A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Solid Tumor Cancer
Both
Solid Tumor Cancer
Trial Information
A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Capecitabine on an Every 21-Day Schedule in Subjects With Advanced Solid Tumors
Inclusion Criteria
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).
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Plasma levels for SB-715992 and Capecitabine
Outcome Time Frame:
will be checked at Day 1 for Cycle 1.
Principal Investigator
GSK Clinical Trials, MD
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
KSP10004
NCT ID:
NCT00119171
Start Date:
November 2004
Completion Date:
Related Keywords:
- Solid Tumor Cancer
- Safety
- tolerability
- dose limiting toxicity
- solid tumors
- capecitabine
- Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Fort Worth, Texas 76104 |
