A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumours
• Interventions: Drug: GSK1363089

• Registration Number: NCT00742131
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This clinical study is being conducted at two sites to determine the optimum dose, safety, and tolerability of GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-17
• Primary Completion: 2008-05-13
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Study Completion: 2011-08-29
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-27
• Last Update Posted: 2017-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Histologically confirmed solid tumor which is metastatic or unresectable with no known effective treatment measures,
• ECOG performance status of </= 2.
• Adequate bone marrow reserve, hepatic, renal, and cardiovascular function,
• Negative pregnancy test.

Exclusion Criteria

• Chemotherapy within 4-6 weeks of the start of treatment,
• Radiotherapy within 4 weeks of the start of treatment,
• Known brain metastasis,
• Uncontrolled medical disorder such as infection or cardiovascular disease,
• HIV positive,
• Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects receiving GSK1363089	GSK1363089	Eligible subjects will receive GSK1363089 administered orally as a cinnamon-flavored liquid or as solid capsules with the starting dose for cohort 1 as 0.1 milligram/kilogram. Subjects in cohorts 1, 2, and 3A will receive GSK1363089 in the liquid formulation, while Cohorts 3B, 4, 5, 6, 7, and 8 will receive GSK1363089 in the solid capsule formulation.

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) and to assess the safety and tolerability of GSK1363089 administered orally (up to twelve different doses) to subjects with solid tumors	3 years

Secondary Outcome Measures

Name	Time	Method
To evaluate pharmacokinetic (PK) and pharmacodynamic parameters of GSK1363089, radiographically evaluate the effects of GSK1363089 on tumors, evaluate tumor response after repeat administration of GSK1363089	1 year