Inclusion Criteria


Criteria:

- WBC >= 3,000/mm^3

- LVEF normal

- Histologically or cytologically confirmed hepatocellular carcinoma; Advanced disease,
unresectable disease, no Childs C criteria

- Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by
conventional techniques or >= 10 mm by spiral CT scan

- Not a candidate for percutaneous ethanol injection or radiofrequency ablation (RFA)

- Prior transarterial chemoembolization, ethanol, and RFA allowed if new lesions are
present in the liver and there are no other sites of disease

- No pleural effusion or ascites requiring paracentesis within the past 4 weeks

- No known brain metastases

- ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

- Life expectancy > 3 months

- Absolute neutrophil count >= 1,500/mm^3

- Platelet count >= 75,000/mm^3

- Bilirubin =< 2 times upper limit of normal (ULN)

- AST and ALT =<2.5 times ULN (5 times ULN if liver involvement by tumor)

- Creatinine =< 2 times ULN

- PT =< 1.5 times ULN (no anticoagulation)

- Albumin >= 2.5 mg/dL

- No history of allergic reactions attributed to compounds of similar chemical or
biological composition to dasatinib

- No evidence of encephalopathy

- No condition that would preclude ability to swallow and retain dasatinib tablets,
including any of the following:

- Gastrointestinal tract disease resulting in an inability to take oral
medication;

- Requirement for IV alimentation;

- Prior surgical procedures affecting absorption:

- Active peptic ulcer disease

- No clinically significant ECG abnormalities

- No clinically significant cardiovascular disease, including any of the following:

- Myocardial infarction or ventricular tachyarrhythmia within the past 6 months;

- Prolonged QTc >= 480 msec (Fridericia correction);

- Major conduction abnormality (unless cardiac pacemaker is present)

- No other uncontrolled illness, including, but not limited to, any of the following:

- Ongoing or active infection;

- History of significant bleeding disorder, including congenital (von Willebrand's
disease) or acquired disorders (antifactor VIII antibodies);

- Psychiatric illness or social situation that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- Recovered from all prior therapy

- One prior systemic chemotherapy regimen allowed

- Prior cryosurgery allowed

- More than 4 weeks since prior transarterial chemoembolization

- More than 4 weeks since prior radiotherapy

- Prior or concurrent localized palliative radiotherapy (i.e., bony metastasis) allowed
provided it was administered for =< 3 days

- At least 7 days since prior and no concurrent antithrombotic and/or antiplatelet
agents (e.g., warfarin, heparin, low molecular weight heparin, acetylsalicylic acid,
and/or ibuprofen)

- At least 7 days since prior and no concurrent agents with proarrhythmic potential

- At least 7 days since prior and no concurrent medications or substances that are
potent inhibitors or inducers of CYP3A4

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent embolization or chemoembolization

- No concurrent systemic antacids (H2 receptor antagonists or proton pump inhibitors)

- Locally active antacids allowed provided they are held for 2 hours before and 2 hours
after dasatinib dose

- No other concurrent investigational agents

- No other concurrent anticancer agents or therapies

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS)

Outcome Time Frame:

4 months

Safety Issue:

No

Principal Investigator

Heinz-Josef Lenz

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00224

NCT ID:

NCT00459108

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Adult Primary Hepatocellular Carcinoma
  • Advanced Adult Primary Liver Cancer
  • Recurrent Adult Primary Liver Cancer
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular

Name

Location

City of Hope Medical CenterDuarte, California  91010