Spots Global Cancer Trial Database for A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies
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Trial Identification
Brief Title: A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies
Official Title: A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies
Study ID: NCT00405743
Study Description
Brief Summary: Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing
Detailed Description: This is a multicentre clinical study conducted in the USA and in Europe. It is an open label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK), and efficacy of CP-4055 as a single agent when administered as a 2 hours intravenous (IV) or a continuous IV (CIV) infusion administered daily for 5 days in a 21-day cycle, either alone or with idarubicin IV, in patients with refractory/relapsed hematologic malignancies who have either failed potentially curative therapy or are considered unsuitable for standard therapy. In a second phase of the study the efficacy of single agent CP-4055 in patients with AML may be assessed. It is intended that patients receive a minimum of two cycles of therapy in the absence of unacceptable toxicity or significant disease progression.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mew York Medical College, Division of Oncology, Valhalla, New York, United States
Duke University Medical Center (DUMC), Durham, North Carolina, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd., San Antonio, Texas, United States
Hematology Service, Hôpital Beaujon and Hôpital Avicenne, Bobigny, Paris, France
Centre Hospitalier Universitaire, CHU de Lyon, Service d'Hematologie Clinique, Lyon, , France
Institut Paoli-Calmettes, Marseille, , France
Centre Hospitalier Universitaire CHU de Toulouse, Hopital Purpan, Toulouse, , France
University Hospital Benjamin Franklin Med.Clinic III, Berlin, , Germany
Department of Internal Medicine Klinikum der Johann Wolfgang Goethe-Universität Medizinische Klinik II, Frankfurt am Main, , Germany
Westfälische Wilhelms-Universität Münster Medizinische Klinik und Polikinik Innere Medizin A, Münster, , Germany
Institute of Hematology & Medical Oncology L and A Serágnoli University of Bologna, Bologna, , Italy
Universitá degli Studi di Roma Ematologia- Policlinico Tor Vergata, Rome, , Italy
Department of Hematology, Ullevål University Hospital, University of Oslo, Oslo, , Norway
Christie Hospital, Manchester, , United Kingdom
Contact Details
Name: Francis J Giles, MD
Affiliation: Institute for Drug Development (IDD), Cancer Therapy and Research Center, San Antonio, Texas, USA
Role: PRINCIPAL_INVESTIGATOR
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