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
  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 Tumor Cancer
Drug: GSK1363089 (formerly XL880)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 [ Time Frame: 2 years ]

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 [ Time Frame: 1 year ]

Enrollment: 37
Study Start Date: August 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: GSK1363089 (formerly XL880)
Experimental Drug
Other Name: GSK1363089 (formerly XL880)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00743067     History of Changes
Obsolete Identifiers: NCT00349609
Other Study ID Numbers: MET111648, XL880-002
Study First Received: August 26, 2008
Last Updated: August 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Solid Tumors
GSK1363089
XL880
MET inhibitor
c-Met

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on August 27, 2014