A Phase I Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB743921 on a Once Every 3 Week Schedule in Patients With 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 Study to Determine the Safety and Pharmacokinetics of Intravenous Administration of SB743921 on a Once Every 3 Week Schedule in Patients With Solid Tumors
Inclusion Criteria
Inclusion criteria:
- Histologically or cytologically confirmed diagnosis of: a) Advanced solid tumor
malignancy that is not responsive to standard therapies or for which there is no
standard therapy; OR b) B-cell or T-cell lymphoma (excluding HIV-associated lymphoma)
that has relapsed or is refractory after prior chemotherapy or radiotherapy and
autologous or allogeneic bone marrow transplantation (if appropriate) AND/OR for
which salvage chemotherapy, radiotherapy, or bone marrow transplantation is not
indicated or has been refused by the patient.
- ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-2.
Exclusion criteria:
- Pre-existing hemolytic anemia.
- Pre-existing peripheral neuropathy greater than or equal grade 2.
- 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.
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 will include evaluation of adverse events (AE) and changes from baseline in vital signs and clinical laboratory parameters. PK endpoints will include Cl, Vd, AUC, Cmax, and t½.
Principal Investigator
GSK Clinical Trials, MD
Investigator Role:
Study Director
Investigator Affiliation:
GlaxoSmithKline
Authority:
United States: Food and Drug Administration
Study ID:
743921/001
NCT ID:
NCT00136513
Start Date:
April 2004
Completion Date:
Related Keywords:
- Solid Tumor Cancer
- Safety
- tolerability
- dose limiting toxicity
- solid tumors
- Neoplasms
Name | Location |
|---|---|
| GSK Investigational Site | Green Bay, Wisconsin 54301 |
| GSK Investigational Site | Pittsburgh, Pennsylvania 15213 |
