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

This study is ongoing, but not recruiting participants.

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00743067

Purpose

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.

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	37
Study Start Date:	June 2006

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:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743067

Locations

United States, Massachusetts
GSK Clinical Trial Call Center
Boston, Massachusetts, United States, 02115
United States, Michigan
GSK Clinical Trial Call Center
Detroit, Michigan, United States, 48201

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Study ID Numbers:	MET111648, XL880-002
Study First Received:	August 26, 2008
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00743067
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