Status:
COMPLETED
SB-715992 In Combination With Docetaxel 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 SB-715992 in combination with docetaxel in patients with solid tumors. SB-715992 and docetaxel were dosed by 1-hour intravenous infusion e...
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 60 mL/min (calculated by the Cockcroft Gault Formula).
- Known contraindications to the use of docetaxel or to other drugs formulated with polysorbate 80.
Exclusion
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00169520
Start Date
June 1 2004
Last Update
October 16 2008
Active Locations (2)
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1
GSK Investigational Site
Oxford, Oxfordshire, United Kingdom, OX2 6PD
2
GSK Investigational Site
London, United Kingdom, SW3 6JJ