A Phase I, Open-Label, Dose-Escalation Study of the Safety and Tolerability of Ispinesib in Combination With Carboplatin 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 Carboplatin 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.
Exclusion criteria:
- Females who are pregnant or nursing.
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2. Greater than or
equal to 4 prior chemotherapy regimens including neoadjuvant/adjuvant chemotherapy,
except breast cancer subjects who may have received more than 4 prior chemotherapy
regimens.
- Absolute neutrophil count less than 1,500/mm3.
- Platelets less than 100,000/mm3.
- Hemoglobin less than 9 g/dL.
- Total bilirubin greater than1.5 mg/dL.
- AST/ALT greater than 2.5 X upper limit of normal.
- Creatinine clearance less than or equal to 50 mL/min (calculated by the Cockcroft
Gault Formula).
- Known contra-indications to the use of carboplatin, cisplatin, or other
platinum-containing compounds.
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:
Safety and tolerability endpoints will consist of the valuation of adverse events (AEs),vital signs and laboratory values. A dose regimen where = 1 of 6 (or =17%) subjects experience a dose-limiting toxicity.
Principal Investigator
GSK Clinical Trials, MD
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
KSP10014
NCT ID:
NCT00136578
Start Date:
October 2004
Completion Date:
Related Keywords:
- Solid Tumor Cancer
- Safety
- tolerability
- dose limiting toxicity
- solid tumors
- carboplatin
- Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Germantown, Tennessee 38138 |
