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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742131
• Other study ID #: MET111647
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2008
• Last updated: July 27, 2017
• Start date: March 17, 2005
• Est. completion date: August 29, 2011

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 GSK1363089 treatment in adults with solid tumors. This study is no longer recruiting subjects.

Other known NCT identifiers

• NCT00105924

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 29, 2011
• Est. primary completion date: May 13, 2008
• 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:

• 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

Related Conditions & MeSH terms

• Solid Tumours

Intervention

Drug:
• GSK1363089
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

References & Publications (1)

Eder JP, Shapiro GI, Appleman LJ, Zhu AX, Miles D, Keer H, Cancilla B, Chu F, Hitchcock-Bryan S, Sherman L, McCallum S, Heath EI, Boerner SA, LoRusso PM. A phase I study of foretinib, a multi-targeted inhibitor of c-Met and vascular endothelial growth factor receptor 2. Clin Cancer Res. 2010 Jul 1;16(13):3507-16. doi: 10.1158/1078-0432.CCR-10-0574. Epub 2010 May 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

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 MET111647 can be found on the GSK Clinical Study Register.