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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
U.Z. Gasthuisberg, Gynecologic Oncology, Herestraat 49
Leuven, Belgium
Medical Oncology C, National Cancer Institute, Centro di Riferimento Oncologico
Aviano (PN), Italy
Medical Oncology B, National Cancer Institute, Via Mariano Semmola
Naples, Italy
Department of Oncology, Catholic University of the Sacred Heart
Rome, Italy
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
Time frame: August 2009/June 2010
Phase II: Determine the antitumour activity of CP-4055
Time frame: August 2009/June 2010
Determine pharmacokinetic (PK) parameters
Time frame: August 2009/June 2010
Explore the time to progression (TTP)
Time frame: August 2009/June 2010
Investigate the duration of tumour response
Time frame: August 2009/June 2010
Determine the nature and degree of toxicity of CP-4055 in this patient population
Time frame: August 2009/June 2010
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Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina
Rome, Italy