A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

Completed · Phase 1/Phase 2

Conditions studied: Hematologic Malignancies, AML

In brief

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

Key facts

Study ID

NCT00405743

Run by

Clavis Pharma

People needed

153

Starts

2006-05-01

Expected to finish

2010-05-01

Last updated by the study team

2013-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ARM A and B: Phase I CP-4055 single agent 1. Patients must have relapsed/refractory leukemias for which no standard therapies are anticipated to result in a durable response or have failed potentially curative therapy, or have refused or are considered unsuitable for standard therapy
• ARM C: CP-4055 in combination with idarubicin
• Patients with relapsed/refractory AML for which no standard therapies are anticipated to result in a durable response or who have failed potentially curative therapy, or who refuse or are considered unsuitable for standard therapy
• ARM A, B, C: CP-4055 as single agent and/or in combination with idarubicin
• Patients must be 18 years of age or older
• Patients must have ECOG performance status (PS) of 0 - 2. See Appendix 3
• Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Nursing patients are excluded.
• Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last CP-4055 dose
• Patients must be capable of understanding and complying with parameters as outlined in the protocol, and able and willing to sign a written informed consent form
• In the absence of rapidly progressing disease, the interval from prior treatment to time of study drug administration should be at least 2 weeks for cytotoxic agents, or at least 5 half-lives for noncytotoxic agents.
• Patients must have the following clinical laboratory values:
• Serum creatinine less or equal to 1.5 x the institutional upper limit of normal (ULN)
• Total bilirubin less or equal to 1.5 x the ULN unless considered due to Gilbert's syndrome
• Alanine aminotransferase (ALT) (SGPT), or aspartate aminotransferase (AST) (SGOT) less or equal to 2.5 x the ULN unless considered due to organ leukemic involvement
• Phase II
• Patients with a confirmed diagnosis of AML who have received cytotoxic chemotherapy
• 2 - 7. Identical to inclusion criteria nos. 2 - 7 for phase I

You may not qualify if…

• Phase I AND II
• A history of allergic reactions or sensitivity attributed to compounds of similar chemical or biologic composition to CP-4055, i.e., ara-C and/or egg
• Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
• Pregnant and nursing patients are excluded
• Uncontrolled intercurrent illness
• Active heart disease
• Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy other than a maximum of 5 g of hydroxyurea to a maximum of 5 days in cycle 1 of therapy
• Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
• Exclusion criteria no. 8 applies only in arm C:
• Patients with hypersensitivity to idarubicin or any other component of the product, and/or other anthracyclines or anthracenediones

Where it is running

• 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

Full record on ClinicalTrials.gov

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