NCT00085904

Brief Summary

SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas. Subjects may receive up to 6 cycles of treatment unless progressive disease or unacceptable toxicity is noted. Three dose levels of drug will be investigated. Safety evaluations, including blood sampling for various laboratory tests, will be conducted. Additional blood samples will also be taken to measure the amount of drug in the body at specific times.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2004

Completed
Last Updated

October 13, 2008

Status Verified

October 1, 2008

First QC Date

June 16, 2004

Last Update Submit

October 9, 2008

Conditions

Solid Tumor CancerLymphoma

Keywords

Advanced cancerIL-18repeat dosingPhase 1pharmacokineticsoncology

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 Months

Secondary Outcomes (1)

  • Evaluation for the presence of anti-SB-485232 antibodies, IL-18 neutralizing activity, and clinical sequelae. Pharmacokinetic endpoints are AUC, Cmax, Cmin, CL,Vss, and t1/2. Flow cytometry data. Assessments of disease.

    6 Months

Interventions

SB-485232DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Boston, Massachusetts, 02215, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213-2584, United States

Location

MeSH Terms

Conditions

LymphomaNeoplasms

Interventions

Interleukin-18

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • GSK Clinical Trials, MD

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 16, 2004

First Posted

June 18, 2004

Study Start

April 1, 2004

Last Updated

October 13, 2008

Record last verified: 2008-10

Locations

US(3)