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

Phase 1

Completed

• Conditions: Solid Tumours
• Interventions: Drug: GSK1363089 (formerly XL880)

• Registration Number: NCT00743067
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-09
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2009-05-02
• Study Completion: 2009-11-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-24
• Last Update Posted: 2017-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

• Anticancer therapy within 30 days of the start of treatment,
• Received radiation to =25% of bone marrow within 30 days of treatment.
• Known brain metastasis,
• Uncontrolled intercurrent illness,
• HIV positive,
• Pregnant or breastfeeding women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	GSK1363089 (formerly XL880)	Cohort 1 will include 60 milligram (mg) of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Cohort 3	GSK1363089 (formerly XL880)	Cohort 3 will include 240 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Cohort 4	GSK1363089 (formerly XL880)	Cohort 4 will include 480 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Cohort 2	GSK1363089 (formerly XL880)	Cohort 2 will include 120 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.
Cohort 5	GSK1363089 (formerly XL880)	Cohort 5 will include 960 mg of GSK1363089. Dose escalation will be 100% if there is no drug-related AEs of Grade 2 or higher in previous cohort. Dose escalation will be 50% in case there is Grade 2 drug-related AEs in any previous cohort.

Primary Outcome Measures

Name	Time	Method
To determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of daily oral administration of GSK1363089 in subjects with solid tumors	2 years

Secondary Outcome Measures

Name	Time	Method
Plasma pharmacokinetics (PK) of daily GSK1363089 in subjects with solid tumors, pharmacodynamic effects of daily GSK1363089, Long-term safety and tolerability of daily GSK1363089, Tumor response after daily administration of GSK1363089	1 year