Dose-Escalating Study Of SB-485232 Administered Intravenously Every 28 Days To Adults With Solid Tumors Or Lymphomas

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00085904
First received: June 16, 2004
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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.


Condition Intervention Phase
Solid Tumor Cancer
Lymphoma
Drug: SB-485232
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 Months ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 6 Months ]

Enrollment: 12
Study Start Date: April 2004
Intervention Details:
    Drug: SB-485232
    Other Name: SB-485232
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00085904

Locations
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
GSK Investigational Site
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213-2584
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00085904     History of Changes
Other Study ID Numbers: 485232/003, 003
Study First Received: June 16, 2004
Last Updated: October 9, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Advanced cancer
IL-18
repeat dosing
Phase 1
pharmacokinetics
oncology

Additional relevant MeSH terms:
Neoplasms
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014