Know Cancer

or
forgot password

A Phase I, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Five Daily Intravenous Infusions Repeated Every 28 Days in Adult Patients With Solid Tumors and Lymphomas


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor Cancer, Lymphoma

Thank you

Trial Information

A Phase I, Dose-Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Five Daily Intravenous Infusions Repeated Every 28 Days in Adult Patients With Solid Tumors and Lymphomas

Inclusion Criteria


Inclusion criteria:

- Histopathological confirmation of cancer limited to a solid tumor malignancy or
follicular lymphoma.

- Advanced or metastatic disease.

- Measurable disease.

- Females of child-bearing potential must use adequate birth control.

- Karnofsky Performance Status of 70% or greater.

- Predicted life expectancy of at least 12 weeks in the estimation of the physician
conducting the study (Principal Investigator).

- Adequate laboratory results.

- Subjects with history of coronary artery disease must have a stress test without
clinically significant abnormalities.

- Subjects with a history of congestive heart failure, myocardial infarction or prior
anthracycline chemotherapy, must have a MUGA (Multiple Gated Acquisition) scan which
demonstrates a left ventricular ejection fraction equal to or greater than 40%.

- Signed informed consent form

Exclusion Criteria:

- Female subject is pregnant or nursing (lactating).

- Active, chronic or uncontrolled infections requiring systemic antibiotic therapy.

- Serious medical or psychiatric disorder that would interfere with the subject''s
safety or ability to sign the informed consent.

- Leptomeningeal disease or evidence of prior or current metastatic brain disease.

- Receiving concurrent chemotherapy, immunotherapy, radiotherapy, corticosteroid
therapy, or investigational therapy.

- Received chemotherapy, radiotherapy, immunotherapy, hormonal therapy or biological
therapy for cancer or underwent a surgical procedure (except for minor surgical
procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks in case
of nitrosureas or mitomycin C).

- Exposed to an investigational drug within 30 days or 5 half-lives (whichever is
longer) preceding the first dose of SB-485232.

- Severe concurrent disease or condition, including clinically significant autoimmune
disease, which in the judgement of the physician conducting the study (the principal
investigator) would render the patient inappropriate for study participation.

- History of ventricular arrhythmias requiring drug or device therapy.

- An unresolved or unstable, serious toxicity from prior administration of another
investigational product.

- Psychological, familial, sociological, or geographical limitations that do not permit
compliance with this protocol.

- Received prior SB-485232 therapy.

- Poor venous access.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluation of adverse events and changes in laboratory values. The potential dose is a dose regimen with no more than 2 out of 6 patients experiencing a dose-limiting toxicity.

Outcome Time Frame:

6 Months

Principal Investigator

GSK Clinical Trials, MD

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

485232/003

NCT ID:

NCT00085904

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Solid Tumor Cancer
  • Lymphoma
  • Advanced cancer
  • IL-18
  • repeat dosing
  • Phase 1
  • pharmacokinetics
  • oncology
  • Lymphoma
  • Neoplasms

Name

Location

GSK Investigational SiteIndianapolis, Indiana  46260
GSK Investigational SiteSpringfield, Massachusetts  01107
GSK Investigational SitePittsburgh, Pennsylvania  15213