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

A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally Daily to Subjects With Solid Tumors

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00743067

Enrollment

Registered

2008-08-28

Start date

2006-08-09

Completion date

2009-11-09

Last updated

2017-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumours

Keywords

XL880, MET inhibitor, GSK1363089, Solid Tumors, c-Met

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.

Interventions

DRUGGSK1363089 (formerly XL880)

GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026