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

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.

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Key information

Conditions

Solid Tumours

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GSK1363089 (formerly XL880)

Drug

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

Primary outcomes

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

Time frame: 2 years

Secondary outcomes

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

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2009
Study completion: 2009
First posted: Aug 28, 2008
Registry last updated: Jul 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed