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

This study is ongoing, but not recruiting participants.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00742131

Purpose

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.

Condition	Intervention	Phase
Solid Tumor Cancer	Drug: GSK1363089 (formerly XL880)	Phase I

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally to Subjects With Solid Tumors

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	40
Study Start Date:	April 2005

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742131

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	MET111647, XL880-001
Study First Received:	August 26, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00742131
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

Solid Tumors
GSK1363089
XL880
MET inhibitor
c-Met

ClinicalTrials.gov processed this record on January 16, 2009