Status:
COMPLETED
Ispinesib In Combination With Capecitabine In Patients With Solid Tumors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Solid Tumor Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the dose regimen of Ispinesib in combination with capecitabine in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion every 3 weeks ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of an advanced solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
- Bone marrow function: - ANC greater than 1500/mm3.
- Platelet count greater than or equal to 100,000/mm3.
- Hemoglobin greater than 9 g/dL.
- Renal function: - Calculated creatinine clearance greater than or equal to 50 mL.min.
- Total bilirubin greater than 1.5 mg/dL.
- AST/ALT less than 2.5 X upper limit of normal.
- Exclusion criteria:
- Females who are pregnant or nursing.
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2.
- Known deficiency in dihydropyrimidine dehydrogenase (DSD).
Exclusion
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00119171
Start Date
November 1 2004
Last Update
October 16 2008
Active Locations (1)
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1
GSK Investigational Site
San Antonio, Texas, United States, 78229