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

Primary Purpose

Solid Tumor Cancer, Lymphoma

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SB-485232
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Solid Tumor Cancer focused on measuring Advanced cancer, IL-18, repeat dosing, Phase 1, pharmacokinetics, oncology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

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.

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.

Full Information

First Posted
June 16, 2004
Last Updated
October 9, 2008
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00085904
Brief Title
Dose-Escalating Study Of SB-485232 Administered Intravenously Every 28 Days To Adults With Solid Tumors Or Lymphomas
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumor Cancer, Lymphoma
Keywords
Advanced cancer, IL-18, repeat dosing, Phase 1, pharmacokinetics, oncology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SB-485232
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
GSK Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213-2584
Country
United States

12. IPD Sharing Statement

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

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