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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00743067
First received: August 26, 2008
Last updated: August 20, 2009
Last verified: August 2009

August 26, 2008
August 20, 2009
August 2006
May 2009   (final data collection date for primary outcome measure)
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 ]
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
Complete list of historical versions of study NCT00743067 on ClinicalTrials.gov Archive Site
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 ]
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
Not Provided
Not Provided
 
A Dose Escalation Study of the Safety and Pharmacokinetics of GSK1363089 (Formerly XL880) Administered Orally Daily to Subjects With Solid Tumors
A Phase 1 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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumor Cancer
Drug: GSK1363089 (formerly XL880)
Experimental Drug
Other Name: GSK1363089 (formerly XL880)
Experimental: Arm 1
Intervention: Drug: GSK1363089 (formerly XL880)
Shapiro GI, McCallum S, Adams LM, Sherman L, Weller S, Swann S, Keer H, Miles D, Müller T, Lorusso P. A Phase 1 dose-escalation study of the safety and pharmacokinetics of once-daily oral foretinib, a multi-kinase inhibitor, in patients with solid tumors. Invest New Drugs. 2013 Jun;31(3):742-50. doi: 10.1007/s10637-012-9881-z. Epub 2012 Oct 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
May 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00743067
MET111648, XL880-002
Not Provided
Study Director, GSK
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP