Spots Global Cancer Trial Database for A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
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Trial Identification
Brief Title: A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Official Title: A Phase I/II Study of CP-4055 in Patients With Platinum Resistant Ovarian Cancer
Study ID: NCT00831636
Conditions
Study Description
Brief Summary: 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
Detailed Description: 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
Medical Oncology, Fatebenefratelli Hospital, Isola Tiberina, Rome, , Italy
Contact Details
Name: Sandro Pignata, MD
Affiliation: Medical Oncology B, National Cancer Institute, Via Mariano Semmola, IT-80131 Naples, Italy
Role: PRINCIPAL_INVESTIGATOR
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