SB-715992 in Treating Patients With Locally Advanced, Recurrent, or Metastatic Liver Cancer

August 3, 2023 updated by: NCIC Clinical Trials Group

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

RATIONALE: Drugs used in chemotherapy, such as SB-715992, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well SB-715992 works in treating patients with locally advanced, recurrent, or metastatic liver cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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 months.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BCCA - Vancouver Cancer Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre at Hamilton Health Sciences
      • Kingston, Ontario, Canada, K7L 5P9
        • Cancer Centre of Southeastern Ontario at Kingston
      • Toronto, Ontario, Canada, M5G 2M9
        • Univ. Health Network-Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 80,000/mm^3

Hepatic

  • Bilirubin ≤ 2 times upper limit of normal (ULN)
  • AST ≤ 5 times ULN
  • Must have hepatic reserve of Child-Turcotte-Pugh class A or better

Renal

  • Creatinine clearance ≥ 60 mL/min

Cardiovascular

  • 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

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • 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

Radiotherapy

  • See Disease Characteristics

  • At least 4 weeks since prior radiotherapy

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

Surgery

  • At least 4 weeks since prior major surgery
  • Prior liver transplantation allowed

Other

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity
Time Frame: 4 years
4 years
Pharmacokinetics at day 1 of course 1 (day 1 of course 2 if dose is adjusted)
Time Frame: 4 years
4 years
Molecular correlates on archival tumor specimens and peripheral blood mononuclear cells (PBMCs)
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NCIC Clinical Trials Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Jennifer Knox, MD, Princess Margaret Hospital, Canada
  • Study Chair: Sharlene Gill, MD, British Columbia Cancer Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 8, 2005

Primary Completion (Actual)

September 26, 2006

Study Completion (Actual)

September 22, 2008

Study Registration Dates

First Submitted

November 9, 2004

First Submitted That Met QC Criteria

November 8, 2004

First Posted (Estimated)

November 9, 2004

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 3, 2023

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I168
  • CAN-NCIC-IND168 (Other Identifier: PDQ)
  • CDR0000391839 (Other Identifier: PDQ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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