Phase 1 Study of Ixabepilone in Combination With Cisplatin in Subjects With Advanced Solid Tumors
Escalation Phase Subjects: Primary solid tumor not curable by local measures such as
surgery, radiation
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participants Experiencing Dose Limiting Toxicity (DLT)
DLT=any of the following treatment-related events:Grade(Gr)3/4 diarrhea despite the use of adequate/maximal medical intervention and/or prophylaxis;other Gr3 or greater nonhematological toxicity requiring removal from further study therapy;delayed recovery from treatment-related toxicity delaying scheduled retreatment for >3 weeks;Gr4 neutropenia (absolute neutrophil count <500 cells/mm^3) for >=5 consecutive days or Gr3/4 neutropenia of any duration with sepsis or fever >38.5°C;thrombocytopenia <25,000 cells/mm^3 or bleeding requiring platelet transfusion. Grades defined in Outcome Measure 7.
Within the first 21 days of first cycle
Yes
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA163-177
NCT00832117
May 2009
January 2011
Name | Location |
---|---|
Georgetown University Medical Center | Washington, District of Columbia 20007 |
The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Penn State Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |