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

Over 18 Years
+32 Eligibility Criteria
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 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2003

Actual 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 27, 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 enrolled

Total 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.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

19 inclusion criteria required to participate
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.
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13 exclusion criteria prevent from participating
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.
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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 Site

Santa Monica, United StatesOpen GSK Investigational Site in Google Maps
Suspended

GSK Investigational Site

Indianapolis, United States
Suspended

GSK Investigational Site

Durham, United States
Suspended

GSK Investigational Site

Philadelphia, United States
Completed4 Study Centers