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

Phase 1

Completed

• Conditions: Solid Tumor Cancer; Lymphoma

• Registration Number: NCT00085904
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2004-06-16
• Study First Submitted QC: 2004-06-17
• Study First Posted: 2004-06-18
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-09
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇺🇸 Pittsburgh, Pennsylvania, United States