Status:
COMPLETED
Ispinesib In Combination With Carboplatin In Patients With Solid Tumors
Lead Sponsor:
GlaxoSmithKline
Conditions:
Solid Tumours
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 carboplatin in patients with solid tumors. Ispinesib is dosed by 1-hour intravenous infusion and carboplatin...
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.
- 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.
Exclusion
Key Trial Info
Start Date :
October 20 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00136578
Start Date
October 20 2004
End Date
October 25 2006
Last Update
September 25 2017
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Nashville, Tennessee, United States, 37203
2
GSK Investigational Site
Newcastle upon Tyne, Northumberland, United Kingdom, NE4 6BE