A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Phase I
- Three eligible patients will be enrolled at each dose level (DL), according to standard
dose escalation decision rules
- Patients will receive CP-4055 at increasing DLs until the maximum tolerated dose and
the recommended dose (RD) have been established
Phase II
- Step 1 (The patient inclusion may stop after this step):
- Patients will be enrolled at the RD until there are maximum 16 evaluable patients
at this DL
- Step 2:
- Depending on the response rate at step 1, up to 26 patients will be included and
treated at step 2
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Determine recommended dose for phase II studies of CP-4055 when given five consecutive days twice in a 4 week schedule, D1-5 and D8(+2)-12(+2) q4w
August 2009/June 2010
No
Sandro Pignata, MD
Principal Investigator
Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
United States: Food and Drug Administration
CP4055-204
NCT00831636
April 2008
April 2010
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