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

Solid Tumours Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743067
• Other study ID #: MET111648
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2008
• Last updated: July 24, 2017
• Start date: August 9, 2006
• Est. completion date: November 9, 2009

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00349609

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 9, 2009
• Est. primary completion date: May 2, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumours

Intervention

Drug:
• GSK1363089 (formerly XL880)
GSK1363089 will be available as solid capsules with dose unit of 20, 100 and 200 mg. Subjects will administer GSK1363089 capsules orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study MET111648 can be found on the GSK Clinical Study Register.