NCT00085878

Brief Summary

This is a phase I, open-label, dose-escalation study of SB-485232. Subjects will receive SB-485232 administered as subcutaneous injections daily for 14 days. Dose escalation (enrollment into the next cohort) cannot occur until all three subjects have completed the previous cohort; 5 doses will be tested. An additional dosing regimen has been added to evaluate higher doses given twice weekly for 7 weeks. Therefore, the full evaluation period for each patient will extend out to approximately eleven weeks after the first day of SB-485232 dosing.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
1.5 years 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 16, 2008

Status Verified

October 1, 2008

First QC Date

June 16, 2004

Last Update Submit

October 15, 2008

Conditions

Solid Tumor Cancer

Keywords

IL-18subcutaneouspharmacokineticsPhase 1

Outcome Measures

Primary Outcomes (1)

  • - Safety and tolerability endpoints will include evaluation of adverse events and changes in laboratory values and clinical variables from pre-dose values.

    11 Weeks

Secondary Outcomes (1)

  • - Biologically effective dose based. - Pharmacokinetic endpoints: AUC, Adverse Events, cmax, tmax, and t1/2. - Presence or absence of anti-SB-485232 antibodies. - Pharmacodynamic endpoints. - Radiographic tumor assessments.

    11 Weeks

Interventions

SB-485232DRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of malignancy.
  • Subjects with solid tumors must have locally advanced or metastatic disease at the time of enrollment.
  • Measurable or evaluable disease that is refractory or resistant to standard therapy or for which there is no effective standard therapy.
  • Predicted life expectancy of at least 12 weeks.
  • Kinesin spindle protein (KPS) of greater than 70%.
  • No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within 4 weeks before beginning treatment with SB-485232 (6 weeks for nitrosoureas and mitomycin C).
  • Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study.
  • Provide written informed consent.
  • Absence of anti-SB-485232 antibodies.
  • Hemoglobin greater than or equal to 9 g/dL.
  • Absolute neutrophil count greater than or equal to 1.5 X 109 /L.
  • Platelet count greater than or equal to 100 X 109 /L.
  • Partial thromboplastin time (PTT) and prothrombin time/international normalized ratio (PT/INR) within normal limits.
  • Serum creatinine less than or equal to 1.5 mg/dL (135 µmol/L) or estimated creatinine clearance greater than 50 mL/min (calculated by the Cockcroft-Gault Formula).
  • Total serum bilirubin less than or equal to 1.5 mg/dL.
  • +4 more criteria

You may not qualify if:

  • Women who are pregnant or are breast-feeding.
  • Severe or uncontrolled infections requiring systemic antibiotic therapy.
  • Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent.
  • Known leptomeningeal disease or evidence of prior or current metastatic brain disease.
  • Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy.
  • Receiving concurrent systemic steroids.
  • History of ventricular arrhythmias requiring drug or device therapy.
  • Any severe concurrent disease or condition, including significant autoimmune diseases, which in the judgment of the principal investigator, would make the subject inappropriate for study participation.
  • Any unresolved or unstable serious toxicity from prior administration of another investigational drug.
  • Any investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of SB-485232.
  • Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study.
  • Received prior treatment with SB-485232.
  • Poor venous access.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

GSK Investigational Site

Santa Monica, California, 90404-2104, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46202, United States

Location

GSK Investigational Site

Durham, North Carolina, 27705, United States

Location

GSK Investigational Site

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Interventions

Interleukin-18

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

January 1, 2003

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

US(4)