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A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent Or Metastatic Hepatocellular Carcinoma

Phase 2
18 Years
Not Enrolling
Liver Cancer

Thank you

Trial Information

A Phase II Study Of SB-715992 (NSC 727990) In Patients With Locally Advanced, Recurrent Or Metastatic Hepatocellular Carcinoma


- Determine the efficacy of SB-715992, in terms of response rate and stable disease rate,
in patients with locally advanced, recurrent, or metastatic hepatocellular carcinoma.

- Determine the toxicity of this drug in these patients.

- Determine the early progression rate and response duration in patients treated with
this drug.

- Determine the pharmacokinetics of this drug in these patients.

- Correlate pharmacokinetics with safety and efficacy of this drug in these patients.

- Correlate tumor expression of β-tubulin and kinesin spindle protein with clinical
outcomes in patients treated with this drug.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive SB-715992 IV over 1 hour on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity.

All patients are followed at 4 weeks. Patients with ongoing stable or responding disease are
followed every 3 months until relapse.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-14

Inclusion Criteria


- Histologically or cytologically confirmed hepatocellular carcinoma

- Locally advanced, recurrent, or metastatic disease

- Histologically confirmed disease must have archival paraffin-fixed tumor
specimen available

- Measurable disease

- At least 1 unidimensionally measurable site of disease ≥ 20 mm by x-ray,
physical exam, or non-spiral CT scan OR ≥ 10 mm by spiral CT scan

- Outside of previously irradiated area

- Patients whose sole site of disease is in a previously irradiated field are
eligible provided there is evidence of disease progression OR new lesions
documented in the irradiated field

- Bone metastases are not considered measurable disease

- Not curable by standard therapies

- No cholangiocarcinoma



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- At least 12 weeks


- Absolute granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 80,000/mm^3


- Bilirubin ≤ 2 times upper limit of normal (ULN)

- AST ≤ 5 times ULN

- Must have hepatic reserve of Child-Turcotte-Pugh class A or better


- Creatinine clearance ≥ 60 mL/min


- No myocardial infarction within the past 6 months

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No active cardiomyopathy

- No uncontrolled hypertension


- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No clinical evidence of encephalopathy

- No ongoing or active infection

- No history of allergic reaction attributed to compounds of similar chemical or
biological composition to SB-715992

- No psychiatric illness or social situation that would preclude study compliance

- No other uncontrolled illness

- No other malignancies within the past 5 years except adequately treated nonmelanoma
skin cancer, curatively treated carcinoma in situ of the cervix, or other curatively
treated solid tumors with no evidence of disease for at least 5 years


Biologic therapy

- Not specified


- At least 4 weeks since prior intra-hepatic chemotherapy as a component of
trans-arterial chemoembolization and recovered

- Documented disease progression

- No prior systemic chemotherapy

Endocrine therapy

- Not specified


- See Disease Characteristics

- At least 4 weeks since prior radiotherapy

- Exceptions may be made for low-dose, nonmyelosuppressive radiotherapy


- At least 4 weeks since prior major surgery

- Prior liver transplantation allowed


- No other prior systemic therapy

- At least 4 weeks since prior local ablative therapy (e.g., radiofrequency ablation or
ethanol injection) and recovered

- Documented disease progression

- More than 28 days since prior investigational agents

- More than 14 days since prior and no concurrent use of any of the following CYP3A4
inhibitors or inducers:

- Clarithromycin

- Erythromycin

- Troleandomycin

- Itraconazole

- Ketoconazole

- Fluconazole (dose > 200 mg/day)

- Voriconazole

- Nefazodone

- Fluvoxamine

- Verapamil

- Diltiazem

- Grapefruit juice

- Bitter orange

- Phenytoin

- Carbamazepine

- Phenobarbital

- Oxcarbazepine

- Rifampin

- Rifabutin

- Rifapentine

- Hypericum perforatum (St. John's wort)

- Modafinil

- At least 6 months since prior and no concurrent amiodarone

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No other concurrent anticancer therapy

- No other concurrent investigational agents

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Jennifer Knox, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:




Start Date:

November 2004

Completion Date:

September 2008

Related Keywords:

  • Liver Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • recurrent adult primary liver cancer
  • Liver Neoplasms
  • Carcinoma, Hepatocellular