Ispinesib In Combination With Capecitabine In Patients With Solid Tumors
Completed · Phase 1
Conditions studied: Solid Tumor Cancer
In brief
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 and capecitabine is dosed orally, twice a day for 14 days with a 1 week rest period. A patient may continue to receive treatment as long as they are benefiting from the treatment. Blood samples will be taken at specific times to measure the amount of both drugs in your body at specific times after the drug is given. Blood samples will also be taken for lab tests such as complete blood counts and clinical chemistries. Physical exams will be performed before each treatment with Ispinesib. During the treatment phase, the patients will undergo regular assessments for safety and clinical response.
Key facts
- Study ID
- NCT00119171
- Run by
- GlaxoSmithKline
- People needed
- 30
- Starts
- 2004-11-01
- Last updated by the study team
- 2008-10-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- GSK Investigational Site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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