Completed

A Phase I, Dose Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Daily Subcutaneous Injections in Adult Patients With Solid Tumors

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What is being tested

Data Collection

Who is being recruted

Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2003
See protocol details

Summary

Principal SponsorGlaxoSmithKline
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitleA Phase I, Dose Escalation Study to Assess the Safety and Pharmacokinetics of SB- 485232 Administered as Daily Subcutaneous Injections in Adult Patients With Solid Tumors 
NCT00085878
Principal SponsorGlaxoSmithKline
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
25 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.

Other Ways to Assign Participants
Randomized allocation
: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment
: Participants are split into separate groups, each receiving a different treatment.

Cross-over assignment
: Participants switch between treatments during the study.

Factorial assignment
: Participants receive different combinations of treatments.

Sequential assignment
: Participants receive treatments one after another in a specific order, possibly based on individual responses.

Other assignment
: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Double-blind
: Neither participants nor researchers know which treatment is given.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Neoplasms
Criteria

Inclusion Criteria: * 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. * Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3 X ULN. * Sexually active males or females of reproductive capacity must use adequate contraception. * For subjects with a history of coronary artery disease, stress test must be within normal limits. * Subjects with a history of congestive heart failure, myocardial infarction or prior anthracycline chemotherapy must have a Multiple Gated Acquisition (MUGA) scan with a left ventricular ejection fraction of greater than 40%. Exclusion Criteria: * 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 4 locations
Suspended
GSK Investigational SiteSanta Monica, United StatesSee the location
Suspended
GSK Investigational SiteIndianapolis, United States
Suspended
GSK Investigational SiteDurham, United States
Suspended
GSK Investigational SitePhiladelphia, United States
Completed4 Study Centers