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

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

Sponsors

Lead Sponsor: GlaxoSmithKline

Source GlaxoSmithKline
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.

Overall Status Completed
Start Date April 2004
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
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
Enrollment 12
Condition
Intervention

Intervention Type: Drug

Intervention Name: SB-485232

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
GSK Clinical Trials, MD Study Director GlaxoSmithKline
Location
Facility:
GSK Investigational Site | Indianapolis, Indiana, 46202, United States
GSK Investigational Site | Boston, Massachusetts, 02215, United States
GSK Investigational Site | Pittsburgh, Pennsylvania, 15213-2584, United States
Location Countries

United States

Verification Date

October 2008

Responsible Party

Name Title: Study Director

Organization: GSK

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov