A Phase I Trial of ABI-007 Administered Weekly for Three Doses Every 4 Weeks in Patients With Advanced Non-Hematologic Malignancies
This will be a dose-escalating study. ABI-007 will be administered as an outpatient
infusion for three weeks followed by a week of rest. The treatment course will repeat every
28 days. No pretreatment will normally be considered necessary. Patients will have white
blood cell and platelet counts monitored as will indications of performance (Karnofsky
Performance Status), and will be asked to describe adverse events, if present. Patients
will be treated for a minimum of two cycles to be evaluable for the study, and may continue
in the study for four cycles within the study, if tumor response and safety parameters
warrant continuing. Patients may continue on study medication beyond this at the
investigator's discretion.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Michael J Hawkins, M.D.
Study Director
Celgene Corporation
United States: Food and Drug Administration
CA-005-0
NCT00046423
April 2000
Name | Location |
---|---|
Abraxis Bioscience, Inc. | Durham, North Carolina 27703 |