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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumor Cancer

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Trial Information

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


Inclusion Criteria:



- Histologically confirmed solid tumor which is metastatic or unresectable with no
known effective treatment measures,

- ECOG performance status of
- 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.

Type of Study:

Interventional

Study Design:

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

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

Outcome Time Frame:

2 years

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

MET111648

NCT ID:

NCT00743067

Start Date:

August 2006

Completion Date:

May 2009

Related Keywords:

  • Solid Tumor Cancer
  • Solid Tumors
  • GSK1363089
  • XL880
  • MET inhibitor
  • c-Met
  • Neoplasms

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