Ovarian Cancer Clinical Trial
Official title:
A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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