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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00742131

Enrollment

Registered

2008-08-27

Start date

2005-03-17

Completion date

2011-08-29

Last updated

2017-07-31

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

Conditions

Solid Tumours

Keywords

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

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.

Interventions

DRUGGSK1363089

GSK1363089 will be administered orally as a cinnamon-flavored liquid (250 milligrams of GSK1363089 in 50 milliliters liquid \[5 milligrams/milliliter\] or 1000 milligrams of GSK1363089 in 50 milliliters liquid \[20 milligrams/milliliter\]) or as solid capsules of 20, 100, and/or 200 milligrams.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

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

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

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